DDrare: Database of Drug Development for Rare Diseases

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	EUCTR2014-001365-26-IT (EUCTR)	05/06/2015	23/03/2015	A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy	A 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, Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2;Phase 3	Portugal;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
2	EUCTR2014-001365-26-ES (EUCTR)	27/05/2015	27/03/2015	A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy	A 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, Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2;Phase 3	Portugal;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
3	EUCTR2014-001365-26-HU (EUCTR)	11/05/2015	25/03/2015	A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy	A 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, Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2;Phase 3	Belarus;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
4	EUCTR2014-001365-26-SE (EUCTR)	11/05/2015	25/03/2015	A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy	A 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, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 2;Phase 3	Belarus;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
5	EUCTR2014-001365-26-DE (EUCTR)	02/02/2015	07/08/2014	A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy	A 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, Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2;Phase 3	Belarus;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
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	NCT02052219 (ClinicalTrials.gov)	October 2014	29/1/2014	BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy	A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy	IgA Nephropathy	Drug: Blisibimod;Drug: Placebo	Anthera Pharmaceuticals	NULL	Withdrawn	18 Years	N/A	Both	0	Phase 3	NULL
7	EUCTR2014-001365-26-CZ (EUCTR)	21/08/2014	22/05/2014	A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy	A 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, Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2;Phase 3	Philippines;Taiwan;Hong Kong;Spain;Thailand;United Kingdom;Italy;Hungary;Czech Republic;Canada;Malaysia;Singapore;Germany;Japan;Sweden;Korea, Republic of
8	NCT02062684 (ClinicalTrials.gov)	June 2013	12/2/2014	BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration	A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy	IgA Nephropathy	Drug: Blisibimod;Drug: Placebo	Anthera Pharmaceuticals	NULL	Completed	18 Years	65 Years	All	57	Phase 2;Phase 3	Czechia;Germany;Hong Kong;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand;United Kingdom;Canada;Czech Republic;Italy;Russian Federation;Spain

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

EUCTR2014-001365-26-IT
(EUCTR)

05/06/2015

23/03/2015

A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy

A 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, Inc

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2;Phase 3

Portugal;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

EUCTR2014-001365-26-ES
(EUCTR)

27/05/2015

27/03/2015

A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy

A 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

Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod

Anthera pharmaceuticals, Inc

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2;Phase 3

EUCTR2014-001365-26-HU
(EUCTR)

11/05/2015

25/03/2015

A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy

Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod

Anthera pharmaceuticals, Inc

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2;Phase 3

Belarus;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

EUCTR2014-001365-26-SE
(EUCTR)

11/05/2015

25/03/2015

A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy

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, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2;Phase 3

Belarus;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

EUCTR2014-001365-26-DE
(EUCTR)

02/02/2015

07/08/2014

A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy

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, Inc

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2;Phase 3

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

NCT02052219
(ClinicalTrials.gov)

October 2014

29/1/2014

BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy

IgA Nephropathy

Drug: Blisibimod;Drug: Placebo

Anthera Pharmaceuticals

NULL

Withdrawn

18 Years

N/A

Both

Phase 3

NULL

EUCTR2014-001365-26-CZ
(EUCTR)

21/08/2014

22/05/2014

A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy

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, Inc

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2;Phase 3

Philippines;Taiwan;Hong Kong;Spain;Thailand;United Kingdom;Italy;Hungary;Czech Republic;Canada;Malaysia;Singapore;Germany;Japan;Sweden;Korea, Republic of

NCT02062684
(ClinicalTrials.gov)

June 2013

12/2/2014

BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration

A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy

IgA Nephropathy

Drug: Blisibimod;Drug: Placebo

Anthera Pharmaceuticals

NULL

Completed

18 Years

65 Years

All

Phase 2;Phase 3

Czechia;Germany;Hong Kong;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand;United Kingdom;Canada;Czech Republic;Italy;Russian Federation;Spain