Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Patients Receiving Hemodialysis

Phase 4

Terminated

• Conditions: Anemia
• Interventions: Drug: Peginesatide; Drug: Epoetin alfa

• Registration Number: NCT01737879
• Lead Sponsor: Amgen

Brief Summary

The purpose of this study is to evaluate whether hemodialysis patients on peginesatide can be converted to epoetin alfa by using a predefined conversion table while achieving a stable hemoglobin.

Detailed Description

This is a phase 4, multicenter, single-arm, open-label study designed to evaluate whether patients receiving hemodialysis and treated with peginesatide can be converted to epoetin alfa using a predefined conversion table while achieving stable hemoglobin. The study will be conducted in two phases. Hemodialysis patients treated with epoetin alfa 3 times a week (TIW) will first be converted to peginesatide administered every 4 weeks (Q4W). After 24 weeks, these participants will be converted back to epoetin alfa administered TIW for 32 weeks. The primary endpoint will be the mean hemoglobin during the last 8 weeks of the epoetin alfa period.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-11-28
• Study First Posted: 2012-11-30
• Primary Completion: 2013-03
• Study Completion: 2013-07
• Status Verified: 2014-03
• Results First Submitted: 2014-03-14
• Results First Submitted QC: 2014-03-14
• Last Update Submitted: 2014-03-14
• Results First Posted: 2014-04-21
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Receiving hemodialysis 3 times a week
• Receiving epoetin alfa IV 3 times a week
• Hemoglobin concentration ≥ 9.0 and ≤ 12.0 g/dL within 8 weeks of or during screening

Key

Exclusion Criteria

• Systemic hematologic disease
• Changes in Epoetin alfa dose by ≥ 50% within 8 weeks of or during screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peginesatide / Epoetin Alfa	Epoetin alfa	Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
Peginesatide / Epoetin Alfa	Peginesatide	Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.

Primary Outcome Measures

Name	Time	Method
Mean Hemoglobin Concentration During the Evaluation Period	Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).	The hemoglobin concentrations during the evaluation period after the conversion to epoetin alfa were to be averaged for each participant and then summarized over all participants.; No participant reached the evaluation period, therefore, the primary efficacy endpoint could not be evaluated.

Secondary Outcome Measures

Name	Time	Method
Peginesatide Dose by Visit	Baseline and Weeks 5, 9, 13, and 17
Hemoglobin Concentration by Visit	Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21
Mean Dose of Epoetin Alfa During the Evaluation Period	Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).	No participant reached the evaluation period, therefore, this endpoint could not be evaluated.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Chesapeake, Virginia, United States