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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peginesatide / 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.

Group Type EXPERIMENTAL

Peginesatide

Intervention Type DRUG

All participants will receive peginesatide for the first 24 weeks.

Epoetin alfa

Intervention Type DRUG

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

Interventions

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Peginesatide

All participants will receive peginesatide for the first 24 weeks.

Intervention Type DRUG

Epoetin alfa

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

Intervention Type DRUG

Other Intervention Names

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Omontys Epogen

Eligibility Criteria

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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