NCT00109291

Safety of Single Doses of Peginesatide in Patients With Chronic Kidney Disease

A Phase 2a, Randomized, Double-blind, Placebo-controlled, Sequential Dose Escalation Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Patients With Chronic Kidney Disease Who Are Not on Dialysis and Who Have Not Had Prior Erythropoiesis Stimulating Agent (ESA) Treatment

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Affymax · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety profile of single intravenous (IV) dose levels of peginesatide in participants with chronic kidney disease(CKD) not on dialysis.

Detailed description

This was a Phase 2a, randomized, double-blind, placebo-controlled, sequential dose escalation study conducted at a single clinical center. The study was designed to evaluate up to 6 treatment cohorts of 9 participants with CKD not on dialysis in the first cohort and 5 participants in each subsequent cohort. In each treatment cohort, participants were randomly assigned to receive either a single dose of peginesatide (n=7 in the first cohort, n=4 in subsequent cohorts) or placebo (n=2 in the first cohort, n=1 in subsequent cohorts). Participants were followed for a minimum of 28 days.

Conditions

• Anemia
• Chronic Kidney Disease
• Chronic Renal Failure

Interventions

Type	Name	Description
DRUG	Placebo
DRUG	peginesatide

Timeline

• Start date: 2005-03-01
• Primary completion: 2006-02-01
• Completion: 2006-02-01
• First posted: 2005-04-27
• Last updated: 2012-12-21

Locations

1 site across 1 country: United Kingdom