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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
184
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.
Research Facility
Sacramento, California, United States
Research Facility
San Diego, California, United States
Research Facility
San Jose, California, United States
Research Facility
North Brunswick, New Jersey, United States
Percentage of Participants Undergoing Conversion to Peginesatide Injection
Time frame: 6 months
Peginesatide Dosing
The starting dose, mean dose throughout the study, and mean dose during the last week of treatment of peginesatide.
Time frame: Month 6 - 12
Peginesatide Dose Deviations
Data collected by sponsor of study (Affymax), and sponsor did not provide aggregate summary data.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion
Time frame: 12 months
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Research Facility
San Antonio, Texas, United States