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

Phase 3

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
peginesatide injection	Epoetin	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 \[PTP\]).
peginesatide injection	Peginesatide	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 \[PTP\]).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Undergoing Conversion to Peginesatide Injection	6 months

Secondary Outcome Measures

Name	Time	Method
Peginesatide Dosing	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	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	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	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	12 months