DDrare: Database of Drug Development for Rare Diseases

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.

Drug = A-623 or AMG 623; A07EA06; ACE Inhibitor or Angiotensin receptor antagonist; ACE inhibitor; ACE inhibitor + statin; ACE/ARB; ACEI/ARB and corticosteroids; ACEi; ACTH; ACTH (Acthar) Gel; ALN-CC5; APL-2; ARB; ATACICEPT; ATG-F; AVB-S6-500; AZATHIOPRINE; Abelmoschus manihot; Acteoside; Acthar; Acthar 80 unit injection; Aliskiren; Allopurinol; Angiotensin; Angiotensin II; Angiotensin blockade; Artesunate; Atacicept; Atacicept 25 mg; Atacicept 75 mg; Atacicept150mg; Atacicept25mg; Atacicept75mg; Atrasentan; Azathioprine; BENLYSTA® (belimumab); BION-1301 Multiple Doses; BION-1301 Single Dose; BUDESONIDE; Bardoxolone; Bardoxolone methyl; Bardoxolone methyl capsules; Belimumab; Benlysta; Blisibimod; Blisibimod Injection; Blood sample; Bortezomib; Bortezomib (Velcade®); Budesonide; CCX168; CEMDISIRAN; CYCLOPHOSPHAMIDE; Calcitriol; Cemdisiran; Chinese Herb Prescription Granule plus prednisone; Cilazapril; Corticosteroid; Corticotherapy; Cyclophosphamid; Cyclophosphamide; Decortin H; Dipyridamole; ENALAPRIL VALSARTAN METHYLPREDNISONE; Enalapril; FOS; FOSTAMATINIB DISODIUM; Fecal microbiota transplantation; Fish oil; Fostamatinib; Fostamatinib 100 mg; Fostamatinib 100 mg tablet; Fostamatinib 150 mg; Fostamatinib 150 mg tablet; Fostamatinib Disodium tablet 100 mg; Fostamatinib Disodium tablet 150 mg; GSK1550188; Gastrus; High Dose-VIS649; Hormone (prednisone); Human soluble recombinant Fc-gamma receptor IIB; Hydroxychloroquine; Hydroxychloroquine Sulfate; IONIS-FB-LRx; IRBESARTAN; Immunosuppressants; Immunosuppressive treatment; Infusion of ADR-001 (Mesenchymal stem cell); Inhibace/Cozaar; Intervention for incipient patients at low risk of disease progression; Intervention for patients at high risk of disease progression; Intravenous Rituximab; Iptacopan; Irbesartan; Irbesartan approved in the Netherlands; Irbesartan tablets; Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03; Irbesartan tablets (NDC# 0955-1041-90 approved in the USA); Irbesartan tablets (NDC# 43547-375-50 approved in the USA) Generic tablets distributed by Solco Healthcare US, LLC; LNP023; Leflunomide; Leflunomide 20 mg+prednisone 0.5mg/kg/d; Lisinopril; Losartan; Low Dose-VIS649; Low antigen content diet; METHYLPREDNISOLONE; METHYLPREDNISOLONE MYLAN Générique; MMF; Medium Dose-VIS649; Menatetrenone; Methylprednisolon; Methylprednisolone; Methylprednisolone (MP) or prednisone (pred); Methylprednisolone pulse; Methylprednisolone(intravenously in the 1st-2nd-3rd month ); Methylprednisolone(intravenously in the 1st-3rd-5th month); Methylprednisone; Mizoribine; Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH); Mycophenolat-Natrium; Mycophenolate; Mycophenolate Mofetil; Mycophenolate Mofetil (MMF); Mycophenolate mofetil; Mycophenolate mofetil (MMF); Mycophenolate mofetil plus lower dose of Prednisone; Mycophenolate sodium; Mycophenolic acid; Mycophenolic sodium; Myfortic; Myfortic 180mg Tablets; Myfortic 360mg Tablets; NEFECON; Narsoplimab; Nefecon; OMS721; OMS721 (narsoplimab); OPL-CCL2-LPM; Omega-3; Omega-3 Fatty Acid Fish Oil Supplement; Omega-3 fatty acid; Omega-3 fatty acid ethylester90; Other: Optimized Supportive Care; Other: Vehicle (D5W or saline); Other: continue their usual therapy; Other: intensive supportive care; Over-encapsulated 150 mg Irbesartan Tablets; Over-encapsulated Irbesartan; Over-encapsulated Irbesartan Tablets; Over-encapsulated Irbesartan tablets; PREDNISOLONE; PREDNISONE; PREDNISONE ARROW 20mg; PREDNISONE ARROW 5 mg; Paricalcitol; Placebo; Potassium; Prednisolon; Prednisolone; Prednisone; Prednisone + Inhibace/Cozaar; Prednisone 5 mg; Prednisone alone; Prednisone and cyclophosphamide; Prednisone in full dose; Prednisone or Prednisolone; Prednisone plus cyclophosphamide; ProTectis; Probucol; Procedure: Plasma Exchange (PE); R935788; RAPAMUNE; RAS; RAS 2410; RC18 160mg; RC18 240mg; RE-021; Ramipril; Rapamune; Reh-acteoside; Renin Angiotensin system (RAS) blockade; Risedronate; Rituximab; SIROLIMUS; SM101; SPARSENTAN; Simulect; Simvastatin; Sirolimus; Sirolimus (study drug)+ACE inhibitor + statin; Sparsentan; Sparsentan tablets; Sparsentan tablets/ Over-encapsulated Sparsentan tablets; Sparsentan tablets/Over-encapsulated Sparsentan tablets; Sparsentan tablets/Overencapsulated Sparsentan tablets; Steroids; Steroids plus azathioprine; Sulfate; Supportive and immunosuppressive therapy; Supportive therapy; Supportive therapy with: ACE-inhibitor / ARB / Statin; Tacrolimus; Tailored diet; Telmisartan; The Yi-Qi-Qing-Jie herbal compound; Tripterygium; Tripterygium Wilfordii; Tripterygium wilfordii (TW); VIS649; Valsartan; WM (Shentong Granules); Warfarin;  LNP023 HYDROCHLORIDE SALT

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2020-001049-38-HU (EUCTR)	17/12/2020	27/10/2020	Study of efficacy and safety of LNP023 in primary IgA nephropathy patients	A 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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	United 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
2	EUCTR2017-000891-27-IT (EUCTR)	18/12/2019	30/09/2019	Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy	An 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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 2	United 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
3	EUCTR2017-000891-27-FR (EUCTR)	29/10/2019	12/08/2019	Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy	An 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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 2	United 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
4	EUCTR2017-000891-27-CZ (EUCTR)	10/10/2019	03/07/2019	Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy	An 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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	96	Phase 2	United 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
5	EUCTR2017-000891-27-HU (EUCTR)	25/09/2019	30/07/2019	Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy	An 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 AG	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United 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.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2017-000891-27-NL (EUCTR)	25/05/2018	09/04/2018	A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy	An 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 AG	Novartis Pharma AG	Not Recruiting			Female: yes Male: yes	218	Phase 2	United States;Taiwan;Finland;Thailand;Italy;United Kingdom;France;Hungary;Czech Republic;Argentina;Belgium;Singapore;Australia;Denmark;Netherlands;Germany;Norway;China;Korea, Republic of;Sweden
7	EUCTR2017-000891-27-DK (EUCTR)	25/05/2018	11/04/2018	A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy	An 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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	96	Phase 2	United 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
8	EUCTR2017-000891-27-DE (EUCTR)	06/04/2018	24/11/2017	A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy	An 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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	96	Phase 2	United 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
9	EUCTR2017-000891-27-SE (EUCTR)	19/02/2018	17/10/2017	A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy	An 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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	96	Phase 2	United 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
10	EUCTR2017-000891-27-FI (EUCTR)	09/01/2018	23/11/2017	A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy	An 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 AG	NULL	Not Recruiting			Female: yes Male: yes	96	Phase 2	United 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
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2017-000891-27-GB (EUCTR)	21/11/2017	06/10/2017	A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy	An 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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	96	Phase 2	United 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.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2020-001049-38-HU
(EUCTR)

17/12/2020

27/10/2020

Study of efficacy and safety of LNP023 in primary IgA nephropathy patients

A 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 AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

United 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

EUCTR2017-000891-27-IT
(EUCTR)

18/12/2019

30/09/2019

Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy

An 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 AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 2

United 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

EUCTR2017-000891-27-FR
(EUCTR)

29/10/2019

12/08/2019

Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy

An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 2

United 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

EUCTR2017-000891-27-CZ
(EUCTR)

10/10/2019

03/07/2019

Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy

An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients

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 AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

EUCTR2017-000891-27-HU
(EUCTR)

25/09/2019

30/07/2019

Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy

An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-000891-27-NL
(EUCTR)

25/05/2018

09/04/2018

A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy

An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients

Novartis Pharma AG

Not Recruiting

Female: yes
Male: yes

218

Phase 2

United States;Taiwan;Finland;Thailand;Italy;United Kingdom;France;Hungary;Czech Republic;Argentina;Belgium;Singapore;Australia;Denmark;Netherlands;Germany;Norway;China;Korea, Republic of;Sweden

EUCTR2017-000891-27-DK
(EUCTR)

25/05/2018

11/04/2018

A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy

An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

EUCTR2017-000891-27-DE
(EUCTR)

06/04/2018

24/11/2017

A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy

An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

EUCTR2017-000891-27-SE
(EUCTR)

19/02/2018

17/10/2017

A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy

An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

EUCTR2017-000891-27-FI
(EUCTR)

09/01/2018

23/11/2017

A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy

An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United 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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-000891-27-GB
(EUCTR)

21/11/2017

06/10/2017

A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy

An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2