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	EUCTR2016-002262-31-GB (EUCTR)	17/03/2017	27/01/2017	A 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 KGaA	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2	United States;France;Taiwan;Czech Republic;Spain;Belgium;Singapore;Israel;Japan;Italy;United Kingdom;Korea, Republic of
2	JPRN-JapicCTI-183956	21/2/2017	14/05/2018	A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy	A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy	IgA Nephropathy	Intervention 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.	NULL	complete	20		BOTH	60	Phase 2	Japan, Europe
3	NCT02808429 (ClinicalTrials.gov)	January 31, 2017	16/6/2016	Efficacy and Safety of Atacicept in IgA Nephropathy	A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy	IgA Nephropathy	Drug: Placebo;Drug: Atacicept 25 mg;Drug: Atacicept 75 mg	EMD Serono Research & Development Institute, Inc.	Merck KGaA, Darmstadt, Germany	Completed	18 Years	N/A	All	16	Phase 2	United States;Japan;United Kingdom;Germany

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

EUCTR2016-002262-31-GB
(EUCTR)

17/03/2017

27/01/2017

A 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 KGaA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;France;Taiwan;Czech Republic;Spain;Belgium;Singapore;Israel;Japan;Italy;United Kingdom;Korea, Republic of

JPRN-JapicCTI-183956

21/2/2017

14/05/2018

A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy

IgA Nephropathy

Intervention 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.

NULL

complete

BOTH

Phase 2

Japan, Europe

NCT02808429
(ClinicalTrials.gov)

January 31, 2017

16/6/2016

Efficacy and Safety of Atacicept in IgA Nephropathy

A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy

IgA Nephropathy

Drug: Placebo;Drug: Atacicept 25 mg;Drug: Atacicept 75 mg

EMD Serono Research & Development Institute, Inc.

Merck KGaA, Darmstadt, Germany

Completed

18 Years

N/A

All

Phase 2

United States;Japan;United Kingdom;Germany