Peginesatide for Anemia in Chronic Hemodialysis Patients

Phase 2 Completed 165 enrolled Affymax

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple intravenous doses of peginesatide in participants with chronic kidney disease (CKD) who are on hemodialysis.

Timeline

Start: 2005-07
Primary completion: 2007-05
Completion: 2007-05

Publications

Besarab A, Zeig SN, Martin ER, Pergola PE, Whittier FC, Zabaneh RI, Schiller B, Mayo M, Francisco CA, Polu KR, Duliege AM. An open-label, sequential, dose-finding study of peginesatide for the maintenance treatment of anemia in chronic hemodialysis patients. BMC Nephrol. 2012 Aug 30;13:95. doi: 10.1186/1471-2369-13-95.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	peginesatide	Peptide	0.05 mg/kg	Intravenous
Subject	peginesatide	Peptide	0.075 mg/kg	Intravenous
Subject	peginesatide	Peptide	0.1 mg/kg	Intravenous
Subject	peginesatide	Peptide	0.15 mg/kg	Intravenous
Subject	peginesatide	Peptide	4 mg	Intravenous
Subject	peginesatide	Peptide	6 mg	Intravenous
Subject	peginesatide	Peptide	12 mg	Intravenous
Subject	peginesatide	Peptide	16 mg	Intravenous

Peginesatide for Anemia in Chronic Hemodialysis Patients

Summary

Timeline

Publications

Drugs

Indications