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 or Epoetin beta
Intervention description: Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.
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.; Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta 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: 823.0
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 this 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 IV epoetin alfa or beta 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 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.