Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis

Study Overview
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Brief Summary
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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.

Detailed Description
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Monthly Erythropoiesis-Stimulating Agents (ESA) dosing, compared with the longstanding practice of dosing three times per week, represents a significant change in anemia treatment for dialysis patients. Because of the differences in the processes needed to support monthly dosing versus thrice weekly dosing, there is a need to prospectively identify and evaluate factors in the dialysis environment during center-level transition of patients from one ESA to another. AFX01-18 is a Phase 3b open-label, single-arm conversion study that was conducted at 5 hemodialysis sites in the United States, and enrolled Chronic Kidney Disease (CKD) patients receiving outpatient, in-center hemodialysis. The study treatment period was approximately 12 months in duration. Participants received peginesatide injection for approximately six months.

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

Conditions
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Chronic Kidney Disease, Anemia

Intervention / Treatment
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* Drug: Epoetin
* Drug: Peginesatide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have provided written informed consent in accordance with institutional, local, and national guidelines Are ≥18 years of age at the start of screening Have been on in-center hemodialysis for ≥12 weeks at the start of screening Are currently maintained on Epoetin at the start of screening If sexually active and a female of childbearing potential, are willing to use highly effective method of birth control ≥4 weeks before study enrollment and through the study If a female of childbearing potential, have a negative pregnancy test during screening Exclusion Criteria: Are scheduled for a renal transplantation during study (Note: patients awaiting transplantation with no date scheduled may enroll.) Have an active malignancy or malignancy treated within one year prior to the start of screening for curative or palliative intent (Note: patients with non-melanoma skin cancers may enroll.) Have known intolerance to any ESA or PEGylated molecule Have been exposed to any investigational agent during the four weeks prior to the start of screening or are anticipated to receive such agents during the study Have any significant medical or psychiatric condition judged by the investigator to prevent informed consent or study compliance Are pregnant or nursing

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 injection<br>In the first 6 months participants received standard of care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1-week erythropoiesis-stimulating agent (ESA)-Free Period, followed by peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]). | Drug: Epoetin<br>* 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.<br>Drug: Peginesatide<br>* 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.<br>* Other names: Omontys;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Undergoing Conversion to Peginesatide Injection |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peginesatide Dosing | The starting dose, mean dose throughout the study, and mean dose during the last week of treatment of peginesatide. | Month 6 - 12 | 
| Peginesatide Dose Deviations | Data collected by sponsor of study (Affymax), and sponsor did not provide aggregate summary data. | Months 6 - 12 | 
| Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL | Percentage of participants with hemoglobin values within the hemoglobin range of 10-11 g/dL. | Months 1, 2, 3, 4, 5 and 6 of each treatment period | 
| Percentage of Participants Who Received at Least One Intravenous Iron Dose | Participants received iron supplementation during the study to prevent iron deficiency and to maintain iron stores. | 12 months | 
| Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Chronic Renal Failure, CRF, Chronic Kidney Disease, CKD, Erythropoietin, Hematide, Peginesatide, Hemoglobin, Hgb, Red Blood Cell, Red Blood Cell Production, Dialysis