NCT00228436

Safety, PD & PK of Multiple Doses of Peginesatide for Anemia in Chronic Kidney Disease Patients

A Phase 2, Open-label, Multi-center, Sequential Dose Finding Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Multiple Doses of Subcutaneously Administered Peginesatide in Chronic Kidney Disease Patients Not on Dialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Affymax · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple subcutaneous injections of peginesatide in participants with chronic kidney disease (CKD) not on dialysis who had not received erythropoiesis stimulating agent (ESA) treatment.

Detailed description

This was a Phase 2, dose finding study designed to evaluate peginesatide treatment of participants with CKD not on ESA treatment. The objective was to determine the range of doses of peginesatide administered subcutaneously once every 4 weeks (Q4W) that increased and maintained hemoglobin at 11 to 13 g/dL.

Conditions

• Anemia
• Chronic Kidney Disease
• Chronic Renal Failure

Interventions

Type	Name	Description
DRUG	peginesatide

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2005-09-29
• Last updated: 2012-12-21

Locations

13 sites across 2 countries: Poland, United Kingdom