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

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.

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