66. IgA腎症 [臨床試験数:199,薬物数:214(DrugBank:57),標的遺伝子数:32,標的パスウェイ数:128

Searched query = "IgA nephropathy", "IgA nephritis", "Berger disease", "IgA-IgG nephropathy"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
85 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04578834
(ClinicalTrials.gov)
January 27, 20219/9/2020Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy PatientsA Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy PatientsIgA NephropathyDrug: Placebo;Drug: LNP023Novartis PharmaceuticalsNULLNot yet recruiting18 YearsN/AAll450Phase 3NULL
2EUCTR2020-001049-38-HU
(EUCTR)
17/12/202027/10/2020Study of efficacy and safety of LNP023 in primary IgA nephropathy patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Thailand;Spain;Israel;Russian Federation;Colombia;Italy;Vietnam;India;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
3NCT04573478
(ClinicalTrials.gov)
December 1, 202012/9/2020Atrasentan in Patients With IgA NephropathyA Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal FunctionIgA Nephropathy;Immunoglobulin A NephropathyDrug: Atrasentan;Drug: PlaceboChinook Therapeutics U.S., Inc.NULLNot yet recruiting18 YearsN/AAll320Phase 3NULL
4ChiCTR2000038104
2020-09-012020-09-10Efficacy and safety of Artesunate for patients with IgA nephropathy: a multicenter, double-blind, randomized, placebo-controlled trial.Efficacy and safety of Artesunate for patients with IgA nephropathy: a multicenter, double-blind, randomized, placebo-controlled trial. IgA nephropathyGroup 1:Artesunate 100mg (50mg/Bid);Group 2:Artesunate 50mg (25mg/Bid);The control group:Placebo;Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese MedicineNULLRecruitingBothGroup 1:40;Group 2:40;The control group:40;China
5NCT04287985
(ClinicalTrials.gov)
July 20, 202010/2/2020Safety and Efficacy Study of VIS649 for IgA NephropathyA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants With Immunoglobulin A (IgA) NephropathyImmunoglobulin A Nephropathy;Glomerular Disease;IgANDrug: Dose-Placebo;Drug: Low Dose-VIS649;Drug: Medium Dose-VIS649;Drug: High Dose-VIS649Visterra, Inc.NULLRecruiting18 YearsN/AAll144Phase 2United States;Japan;Korea, Republic of;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-002531-29-GB
(EUCTR)
24/03/202017/12/2019A study to look at the effect and how safe drug VIS649 is in patients with kidney diseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants with Immunoglobulin A (IgA) Nephropathy Immunoglobulin A (IgA) Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: VIS649
Product Code: VIS649
INN or Proposed INN: VIS649
Other descriptive name: VIS649
Product Name: VIS649
Product Code: VIS649
INN or Proposed INN: VIS649
Other descriptive name: VIS649
Product Name: VIS649
Product Code: VIS649
INN or Proposed INN: VIS649
Other descriptive name: VIS649
Visterra, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
144Phase 2United States;Philippines;Hong Kong;Taiwan;Thailand;Spain;United Kingdom;India;Czech Republic;Canada;Malaysia;Singapore;Australia;Japan;Korea, Republic of
7NCT04291781
(ClinicalTrials.gov)
March 202027/2/2020A Study of RC18 Administered Subcutaneously to Subjects With IgA(Immunoglobulin A) NephropathyPhase II Clinical Trial of RC18(Recombinant Human B Lymphocyte Stimulator Receptor - Antibody Fusion Protein for Injection) in the Treatment of IgA NephropathyIgA NephropathyBiological: RC18 160mg;Biological: RC18 240mg;Biological: placeboRemeGenNULLRecruiting18 Years70 YearsAll30Phase 2China
8EUCTR2018-000075-33-DE
(EUCTR)
19/12/201901/07/2019OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Code: OMS721
INN or Proposed INN: OMS721
Other descriptive name: OMS721
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden
9EUCTR2017-000891-27-IT
(EUCTR)
18/12/201930/09/2019Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
10EUCTR2018-000075-33-GB
(EUCTR)
06/11/201927/06/2019OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Code: OMS721
INN or Proposed INN: OMS721
Other descriptive name: OMS721
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Philippines;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Germany;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-000891-27-FR
(EUCTR)
29/10/201912/08/2019Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
12EUCTR2017-000891-27-CZ
(EUCTR)
10/10/201903/07/2019Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
13EUCTR2017-000891-27-HU
(EUCTR)
25/09/201930/07/2019Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
14NCT03418779
(ClinicalTrials.gov)
July 4, 201911/1/2018Treatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of ESRDTreatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of End-stage Renal Disease (TCM-WINE)IgA Nephropathy at High Risk of Developing ESRDDrug: The Yi-Qi-Qing-Jie herbal compound;Drug: Immunosuppressants;Other: Optimized Supportive Care;Other: Yi-Qi-Qing-Jie herbal compound placeboGuang'anmen Hospital of China Academy of Chinese Medical SciencesChina Academy of Chinese Medical SciencesRecruiting18 Years70 YearsAll60Phase 2/Phase 3China
15EUCTR2018-002716-27-GB
(EUCTR)
11/06/201907/01/2019A Phase 2 Study of Cemdisiran in Adult Patients with IgA NephropathyA Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients with IgA Nephropathy - A Phase 2 Study of Cemdisiran in Adult Patients with IgA Nephropathy Immunoglobulin A nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: cemdisiran
Other descriptive name: CEMDISIRAN
Alnylam Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2United States;France;Philippines;Taiwan;Canada;Spain;Malaysia;Singapore;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2018-002716-27-SE
(EUCTR)
28/05/201906/02/2019A Phase 2 Study of Cemdisiran in Adult Patients with IgA NephropathyA Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients with IgA Nephropathy - A Phase 2 Study of Cemdisiran in Adult Patients with IgA Nephropathy Immunoglobulin A nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: cemdisiran
Other descriptive name: CEMDISIRAN
Alnylam Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2United States;France;Philippines;Taiwan;Canada;Spain;Malaysia;Singapore;United Kingdom;Sweden
17EUCTR2017-004366-10-GB
(EUCTR)
24/05/201904/02/2019Efficacy and Safety of Belimumab in the Treatment of IgA NephropathyA Phase 2 Placebo-controlled Double Blinded Study to Assess the Efficacy and Safety of Belimumab in Subjects with Immunoglobulin A Nephropathy (IgAN) - Efficacy and Safety of Belimumab in the Treatment of IgA Nephropathy Immunoglobulin A (IgA) nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
University of LeicesterNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
21 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
18NCT03841448
(ClinicalTrials.gov)
April 24, 201913/2/2019A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients With IgA NephropathyIgA Nephropathy (IgAN);Berger Disease;Glomerulonephritis, IgADrug: Placebo;Drug: CemdisiranAlnylam PharmaceuticalsNULLRecruiting18 Years65 YearsAll30Phase 2United States;Canada;France;Malaysia;Philippines;Singapore;Spain;Sweden;Taiwan;United Kingdom
19NCT03945318
(ClinicalTrials.gov)
April 8, 201921/4/2019Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)A Phase 1, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA NephropathyIgA NephropathyDrug: BION-1301 Single Dose;Drug: Placebo Single Dose;Drug: BION-1301 Multiple Doses;Drug: Placebo Multiple DosesAduro Biotech, Inc.NULLRecruiting18 YearsN/AAll92Phase 1United States;United Kingdom
20EUCTR2018-002716-27-ES
(EUCTR)
08/04/201912/04/2019A Phase 2 Study of Cemdisiran in Adult Patients with IgA NephropathyA Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients with IgA Nephropathy - A Phase 2 Study of Cemdisiran in Adult Patients with IgA Nephropathy Immunoglobulin A nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Alnylam Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Philippines;Taiwan;Spain;United Kingdom;France;Canada;Malaysia;Singapore;Australia;Germany;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21ChiCTR1900022100
2019-04-012019-03-25Evaluation of clinical efficacy of Modified Huangqi Chifeng Decoction in treating IgA Nephropathy proteinuia based on Chinese medicine pathogenesis of deficiency-wind-stasis -toxin”Evaluation of clinical efficacy of Modified Huangqi Chifeng Decoction in treating IgA Nephropathy proteinuia based on Chinese medicine pathogenesis of deficiency-wind-stasis -toxin” IgA nephropathyPlacebo Group:Placebo+telmisartan;Experimental group:Flavoured huangqi chifeng granules+telmisartan;Xiyuan Hospital, China Academy of Chinese Medical SciencesNULLRecruitingBothPlacebo Group:40;Experimental group:40;N/AChina
22EUCTR2018-000075-33-AT
(EUCTR)
15/11/201825/06/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN)
MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Philippines;Taiwan;Slovakia;Spain;Lithuania;Austria;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Sweden;Korea, Republic of
23NCT03719443
(ClinicalTrials.gov)
October 9, 201810/10/2018First in Human Study to Assess Safety of VIS649 in Healthy SubjectsA Phase 1, Randomized, Placebo-Controlled, Single Ascending Dose First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VIS649 Administered Intravenously in Healthy SubjectsImmunoglobulin A Nephropathy;IgAN - IgA Nephropathy;IgA NephropathyBiological: VIS649;Biological: PlaceboVisterra, Inc.NULLCompleted18 Years55 YearsAll41Phase 1United States
24EUCTR2018-000075-33-BE
(EUCTR)
03/10/201831/05/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Omeros CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Philippines;Taiwan;Slovakia;Spain;Lithuania;Austria;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Sweden;Korea, Republic of
25EUCTR2018-000075-33-PL
(EUCTR)
17/09/201810/07/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN)
MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: OMS721
INN or Proposed INN: OMS721
Other descriptive name: OMS721
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2018-000075-33-CZ
(EUCTR)
06/09/201806/04/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN)
MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: OMS721
INN or Proposed INN: OMS721
Other descriptive name: OMS721
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Philippines;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Germany;Sweden;Korea, Republic of
27EUCTR2018-000075-33-BG
(EUCTR)
05/09/201819/07/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN)
MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: OMS721
INN or Proposed INN: OMS721
Other descriptive name: OMS721
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden
28NCT03643965
(ClinicalTrials.gov)
September 5, 20188/8/2018Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) NephropathyA Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd)Primary IgA NephropathyDrug: Nefecon;Drug: Placebo oral capsuleCalliditas Therapeutics ABNULLRecruiting18 YearsN/AAll360Phase 3United States;Argentina;Australia;Belarus;Belgium;Canada;Czechia;Finland;France;Germany;Greece;Italy;Korea, Republic of;Poland;Spain;Sweden;Taiwan;Turkey;United Kingdom
29EUCTR2018-000075-33-SE
(EUCTR)
03/09/201803/05/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN)
MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: OMS721
INN or Proposed INN: OMS721
Other descriptive name: OMS721
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Slovakia;Thailand;Spain;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Sweden;Korea, Republic of
30EUCTR2017-004902-16-PL
(EUCTR)
27/08/201818/07/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). - NefIgArd Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2018-000075-33-ES
(EUCTR)
01/08/201821/05/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Code: OMS721
INN or Proposed INN: OMS721
Other descriptive name: OMS721
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
434Phase 3United States;Slovakia;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Sweden
32EUCTR2017-004902-16-FI
(EUCTR)
18/07/201802/03/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Other descriptive name: Nefecon
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of
33EUCTR2018-000075-33-SK
(EUCTR)
21/06/201820/04/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN)
MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: OMS721
INN or Proposed INN: OMS721
Other descriptive name: OMS721
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Philippines;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Germany;Sweden;Korea, Republic of
34EUCTR2017-004902-16-BE
(EUCTR)
18/06/201821/02/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Korea, Republic of;Sweden
35EUCTR2018-000075-33-LT
(EUCTR)
15/06/201823/04/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Code: OMS721
INN or Proposed INN: OMS721
Other descriptive name: OMS721
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Taiwan;Slovakia;Thailand;Spain;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2018-000075-33-HU
(EUCTR)
07/06/201829/03/2018OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Code: OMS721Omeros CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
434Phase 3United States;Hungary;Canada;Australia
37EUCTR2017-004902-16-CZ
(EUCTR)
04/06/201812/02/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Other descriptive name: Nefecon
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of
38EUCTR2017-004902-16-GB
(EUCTR)
29/05/201822/06/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Other descriptive name: Nefecon
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of
39EUCTR2017-000891-27-DK
(EUCTR)
25/05/201811/04/2018A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
40EUCTR2017-000891-27-NL
(EUCTR)
25/05/201809/04/2018A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNovartis Pharma AGNot RecruitingFemale: yes
Male: yes
218Phase 2United States;Taiwan;Finland;Thailand;Italy;United Kingdom;France;Hungary;Czech Republic;Argentina;Belgium;Singapore;Australia;Denmark;Netherlands;Germany;Norway;China;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2017-000891-27-BE
(EUCTR)
22/05/201819/03/2018A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden
42EUCTR2017-004902-16-ES
(EUCTR)
09/04/201802/03/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Other descriptive name: Nefecon
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Korea, Republic of;Sweden
43EUCTR2017-000891-27-DE
(EUCTR)
06/04/201824/11/2017A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
44EUCTR2017-004902-16-SE
(EUCTR)
28/03/201813/02/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Other descriptive name: Nefecon
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Korea, Republic of;Sweden
45EUCTR2017-000891-27-SE
(EUCTR)
19/02/201817/10/2017A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT03608033
(ClinicalTrials.gov)
February 16, 201821/6/2018Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) NephropathyA Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy (ARTEMIS - IGAN)IgA NephropathyBiological: OMS721;Other: Vehicle (D5W or saline)Omeros CorporationNULLRecruiting18 YearsN/AAll450Phase 3United States;Australia;Austria;Belgium;Bulgaria;Hungary;Lithuania;Poland;Slovakia;Spain
47NCT03373461
(ClinicalTrials.gov)
February 7, 201830/11/2017Study of Safety and Efficacy of LNP023 in Patients With Kidney Disease Caused by InflammationAn Adaptive Seamless Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Investigate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy PatientsIgA NephropathyDrug: LNP023;Drug: PlaceboNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll146Phase 2United States;Argentina;Australia;Belgium;Brazil;China;Colombia;Czechia;Denmark;Finland;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Malaysia;Netherlands;Norway;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;United Kingdom
48EUCTR2017-000891-27-FI
(EUCTR)
09/01/201823/11/2017A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
96Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
49EUCTR2017-000891-27-GB
(EUCTR)
21/11/201706/10/2017A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathyAn adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients Primary IgA Nephropathy
MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: LNP023
INN or Proposed INN: Iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden
50EUCTR2016-002262-31-GB
(EUCTR)
17/03/201727/01/2017A Clinical Trial to Examine the Effects of the Drug Atacicept in Patients with Nephropathy (Diabetic Kidney Disease).A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy IgA Nephropathy
MedDRA version: 20.1;Level: PT;Classification code 10061835;Term: Diabetic nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
50Phase 2United States;France;Taiwan;Czech Republic;Spain;Belgium;Singapore;Israel;Japan;Italy;United Kingdom;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51JPRN-JapicCTI-183956
21/2/201714/05/2018A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA NephropathyA Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy IgA NephropathyIntervention name : Atacicept25mg
INN of the intervention : Atacicept
Dosage And administration of the intervention : Subject will receive Atacicept 25 milligram (mg) once weekly as a subcutaneous (SC) injection for 72 weeks.
Intervention name : Atacicept75mg
INN of the intervention : Atacicept
Dosage And administration of the intervention : Subject will receive Atacicept 75 mg once weekly as an SC injection for 72 weeks.
Intervention name : Atacicept25mg
INN of the intervention : Atacicept
Dosage And administration of the intervention : Subject will receive Atacicept 25 mg once weekly as an SC injection for 156 weeks.
Intervention name : Atacicept75mg
INN of the intervention : Atacicept
Dosage And administration of the intervention : Subject will receive Atacicept 75 mg once weekly as an SC injection for 156 weeks.
Intervention name : Atacicept150mg
INN of the intervention : Atacicept
Dosage And administration of the intervention : Subject will receive Atacicept 150 mg once weekly as an SC injection for 156 weeks.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Subject will receive matching Placebo to atacicept once weekly as an SC injection for 72 weeks.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Subject will receive matching Placebo to atacicept once weekly as an SC injection for 156 weeks.
Merck Biopharma Co., Ltd.NULLcomplete20BOTH60Phase 2Japan, Europe
52NCT02808429
(ClinicalTrials.gov)
January 31, 201716/6/2016Efficacy and Safety of Atacicept in IgA NephropathyA Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA NephropathyIgA NephropathyDrug: Placebo;Drug: Atacicept 25 mg;Drug: Atacicept 75 mgEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyCompleted18 YearsN/AAll16Phase 2United States;Japan;United Kingdom;Germany
53NCT02942381
(ClinicalTrials.gov)
September 13, 201614/10/2016A Study of Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA NephropathyIgA Patients;HydroxychloroquineDrug: Hydroxychloroquine Sulfate;Drug: PlaceboPeking University First HospitalNULLCompleted18 Years75 YearsAll60Phase 2China
54NCT02605525
(ClinicalTrials.gov)
December 201512/11/2015Efficacy and Safety of SM101 in the Treatment of IgA NephropathyA Phase 2 Study to Assess the Efficacy and Safety of Intravenous Infusion With Human Soluble Recombinant Fc-gamma Receptor IIB (SM101/BAX 1810) in Subjects With Immunoglobulin A Nephropathy (IgAN)Immunoglobulin A NephropathyBiological: SM101;Other: PlaceboBaxalta now part of ShireNULLWithdrawn18 YearsN/AAll0Phase 2NULL
55EUCTR2014-001365-26-IT
(EUCTR)
05/06/201523/03/2015A study to evaluate the safety and efficacy of Blisibimod in IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration IgA Nephropathy
MedDRA version: 17.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod
Anthera pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2/3Portugal;Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Netherlands;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2014-001365-26-ES
(EUCTR)
27/05/201527/03/2015A study to evaluate the safety and efficacy of Blisibimod in IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration IgA Nephropathy
MedDRA version: 17.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod
Anthera pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2;Phase 3Portugal;Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Netherlands;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden
57EUCTR2014-001365-26-SE
(EUCTR)
11/05/201525/03/2015A study to evaluate the safety and efficacy of Blisibimod in IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration IgA Nephropathy
MedDRA version: 18.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod
Anthera pharmaceuticals, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2/3Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden
58EUCTR2014-001365-26-HU
(EUCTR)
11/05/201525/03/2015A study to evaluate the safety and efficacy of Blisibimod in IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration IgA Nephropathy
MedDRA version: 17.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod
Anthera pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2/3Belarus;Portugal;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Netherlands;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Georgia;Bulgaria;Germany;Japan;Sweden
59EUCTR2014-001365-26-DE
(EUCTR)
02/02/201507/08/2014A study to evaluate the safety and efficacy of Blisibimod in IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration IgA Nephropathy
MedDRA version: 19.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod
Anthera pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2;Phase 3Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden
60NCT02052219
(ClinicalTrials.gov)
October 201429/1/2014BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA NephropathyIgA NephropathyDrug: Blisibimod;Drug: PlaceboAnthera PharmaceuticalsNULLWithdrawn18 YearsN/ABoth0Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT02112838
(ClinicalTrials.gov)
October 201410/4/2014Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) NephropathyA Phase 2, Multi-Center, Randomised, Double-Blind, Ascending-Dose, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of IgA NephropathyIGA NephropathyDrug: Fostamatinib 150 mg;Drug: Fostamatinib 100 mg;Drug: PlaceboRigel PharmaceuticalsNULLCompleted18 Years70 YearsAll76Phase 2United States;Austria;Germany;Hong Kong;Taiwan;United Kingdom;Singapore;Switzerland
62EUCTR2014-000331-16-AT
(EUCTR)
25/08/201422/07/2014N/AA Phase 2, Multi-Center, Randomised, Double-Blind, Ascending-Dose, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of IgA Nephropathy - N/A IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Product Name: Fostamatinib 100 mg tablet
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: FOSTAMATINIB DISODIUM
Product Name: Fostamatinib 150 mg tablet
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: FOSTAMATINIB DISODIUM
Rigel Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Hong Kong;Taiwan;Singapore;Austria;United Kingdom;Switzerland
63EUCTR2014-001365-26-CZ
(EUCTR)
21/08/201422/05/2014A study to evaluate the safety and efficacy of Blisibimod in IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod
Anthera Pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2;Phase 3Philippines;Taiwan;Hong Kong;Spain;Thailand;United Kingdom;Italy;Hungary;Czech Republic;Canada;Malaysia;Singapore;Germany;Japan;Sweden;Korea, Republic of
64EUCTR2014-000331-16-GB
(EUCTR)
28/07/201408/05/2014N/AA Phase 2, Multi-Center, Randomised, Double-Blind, Ascending-Dose, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of IgA Nephropathy - N/A IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Rigel Pharmaceuticals IncNULLNot Recruiting Female: yes
Male: yes
92 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hong Kong;Taiwan;Singapore;Austria;Switzerland;United Kingdom
65NCT02062684
(ClinicalTrials.gov)
June 201312/2/2014BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous AdministrationA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA NephropathyIgA NephropathyDrug: Blisibimod;Drug: PlaceboAnthera PharmaceuticalsNULLCompleted18 Years65 YearsAll57Phase 2/Phase 3Czechia;Germany;Hong Kong;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand;United Kingdom;Canada;Czech Republic;Italy;Russian Federation;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2012-001923-11-ES
(EUCTR)
09/01/201329/11/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 14.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
67EUCTR2012-001923-11-NL
(EUCTR)
18/12/201219/10/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 16.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden
68EUCTR2012-001923-11-DE
(EUCTR)
10/12/201222/08/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Pharmalink ABNULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
69NCT01738035
(ClinicalTrials.gov)
December 201225/7/2012The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal DiseaseA Multicentre, Interventional Treatment, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon in Primary IgA Nephropathy Patients at Risk of End-stage Renal DiseasePrimary IgA NephropathyDrug: NEFECON;Other: PlaceboPharmalink ABNULLCompleted18 YearsN/ABoth150Phase 2Belgium;Czech Republic;Denmark;Finland;Germany;Italy;Netherlands;Spain;Sweden;United Kingdom
70EUCTR2012-001923-11-SE
(EUCTR)
21/11/201203/09/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2012-001923-11-BE
(EUCTR)
19/11/201222/08/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
72EUCTR2012-001923-11-GB
(EUCTR)
06/11/201228/09/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
73EUCTR2012-001923-11-DK
(EUCTR)
05/11/201214/09/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
74EUCTR2012-001923-11-CZ
(EUCTR)
24/10/201216/08/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
75EUCTR2012-001923-11-FI
(EUCTR)
17/10/201215/08/2012A study to assess if two different doses of Nefecon (budesonide) compared to placebo are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2012-001923-11-IT
(EUCTR)
27/09/201224/09/2012A study to assess if two different doses of Nefecon taken as a capsule are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional treatment, Randomised, Double-Blind, Single Group Assignment Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon in primary IgA nephropathy patients at risk of developing end-stage renal disease - NEFIGAN Trial Primary IgA nephropathy at risk of developing end stage renal disease
MedDRA version: 15.0;Level: LLT;Classification code 10037034;Term: Proteinuria present;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: A07EA06
INN or Proposed INN: BUDESONIDE
CROWN OYNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
77NCT01560052
(ClinicalTrials.gov)
April 201215/3/2012Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study (TESTING Low Dose Study)Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study Low Dose StudyIgA GlomerulonephritisDrug: methylprednisolone;Drug: PlaceboThe George InstitutePeking University First HospitalActive, not recruiting18 YearsN/AAll503N/AAustralia;Canada;China;Hong Kong;India;Malaysia
78NCT01224028
(ClinicalTrials.gov)
November 201018/10/2010A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy PatientsDouble-blind, Randomized Placebo-controlled Clinical Trial for the Efficacy and Safety of a Calcineurin Inhibitor, Tacrolimus(Prograf Cap®) in Patients With Non-nephrotic Albuminuric, Normotensive IgA NephropathyIgA NephropathyDrug: Tacrolimus;Drug: PlaceboAstellas Pharma IncAstellas Pharma Korea, Inc.Completed18 Years70 YearsBoth40Phase 2Korea, Republic of
79ChiCTR-TRC-10000776
2010-02-272010-02-10A Study on the Efficacy and Safety of Telmisartan, Clopidogrelin and Leflunomide in patients with IgA nephropathyA Study on the Efficacy and Safety of Telmisartan, Clopidogrelin and Leflunomide in patients with IgA nephropathy lgA nephropathy;ICD:N03.81:Telmisartan+ Clopidogrelin placebo + Leflunomide placebo ;2:Telmisartan + Clopidogrelin+ Leflunomide placebo ;3:Telmisartan + Clopidogrelin placebo + Leflunomide;4:Telmisartan + Clopidogrelin + Leflunomide;Chinese General Hospital of PLANULLCompleted1855Both1:100;2:100;3:100;4:100;China
80ChiCTR-TRC-10000824
2010-01-012010-04-06the clinical effect of Fufang Shenyan Tablet on IgA Nephropathy patientsMulticenter, randomized, double-blind, placebo-controlled clinical research of the clinical effect of Fufang Shenyan Tablet on IgA Nephropathy patients IgA Nephropathythe control group:The 24-hour urinary protein 0.5-2.0g: Lotensin 10mg, bid; placebos 2.5g tid; The 24-hour urinary protein 2.0-3.5g: on this basis, combined with prednisone 40mg/d; If patients with hypertension(target blood pressure <=130/80mmHg), used Lotensin 10mg bid alone control it difficultly, give Norvasc 5mg, qd~bid instead; if still poorly controlled, combined with Betaloc 12.5mg, bid;the treatment group:The 24-hour urinary protein 0.5-2.0g: Lotensin 10mg, bid; Fufang Shenyan Tablets 2.5g tid; The 24-hour urinary protein 2.0-3.5g: on this basis, combined with prednisone 40mg/d; If patients with hypertension (target blood pressure <=130/80mmHg), used Lotensin 10mg bid alone control it difficultly, give Norvasc 5mg, qd~bid instead; if still poorly controlled, combined with Betaloc 12.5mg, bid;The First Affiliated Hospital of Xi'an Jiaotong University Medical CollegeNULLCompleted1865Boththe control group:60;the treatment group:60;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT01879514
(ClinicalTrials.gov)
January 201025/3/2013Study of Standardized Treatment of Integrative Medicine With the Severe IgA NephropathStudy of Standardized Treatment of Integrative Medicine With the Severe IgA NephropathIgA NephropathyDrug: Chinese Herb Prescription Granule plus prednisone;Drug: PlaceboShanghai University of Traditional Chinese MedicineShanghai Sixth People's Hospital;RenJi HospitalRecruiting18 Years60 YearsBoth200N/AChina
82NCT00870493
(ClinicalTrials.gov)
April 200926/3/2009Aliskiren for Immunoglobulin A (IgA) NephropathyThe Safety and Short-Term Efficacy of Aliskiren in the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over StudyIgA NephropathyDrug: Aliskiren;Drug: PlaceboChinese University of Hong KongNULLCompleted18 Years65 YearsBoth22Phase 3Hong Kong
83NCT00549692
(ClinicalTrials.gov)
November 200725/10/2007Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of Immunoglobulin A NephropathyMinimization, Double-blind, Placebo-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of IgA NephropathyIgA NephropathyDrug: Omega-3 fatty acid ethylester90Kuhnil Pharmaceutical Co., Ltd.Pronova BioPharma ASACompleted18 YearsN/ABoth152Phase 3Korea, Republic of
84NCT00426348
(ClinicalTrials.gov)
May 200723/1/2007A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA NephropathyA Prospective Randomized, Controlled, Double Blinded Trial of the Antioxidant Probucol Combined With Valsartan in Patients With IgA NephropathyGlomerulonephritis;IGA NephropathyDrug: Valsartan;Drug: Probucol;Drug: PlaceboGuangdong General HospitalNULLCompleted18 Years60 YearsBoth75Phase 4China
85NCT00318474
(ClinicalTrials.gov)
January 200224/4/2006Mycophenolate Mofetil (MMF) in Patients With IgA NephropathyA Randomized Controlled Trial of Mycophenolate Mofetil in Patients With IgA NephropathyIgA NephropathyDrug: Mycophenolate Mofetil (MMF);Drug: MMF Placebo;Drug: ACEi;Drug: FOSSt. Joseph's Hospital and Medical Center, PhoenixNULLTerminated7 Years70 YearsAll184Phase 3United States