Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
Condition: Chronic Renal Failure; Chronic Kidney Disease; Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Anemia
Intervention: peginesatide; Epoetin Alfa
Intervention description: Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.; Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 803.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anemia; chronic kidney disease; CKD; chronic renal failure; CRF; dialysis; erythropoietin; EPO; erythropoiesis stimulating agent; ESA; Hematide™; hemodialysis; hemoglobin; Hb; Hgb; Omontys; peginesatide; red blood cell; red blood cell production

Summary:

      The purpose of the study was to evaluate the safety and efficacy of peginesatide in the
      maintenance treatment of anemia in participants on dialysis.
    

Eligibility criteria:

        Inclusion Criteria

          1. Participants with chronic renal failure on hemodialysis for ≥ 3 months prior to
             randomization.

          2. On intravenous epoetin alfa maintenance therapy continuously prescribed for a minimum
             of 8 weeks prior to randomization.

          3. Four consecutive hemoglobin values with a mean ≥ 10.0 and ≤ 12.0 g/dL during the
             screening period

        Exclusion Criteria

          1. Females who are pregnant or breast-feeding.

          2. Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule
             or to all parenteral iron supplementation products.

          3. Known bleeding or coagulation disorder.

          4. Known hematologic disease or cause of anemia other than renal disease

          5. Poorly controlled hypertension

          6. Evidence of active malignancy within one year prior to randomization.

          7. Temporary (untunneled) dialysis access catheter.

          8. A scheduled kidney transplant

          9. A scheduled surgery that may be expected to lead to significant blood loss.