Safety, PD & PK of Multiple Doses of Peginesatide for Anemia in Chronic Kidney Disease Patients

Phase 2 Completed 139 enrolled Affymax

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple subcutaneous injections of peginesatide in participants with chronic kidney disease (CKD) not on dialysis who had not received erythropoiesis stimulating agent (ESA) treatment.

Timeline

Start: 2005-09
Primary completion: 2007-11
Completion: 2007-11

Publications

Macdougall IC, Wiecek A, Tucker B, Yaqoob M, Mikhail A, Nowicki M, MacPhee I, Mysliwiec M, Smolenski O, Sulowicz W, Mayo M, Francisco C, Polu KR, Schatz PJ, Duliege AM. Dose-finding study of peginesatide for anemia correction in chronic kidney disease patients. Clin J Am Soc Nephrol. 2011 Nov;6(11):2579-86. doi: 10.2215/CJN.10831210. Epub 2011 Sep 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	peginesatide	Peptide	0.025 mg/kg	Subcutaneous
Subject	peginesatide	Peptide	0.0375 mg/kg	Subcutaneous
Subject	peginesatide	Peptide	0.05 mg/kg	Subcutaneous
Subject	peginesatide	Peptide	0.075 mg/kg	Subcutaneous
Subject	peginesatide	Peptide	3 mg	Subcutaneous
Subject	peginesatide	Peptide	4 mg	Subcutaneous

Safety, PD & PK of Multiple Doses of Peginesatide for Anemia in Chronic Kidney Disease Patients

Summary

Timeline

Publications

Drugs

Indications