Efficacy and Safety of Peginesatide (AF37702) in the Treatment of Anemia in Participants With Chronic Kidney Disease

• Status: Completed
• Trial end date: 2016-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the ability of peginesatide (AF37702) to increase and maintain increased hemoglobin levels in participants with chronic kidney disease (CKD) (either not on dialysis, receiving regular hemodialysis or peritoneal dialysis, or following renal transplant) with confirmed antibody-mediated pure red cell aplasia (PRCA).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda

Criteria

Inclusion Criteria:

• Participants who have confirmed antibody-mediated Pure red cell aplasia (PRCA) are potentially eligible for enrollment into this study.

• Participants must be ≥ 18 years old at the time of consent.

• Erythropoiesis stimulating agents (ESAs) must be discontinued for a minimum of 1 month prior to screening.

• Participant requires periodic transfusions to maintain hemoglobin.

• Hemoglobin < 10 g/dL for at least 2 measurements or participant has received a transfusion within the past 4 weeks to achieve a hemoglobin > 10 g/dL.

• Confirmation that an anti-erythropoietin antibody sample was obtained for analysis by the central reference laboratory within 1 month prior to baseline.

• Participants can either be participants with chronic kidney disease not yet requiring renal replacement therapy (participants not on dialysis), those on regular hemodialysis or peritoneal dialysis, or following a renal transplant.

• Participants may or may not have previously been treated with immunosuppressive therapy.

• Pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening.

• Written informed consent must be obtained.

Exclusion Criteria:

• Participants already successfully on another erythropoietic agent.

• Abnormal bone marrow findings consistent with the diagnosis of myelodysplasia, a myeloproliferative disorder, hematologic malignancy or evidence of metastatic infiltration.

• Poorly controlled hypertension.

• Previous exposure to any investigational agent within 4 weeks prior to administration of study drug or planned receipt during the study period.

• High likelihood of early withdrawal or interruption of the study.

• Participants who refuse to give informed consent.

• Women who are pregnant, lactating or not using a medically approved birth control.

• Life expectancy <12 months.