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

Phase 4TerminatedNCT01737879

Amgen41 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia

Interventions

PeginesatideDRUG

All participants will receive peginesatide for the first 24 weeks.

Epoetin alfaDRUG

All participants converted to epoetin alfa at week 25 for a total of 32 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key 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

Locations (23)

Research Site

Phoenix, Arizona, United States

Research Site

Outcomes

Primary Outcomes

Mean Hemoglobin Concentration During the Evaluation Period

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.

Time frame: Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).

Secondary Outcomes

Mean Dose of Epoetin Alfa During the Evaluation Period

No participant reached the evaluation period, therefore, this endpoint could not be evaluated.

Time frame: Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).

Hemoglobin Concentration by Visit

Time frame: Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21

Peginesatide Dose by Visit

Time frame: Baseline and Weeks 5, 9, 13, and 17

Data from ClinicalTrials.gov

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