Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD (EU)
Condition: Chronic Renal Failure; Chronic Kidney Disease; Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Anemia
Intervention: peginesatide; peginesatide
Intervention description: Participants received the same initial peginesatide dose via the same route, intravenously or subcutaneously, as was administered at the end of the previous peginesatide treatment study in which the participant was enrolled. The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. Each participant was to receive peginesatide as an injection administered once every 4 weeks for approximately 54 months in this trial.; Participants received the same initial peginesatide dose via the same route, intravenously or subcutaneously, as was administered at the end of the previous peginesatide treatment study in which the participant was enrolled. The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. Each participant was to receive peginesatide as an injection administered once every 4 weeks for approximately 54 months in this trial.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 114.0
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 long term safety and tolerability of
      peginesatide for the maintenance of hemoglobin in participants with chronic kidney disease
      (CKD) who had received at least 24 weeks of peginesatide treatment in an earlier study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is informed of the investigational nature of this study and has given
             written, informed consent in accordance with institutional, local, and national
             guidelines.

          -  Males or females ≥ 18 years of age.

          -  Premenopausal females (with the exception of those who are surgically sterile) must
             have a negative pregnancy test at screening; those who are sexually active must
             practice a highly effective method of birth control for at least 4 weeks prior to
             study drug administration, and must be willing to continue contraception until at
             least 4 weeks after the last dose of study drug.

          -  Participant who has received at least 24 weeks of peginesatide dosing in a previous
             Affymax-sponsored study.

          -  One hemoglobin value of ≥ 10.0 grams per deciliter (g/dL) in the 4 weeks prior to
             study drug administration.

        Exclusion Criteria:

          -  Known intolerance to peginesatide or pegylated products.

          -  History of antibodies to any erythropoiesis stimulating agent (ESA) or history of pure
             red cell aplasia (PRCA).

          -  High likelihood of early withdrawal or interruption of the study (e.g., participant
             suffers from any clinically significant medical disease or condition that may, in the
             Investigator's opinion, interfere with safety, assessment, or follow-up of the
             participant)

          -  Anticipated life expectancy < 18 months

          -  Receipt of any ESA other than peginesatide at any time after participant enrollment in
             the previous Affymax-sponsored study