Efficacy and Safety of Peginesatide (AF37702) in the Treatment of Anemia in Participants With Chronic Kidney Disease
Condition: Anemia; Chronic Kidney Disease; Chronic Renal Failure; Pure Red Cell Aplasia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Anemia; Red-Cell Aplasia, Pure
Intervention: Peginesatide
Intervention description: Peginesatide injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug Therapy; pure red cell aplasia; PRCA; chronic kidney disease; CKD; chronic renal failure; CRF; anemia; erythropoietin; EPO; erythropoiesis stimulating agent; ESA; hemoglobin; Hb; Hgb; red blood cell; red blood cell production

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).
    

Eligibility 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.