Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis (DIAMOND)
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|ClinicalTrials.gov Identifier: NCT01478971|
Recruitment Status : Completed
First Posted : November 24, 2011
Results First Posted : May 26, 2014
Last Update Posted : September 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Anemia||Drug: Epoetin Drug: Peginesatide||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||184 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3b Single-Arm, Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
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.
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
- Percentage of Participants Undergoing Conversion to Peginesatide Injection [ Time Frame: 6 months ]
- Peginesatide Dosing [ Time Frame: Month 6 - 12 ]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 ]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 ]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 ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|