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

Study Overview
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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.

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.

Official Title
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Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Subjects Receiving Hemodialysis

Conditions
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Anemia

Intervention / Treatment
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* Drug: Peginesatide
* Drug: Epoetin alfa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peginesatide / Epoetin Alfa<br>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. | Drug: Peginesatide<br>* All participants will receive peginesatide for the first 24 weeks.<br>* Other names: Omontys;Drug: Epoetin alfa<br>* All participants converted to epoetin alfa at week 25 for a total of 32 weeks<br>* Other names: Epogen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56). | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Chronic Kidney Disease, End Stage Renal Disease, erythropoiesis-stimulating agents, Hemodialysis, Hemoglobin