DDrare: Database of Drug Development for Rare Diseases

222. 一次性ネフローゼ症候群
［臨床試験数：234，薬物数：241（DrugBank：78），標的遺伝子数：59，標的パスウェイ数：185］

Searched query = "Primary nephrotic syndrome", "Minimal change nephrotic syndrome", "MCNS", "Membranous nephropathy", "Focal segmental glomerulosclerosis", "FSGS", "Membranoproliferative glomerulonephritis", "MPGN"
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 = 100 mg AP1189; ABATACEPT; ACH-0144471; ACTH; ACTHar; ALXN2040 (ACH-0144471); AP1189; APL-2; AVACOPAN; Abatacept; Acetaminophen; Acetate; Acid mycophenolic (Myfortic); Acthar; Acthar Gel; Adalimumab; Adalimumab (Humira); Adrenocorticotrophic hormone ACTH; Advagraf 0,5mg; Advagraf 1mg; Advagraf 5mg; Aldosterone; Aliskiren; Amoxicillin; Angiotensin; Angiotensin II; Apixaban; Apixaban 5 MG; Aprovel (150 mg); Aprovel 150 mg Tablets; Atorvastatin; Atrasentan; Avacopan; BELIMUMAB; BENLYSTA; BENLYSTA®; BENLYSTA® (belimumab); BMS-188667; Bardoxolone; Bardoxolone methyl; Bardoxolone methyl capsules; Basiliximab; Belimumab; Belimumab 10 mg; Benlysta; Benlysta (belimumab); Bleselumab; CCX140; CCX140-B; CCX168; CDX; CDX-1135; CXA-10; CYCLOPHOSPHAMIDE; Calcium; Chlorambucil; Ciclofosfamida; Ciclosporin; Clarithromycin; Conventional therapy; Corticosteroid; Corticotropin; CsA; CyA; Cyclophosphamide; Cyclophosphamide and steroids; Cyclosporin; Cyclosporin, low dose steroid; Cyclosporine; Cyclosporins; D-Galactose; Dacortín 2,5mg; Dacortín 30mg; Dacortín 5mg; Dalteparin; Danicopan; Danzhu Fuyuan Granule; Dapagliflozin; Daratumumab; Device: LIPOSORBER® LA-15; Device: LIPOSORBER® LA-15 System; Dexamethasone; Diphenhydramine; ECULIZUMAB; ENDOXAN BAXTER*50CPR RIV 50MG; Eculizumab; Eliquis; Enalapril; Endoxan; Evolocumab; Experimental (Non Immunosuppressive Symptomatic Treatment (NIST) and Rituximab); FCM; FG-3019; FK506; Filgotinib; Fluvastatin; Fragmin; Fresolimumab; GC1008; GFB-887; GSK1550188; GSK1550188 (Belimumab); GZ402669; Galactose; Genoxal; Gold; H.P. Acthar Gel; Hydroxychloroquine; INN not available yet; IRBESARTAN; Intravenous (i.v.) methylprednisolone 1000 mg, total 9; Intravenous injection; Irbesartan; Irbesartan tablets; Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03; Irbesartan tablets (NDC# 43547-0374-03 and NDC 43547-374-09, approved in the USA) Generic tablets distributed by Solco Healthcare US, LLC; Jianpixiaozhong particles and Wuse Dietotherapy; LA; LNP023; LT4; Lanraplenib; Lansoprazole; Lansoprazole, amoxicillin, clarithromycin; Lisinopril; Lisinopril, losartan, and atorvastatin; Losartan; Losartan Tablets & QingReMoShen Granule; Losmapimod; MABTHERA; MABTHERA*EV 1FL 50ML 500MG; MEDROL*10CPR DIV 4MG; METHYLPREDNISOLONE; MMF; MMF and Dexamethasone; MOR03087; MOR202; MP and CTX; MabThera; MabThera 100 mg concentrate for solution for infusion; MabThera 500 mg concentrate for solution for infusion; Medrol; Mesenchymal stem cells; Methylprednisolone; Methylprednisone; Mizoribine; Mycophenolate; Mycophenolate Mofetil; Mycophenolate Mofetil (MMF); Mycophenolate mofetil; Mycophenolate mofetil orally 1000 mg twice a day (BID); Mycophenolate mofetil, low dose steroid; Mycophenolate sodium; Mycophenolic acid; Mycophenolic sodium; Myfortic; Myfortic 180mg Tablets; Myfortic 360mg Tablets; Myfortic plus low-dose steroid; Narsoplimab; Neoral; OMS721 (narsoplimab); Obinutuzumab; Oral Cyclosporine; Orencia; Other: D5W; Other: Normal Saline; Over-encapsulated 75 mg Irbesartan Tablets; Over-encapsulated Irbesartan Tablets; PF-06730512; PREDNISOLONE; PREDNISOLONE ACETATE; PREDNISONE; Pegcetacoplan; Pentoxifylline; Perindopril; Pirfenidone; Ponticelli Regimen; Prednisolone; Prednisolone acetate; Prednisolone and chlorambucil; Prednisolone and mycophenolate mofetil; Prednisona; Prednisone; Prednisone 0,5 mg/kg orally on alternate days; Prednisone, FK506, MMF; Prednisone, ciclosporin and mycophenolate mofetil; Procedure: Plasma exchange; Procedure: Plasmapheresis; Prograf; Propagermanium; RE-021; RE-021 (Sparsentan); RITUXIMAB; RTX; Repository Corticotropin Injection; Rituximab; Rituximab Infusion; Rosiglitazone; Rosiglitazone (Avandia); SPARSENTAN; Sirolimus; Soliris; Solondo; Sparsentan; Sparsentan/Over-encapsulated Sparsentan tablet; Sparsentan/Over-encapsulated Sparsentan tablets; Steroid & Cyclosporin; Sulfate; Symptomatic treatment (Converting Enzyme inhibitor, Angiotensin II, Anti-renin, Aldosterone antagonist diuretic, Beta blocker, Calcium inhibitor, statin); Synacthen Depot; Synacthen Depot 1mg; TACROLIMUS; TRU-015; TRUXIMA; TRUXIMAB; TW; Tacrolimus; Tacrolimus Capsules; Tacrolimus combined with prednisone; Tetracosactide; Tetracosactide hexacetaat; The Comprehensive Treatment Regimen of Traditional Chinese Medicine; The immunosuppressive agents; Tripterygium; Tripterygium Wilfordii; Tripterygium wilfordii; Tripterygium wilfordii (TW); Truxima; URBASON*IM EV 1F 250MG+1F 5ML; Urbason; VB119; VX-147; VX147; Valproic Acid; Valproic acid; Valsartan; Vitamin D; Voclosporin; Zestril; [CCX140-B];  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	NCT04456816 (ClinicalTrials.gov)	August 31, 2020	24/6/2020	A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN	An Exploratory, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AP1189 Versus Placebo Administered for 4 Weeks as an add-on to Patients, in ACE Inhibitor or Angiotensin II Receptor Blocker Treatment, With Idiopathic Membranous Nephropathy	Idiopathic Membranous Nephropathy	Drug: 100 mg AP1189;Drug: Placebo	SynAct Pharma Aps	NULL	Recruiting	18 Years	85 Years	All	23	Phase 2	Denmark
2	EUCTR2020-000971-18-DK (EUCTR)	28/05/2020	04/04/2020	A double-blind study for patients with idiopathic membranous nephropathy in treatment with ACE inhibor or angiotensin II receptor blockers. The trial will take place in hospitals in Denmark and Belgium. To better assess the mechanism of action of AP1189, the compound is compared to an inactive substance (placebo).The purpose of the trial is to investigate the safety of the new drug, its tolerability, uptake, metabolism, distribution, and excretion in the body (pharmacokinetics) and its effect	An exploratory, randomized, double-blind, multicenter, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and efficacy of AP1189 daily doses versus placebo administered for 4 weeks as an add-on to patients, in ACE inhibitor or angiotensin II receptor blocker treatment, with idiopathic membranous nephropathy - SynAct-CS003	Idiopathic membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: PT;Classification code 10029164;Term: Nephrotic syndrome;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: AP1189 INN or Proposed INN: Not applicable	SynAct Pharma ApS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	18	Phase 2	Denmark

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

NCT04456816
(ClinicalTrials.gov)

August 31, 2020

24/6/2020

A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN

An Exploratory, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AP1189 Versus Placebo Administered for 4 Weeks as an add-on to Patients, in ACE Inhibitor or Angiotensin II Receptor Blocker Treatment, With Idiopathic Membranous Nephropathy

Idiopathic Membranous Nephropathy

Drug: 100 mg AP1189;Drug: Placebo

SynAct Pharma Aps

NULL

Recruiting

18 Years

85 Years

All

Phase 2

Denmark

EUCTR2020-000971-18-DK
(EUCTR)

28/05/2020

04/04/2020

A double-blind study for patients with idiopathic membranous nephropathy in treatment with ACE inhibor or angiotensin II receptor blockers. The trial will take place in hospitals in Denmark and Belgium. To better assess the mechanism of action of AP1189, the compound is compared to an inactive substance (placebo).The purpose of the trial is to investigate the safety of the new drug, its tolerability, uptake, metabolism, distribution, and excretion in the body (pharmacokinetics) and its effect

An exploratory, randomized, double-blind, multicenter, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and efficacy of AP1189 daily doses versus placebo administered for 4 weeks as an add-on to patients, in ACE inhibitor or angiotensin II receptor blocker treatment, with idiopathic membranous nephropathy - SynAct-CS003

Idiopathic membranous nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: PT;Classification code 10029164;Term: Nephrotic syndrome;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: AP1189
INN or Proposed INN: Not applicable

SynAct Pharma ApS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Denmark