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
283	後天性赤芽球癆	2

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	NCT00314795 (ClinicalTrials.gov)	April 6, 2006	13/4/2006	Efficacy and Safety of Peginesatide (AF37702) in the Treatment of Anemia in Participants With Chronic Kidney Disease	An Open-Label Study to Investigate the Efficacy and Safety of AF37702 Injection in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients With Chronic Kidney Disease	Anemia;Chronic Kidney Disease;Chronic Renal Failure;Pure Red Cell Aplasia	Drug: Peginesatide	Takeda	NULL	Completed	18 Years	N/A	All	22	Phase 2	France;Germany;United Kingdom
2	EUCTR2005-004944-30-DE (EUCTR)	08/03/2006	20/12/2005	A Phase 2 study of AF37702 Injection for anemia in patients with pure red cell aplasia.	An Open-Label Study to Investigate the Efficacy and Safety of AF37702 Injection (Hematide™) in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients with Chronic Kidney Disease - AFX01-06	Anemia caused by Antibody-Mediated Pure Red Cell Aplasia in Patients with Chronic Kidney Disease MedDRA version: 18.0;Level: PT;Classification code 10002965;Term: Aplasia pure red cell;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: AF37702 Injection Product Code: AF37702, Hematide INN or Proposed INN: peginesatide Other descriptive name: Hematide, peginesatide Product Name: AF37702 Injection Product Code: AF37702, Hematide INN or Proposed INN: peginesatide Other descriptive name: Hematide, peginesatide	Takeda Development Centre Europe Ltd	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Germany;United Kingdom

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

NCT00314795
(ClinicalTrials.gov)

April 6, 2006

13/4/2006

Efficacy and Safety of Peginesatide (AF37702) in the Treatment of Anemia in Participants With Chronic Kidney Disease

An Open-Label Study to Investigate the Efficacy and Safety of AF37702 Injection in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients With Chronic Kidney Disease

Anemia;Chronic Kidney Disease;Chronic Renal Failure;Pure Red Cell Aplasia

Drug: Peginesatide

Takeda

NULL

Completed

18 Years

N/A

All

Phase 2

France;Germany;United Kingdom

EUCTR2005-004944-30-DE
(EUCTR)

08/03/2006

20/12/2005

A Phase 2 study of AF37702 Injection for anemia in patients with pure red cell aplasia.

An Open-Label Study to Investigate the Efficacy and Safety of AF37702 Injection (Hematide™) in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients with Chronic Kidney Disease - AFX01-06

Anemia caused by Antibody-Mediated Pure Red Cell Aplasia in Patients with Chronic Kidney Disease
MedDRA version: 18.0;Level: PT;Classification code 10002965;Term: Aplasia pure red cell;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Product Name: AF37702 Injection
Product Code: AF37702, Hematide
INN or Proposed INN: peginesatide
Other descriptive name: Hematide, peginesatide
Product Name: AF37702 Injection
Product Code: AF37702, Hematide
INN or Proposed INN: peginesatide
Other descriptive name: Hematide, peginesatide

Takeda Development Centre Europe Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Germany;United Kingdom