CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 493 enrolled
Drug / intervention
peginesatide +2 moredrug
Likely dose
peginesatide 0.025 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00598442
NCT00598442Phase 3Completed
CompareCT.gov

AFX01-13: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Correction of Anemia in Patients With Chronic Renal Failure (CRF) Not on Dialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment

Affymax·interventional·Posted Jan 21, 2008·Updated Feb 12, 2013

In Brief

A Phase 3 clinical trial evaluating peginesatide and Darbepoetin alfa for Chronic Renal Failure and 2 related conditions. Completed, enrolled 493 participants across 64 sites in 10 countries.

Detailed Summary

The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA) treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Renal Failure, Chronic Kidney Disease, Anemia
CountriesBulgaria, Czechia, Germany, Hungary, Italy, Poland, Puerto Rico, Romania, United Kingdom, United States
CollaboratorsTakeda

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 21, 2008
Enrollment StartNov 1, 2007
Primary CompletionJul 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.4 years ago

Interventions

peginesatidedrug

Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).

peginesatidedrug

Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.

Darbepoetin alfadrug

Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.