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Repeat Dose Safety and Efficacy Study for Compound to Treat Anemia

Kidney Disease Clinical Trial

Official title:
A Phase IIa, Randomized, Single-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of 28-day Repeat Oral Doses of GSK1278863A in Anemic Pre-dialysis and Hemodialysis-dependent Patients

Clinical Trial Summary

The purpose of this study is to characterize the safety and efficacy of repeat doses of compound 1278863A in subjects with anemia.

Clinical Trial Description

Compound 1278863A is a novel small molecule agent, which stimulates erythropoiesis through inhibition of hypoxia-inducible factor (HIF)-prolyl hydroxylases (EGLNs). This compound is being developed for the treatment of anemia. This study, PHI112844, will be the first administration of compound 1278863A to investigate the pharmacodynamics/efficacy, safety, tolerability, and pharmacokinetics of repeat oral doses in anemic pre-dialysis patients with moderate or severe renal impairment and in hemodialysis-dependent patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01047397
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 2
Start date March 2010
Completion date February 2011
View Details
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