Safety and Efficacy of Peginesatide Injection for the Maintenance of Anemia in Chronic Renal Failure Participants Who Are on Hemodialysis or Do Not Require Dialysis and Previously Treated With Darbepoetin Alfa.
Condition: Anemia
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Anemia
Intervention: Peginesatide
Intervention description: Peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Anemia; Drug Therapy; Hemodialysis; Kidney Failure

Summary:

      The purpose of this study is to determine the efficacy and safety of Peginesatide Injection
      for the maintenance of anemia in patients with chronic renal failure who are on hemodialysis
      or do not require dialysis and who were previously treated with Darbepoetin Alfa.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient was a man or woman 18 to 90 years of age, inclusive.

          2. The patient had CKD and met 1 of the following criteria:

               1. Had been on dialysis for ≥6 months prior to enrollment, or

               2. Had not yet begun dialysis (hemodialysis or peritoneal dialysis) and was not
                  anticipated to require initiation of dialysis during participation in the study.

          3. The patient was on stable darbepoetin alfa maintenance therapy (either SC or IV)
             continuously for a minimum of 8 weeks prior to enrollment.

          4. The patient had 4 consecutive Hb values with a mean ≥10.0 and ≤12.0 g/dL during
             screening period, with the difference between the mean of the first 2 consecutive Hb
             values and the mean of the last 2 consecutive values being ≤1.0 g/dL.

        Exclusion Criteria:

          1. The patient had known bleeding or coagulation disorder.

          2. The patient had known hematologic disease or cause of anemia other than renal disease
             (i.e., pure red cell aplasia, homozygous sickle-cell disease, thalassemia,
             multiplemyeloma, hemolytic anemia, and myelodysplastic syndrome).

          3. The patient had received a recent course of intensive iron replacement (i.e., more
             than 500 mg IV in the 28 days prior to enrollment).

          4. The patient had advanced chronic CKD defined by New York Heart Association Class III
             or IV.

          5. The patient had a known history of seizure disorder or received antiepileptic
             medication for a seizure disorder within 6 months prior to enrollment.

          6. The patient had a scheduled kidney transplant. Patients currently on a transplant
             waiting list were not excluded, unless there was an identified donor.