Phase 3
N=823
Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
Chronic Renal Failure · Chronic Kidney Disease · Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00597584 ↗Enrolled (actual)
823
Serious AEs
50.2%
Results posted
Jul 2012
Primary outcome: Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period — 11.20; 11.21; 11.13; 11.05 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- peginesatide (Drug); Epoetin alfa or Epoetin beta (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Affymax
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Hemoglobin Between Baseline and the Evaluation Period |
11.20; 11.21; 11.13; 11.05; -0.07; -0.17 | — |
| SECONDARY Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods |
0.077; 0.099 | — |
| SECONDARY Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL) |
0.635; 0.659 | — |
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
- Participants with chronic renal failure on hemodialysis for ≥ 3 months prior to randomization.
- On IV epoetin alfa or beta maintenance therapy continuously prescribed for a minimum of 8 weeks prior to randomization.
- Four consecutive hemoglobin values with a mean ≥ 10.0 and ≤ 12.0 g/dL during the Screening Period.
Exclusion Criteria
- Females who are pregnant or breast-feeding.
- Known intolerance to any erythropoiesis stimulating agent or pegylated molecule or to all parenteral iron supplementation products.
- Known bleeding or coagulation disorder.
- Known hematologic disease or cause of anemia other than renal disease
- Poorly controlled hypertension.
- Evidence of active malignancy within one year prior to randomization.
- Temporary (untunneled) dialysis access catheter.
- A scheduled kidney transplant.
- A scheduled surgery that may be expected to lead to significant blood loss.
Data sourced from ClinicalTrials.gov (NCT00597584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.