Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD (EU)

PHASE2TerminatedINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

September 30, 2009

Study Completion Date

September 30, 2009

Conditions
Chronic Renal FailureChronic Kidney DiseaseAnemia
Interventions
DRUG

peginesatide

Participants received the same initial peginesatide dose via the same route, intravenously or subcutaneously, as was administered at the end of the previous peginesatide treatment study in which the participant was enrolled. The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. Each participant was to receive peginesatide as an injection administered once every 4 weeks for approximately 54 months in this trial.

DRUG

peginesatide

Participants received the same initial peginesatide dose via the same route, intravenously or subcutaneously, as was administered at the end of the previous peginesatide treatment study in which the participant was enrolled. The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. Each participant was to receive peginesatide as an injection administered once every 4 weeks for approximately 54 months in this trial.

Trial Locations (20)

4003

Research Facility, Plovdiv

5000

Research Facility, Veliko Tarnovo

5800

Research Facility, Pleven

7002

Research Facility, Rousse

8000

Research Facility, Burgas

9010

Research Facility, Varna

300736

Research Facility, Timișoara

310017

Research Facility, Arad

600114

Research Facility, Bacau

700506

Research Facility, Iași

15-540

Research Facility, Bialystok

40-027

Research Facility, Katowice

90-153

Research Facility, Lodz

014461

Research Facility, Bucharest

CR7 7YE

Research Facility, Croydon

DE22 3NE

Research Facility, Derby

E1 1BB

Research Facility, London

SES 9RS

Research Facility, London

SW17 0QT

Research Facility, London

SA6 6NL

Research Facility, Swansea

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Affymax

INDUSTRY