Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis (DIAMOND)
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 3b Single-Arm, Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis|
- Proportion of subjects undergoing conversion to peginesatide injection [ Time Frame: 13 months ] [ Designated as safety issue: No ]
- Peginesatide injection dosing [ Time Frame: 13 months ] [ Designated as safety issue: No ]Dosing is based on mean dose of Epogen or Peginesatide throughout the study
- Peginesatide dose deviations [ Time Frame: 13 months ] [ Designated as safety issue: No ]Based on pre-specified dosing criteria
- Hemoglobin levels [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]Percentage of subjects with Hgb values within the Hgb range of 10-11 g/dl
- Iron Utilization [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]Total intravenous iron dose
- Red Blood Cell Transfusion [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]Percentage of subjects with red blood cell transfusions during the study
|Study Start Date:||September 2011|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
|Experimental: peginesatide injection||
Drug: peginesatide injection
Intervention is a once monthly IV or subcutaneous dose of peginesatide injection.
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 will be conducted at 1-5 hemodialysis sites in the United States, and will enroll Chronic Kidney Disease (CKD) patients receiving outpatient, in-center hemodialysis. The study treatment period is intended to be approximately 12 months in duration. Subjects will receive peginesatide injection for approximately six months.
|United States, California|
|Sacramento, California, United States, 95825|
|San Diego, California, United States, 91910|
|San Jose, California, United States, 95128|
|United States, New Jersey|
|North Brunswick, New Jersey, United States, 08902|
|United States, Texas|
|San Antonio, Texas, United States, 78215|
|Study Director:||Affymax, Inc.||Affymax, Inc.|