DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
66	IgA腎症	1

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-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-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