CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 184 enrolled
Drug / intervention
Epoetin +1 moredrug
Likely dose
Epoetin 11 gfrom 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/NCT01478971
NCT01478971Phase 3Completed
CompareCT.gov

A Phase 3b Single-Arm, Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis

Takeda·interventional·Posted Nov 24, 2011·Updated Sep 20, 2016

In Brief

A Phase 3 clinical trial evaluating Epoetin and Peginesatide for Chronic Kidney Disease and Anemia. Completed, enrolled 184 participants across 5 sites.

Detailed Summary

The purpose of this study is to understand the effects of a dialysis center switching its dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and other parameters.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease, Anemia
CountriesUnited States
CollaboratorsAffymax

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 24, 2011
Enrollment StartOct 1, 2011
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.6 years ago

Interventions

Epoetindrug

Commercially available epoetin alfa administered weekly, twice weekly, or thrice weekly at an initial starting dose, frequency of administration, and mode of administration (intravenous \[IV\] or subcutaneous \[SC\]) individually determined for each participant using the site's usual standard of care. Subsequent dose adjustments or dose holds may have been made in order to maintain a hemoglobin concentration of \<11 g/dL.

Peginesatidedrug

Administered as a once monthly intravenous (IV) or subcutaneous (SC) injection. The initial dose of peginesatide injection was based on the final weekly dose of epoetin administered in the SCP; subsequent doses may have been adjusted in order to maintain hemoglobin concentrations at \<11 g/dL.