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	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

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

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