drugset / Trial / NCT00598273
Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-10
- Primary completion
- 2009-03
- Completion
- 2010-02
Outcome
Met primary endpoint
paper In both studies and at both starting doses, peginesatide was noninferior to darbepoetin in increasing and maintaining hemoglobin levels. PMID 23343062 ↗
registry Peginesatide 0.04 mg/kg vs Darbepoetin Alfa; Least Squares Mean Difference 0.26 (97.5% CI 0.04 to 0.48) NCT00598273 ↗
Publications
- Results Macdougall IC, Provenzano R, Sharma A, Spinowitz BS, Schmidt RJ, Pergola PE, Zabaneh RI, Tong-Starksen S, Mayo MR, Tang H, Polu KR, Duliege AM, Fishbane S; PEARL Study Groups. Peginesatide for anemia in patients with chronic kidney disease not receiving dialysis. N Engl J Med. 2013 Jan 24;368(4):320-32. doi: 10.1056/NEJMoa1203166.
- Fishbane S, Schiller B, Locatelli F, Covic AC, Provenzano R, Wiecek A, Levin NW, Kaplan M, Macdougall IC, Francisco C, Mayo MR, Polu KR, Duliege AM, Besarab A; EMERALD Study Groups. Peginesatide in patients with anemia undergoing hemodialysis. N Engl J Med. 2013 Jan 24;368(4):307-19. doi: 10.1056/NEJMoa1203165.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | 0.75 ug/kg | Subcutaneous |
| Subject | peginesatide | Peptide | 0.025 mg/kg | Subcutaneous |
| Subject | peginesatide | Peptide | 0.04 mg/kg | Subcutaneous |