NCT01047397

Repeat Dose Safety and Efficacy Study for Compound to Treat Anemia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Kidney Disease

Interventions

Type	Name	Description
DRUG	1278863A	25mg, 50mg, 100mg
DRUG	Placebo	matching placebo

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2010-01-12
• Last updated: 2013-11-11

Locations

37 sites across 4 countries: Australia, India, New Zealand, Russia