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|
- Percentage of Participants Undergoing Conversion to Peginesatide Injection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Peginesatide Dosing [ Time Frame: Month 6 - 12 ] [ Designated as safety issue: No ]The starting dose, mean dose throughout the study, and mean dose during the last week of treatment of peginesatide.
- Peginesatide Dose Deviations [ Time Frame: Months 6 - 12 ] [ Designated as safety issue: No ]Data collected by sponsor of study (Affymax), and sponsor did not provide aggregate summary data.
- Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL [ Time Frame: Months 1, 2, 3, 4, 5 and 6 of each treatment period ] [ Designated as safety issue: No ]Percentage of participants with hemoglobin values within the hemoglobin range of 10-11 g/dL.
- Percentage of Participants Who Received at Least One Intravenous Iron Dose [ Time Frame: 12 months ] [ Designated as safety issue: No ]Participants received iron supplementation during the study to prevent iron deficiency and to maintain iron stores.
- Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: peginesatide injection
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]).
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.Drug: Peginesatide
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.
Other Name: Omontys
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478971
|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:||Medical Director, Clinical Science||Takeda|