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	EUCTR2017-004605-41-GB (EUCTR)	04/10/2018	04/06/2018	Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)	A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy - 021IGAN17001 (PROTECT) Sparsentan in IGAN	Immunoglobulin A Nephropathy (IgAN) MedDRA version: 20.0;Level: PT;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: Sparsentan tablets/Overencapsulated Sparsentan tablets Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03 Product Name: Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03 INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: Irbesartan tablets INN or Proposed INN: Irbesartan Other descriptive name: Irbesartan Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN	Retrophin, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	380	Phase 3	United States;Portugal;Taiwan;Estonia;Hong Kong;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of
2	EUCTR2017-004605-41-ES (EUCTR)	27/09/2018	30/07/2018	Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)	A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy	Immunoglobulin A Nephropathy (IgAN) MedDRA version: 20.0;Level: PT;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: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03 Product Name: over-encapsulated 150 mg Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN	Retrophin, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 3	Portugal;United States;Estonia;Hong Kong;Spain;Lithuania;Turkey;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Malaysia;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of

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

EUCTR2017-004605-41-GB
(EUCTR)

04/10/2018

04/06/2018

Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)

A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy - 021IGAN17001 (PROTECT) Sparsentan in IGAN

Immunoglobulin A Nephropathy (IgAN)
MedDRA version: 20.0;Level: PT;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: Sparsentan tablets/Overencapsulated Sparsentan tablets
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03
Product Name: Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN
Trade Name: Irbesartan tablets
Product Name: Irbesartan tablets
INN or Proposed INN: Irbesartan
Other descriptive name: Irbesartan
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN

Retrophin, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

380

Phase 3

United States;Portugal;Taiwan;Estonia;Hong Kong;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of

EUCTR2017-004605-41-ES
(EUCTR)

27/09/2018

30/07/2018

Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)

A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy

Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Trade Name: Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03
Product Name: over-encapsulated 150 mg Irbesartan Tablets
INN or Proposed INN: Irbesartan
Other descriptive name: IRBESARTAN

Retrophin, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 3

Portugal;United States;Estonia;Hong Kong;Spain;Lithuania;Turkey;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Malaysia;Belgium;Croatia;Australia;Germany;New Zealand;Korea, Republic of