Phase 2
N=114
Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA
Anemia · Chronic Renal Failure · Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT00680043 ↗Enrolled (actual)
114
Serious AEs
15.8%
Results posted
May 2012
Primary outcome: Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period — 9.34; 9.20; 9.07; 11.45 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- peginesatide (Drug); Epoetin Alfa (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Affymax
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Hemoglobin Between Baseline and the Evaluation Period |
9.34; 9.20; 9.07; 11.45; 11.59; 11.49 | — |
| SECONDARY Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods |
0.026; 0.0; 0.0 | — |
| SECONDARY Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods |
0.923; 0.973; 1.0 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease who are on dialysis and are not taking any treatment to increase their red blood cell production.
Eligibility Criteria
Inclusion Criteria
- On hemodialysis for chronic renal failure for at least 2 weeks prior to randomization.
- Two consecutive hemoglobin values of ≥ 8.0 g/dL and < 11.0 g/dL within the 4 weeks prior to randomization.
Exclusion Criteria
- Females who are pregnant or breast-feeding.
- Prior treatment with an erythropoiesis stimulating agent (ESA) in the 12 weeks prior to randomization.
- Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.
- Known bleeding or coagulation disorder.
- Known hematologic disease or cause for anemia other than renal disease
- Poorly controlled hypertension.
- Evidence of active malignancy within one year.
- A scheduled kidney transplant.
Data sourced from ClinicalTrials.gov (NCT00680043). 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.