Phase 3
N=490
Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
Chronic Renal Failure · Chronic Kidney Disease · Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00598273 ↗Enrolled (actual)
490
Serious AEs
45.5%
Results posted
Jul 2012
Primary outcome: Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period — 10.05; 9.95; 10.05; 11.47 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- peginesatide (Drug); Darbepoetin alfa (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Affymax
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Hemoglobin Between Baseline and the Evaluation Period |
10.05; 9.95; 10.05; 11.47; 11.61; 11.47 | — |
| SECONDARY Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods |
0.062; 0.073; 0.049 | — |
| SECONDARY Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods. |
0.932; 0.939; 0.939 | — |
Summary
The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA) treatment.
Eligibility Criteria
Inclusion Criteria
- Chronic renal failure with an estimated glomerular filtration rate < 60 milliliter per minute per 1.73m^2 and not expected to begin dialysis for at least 12 weeks.
- Two consecutive hemoglobin values ≥ 8.0 g/dL and < 11.0 g/dL within 4 weeks prior to randomization.
Exclusion Criteria
- Females who are pregnant or breast-feeding.
- Treatment with an ESA in the 12 weeks prior to randomization.
- Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.
- Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
- 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.
- A scheduled kidney transplant
Data sourced from ClinicalTrials.gov (NCT00598273). 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.