NCT01977482

Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia

A Phase IIB, Randomized, Blinded, Dose-ranging, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Dose Response Relationship of GSK1278863 Over the First 4 Weeks of Treatment and Evaluate the Safety and Efficacy of GSK1278863 Over 24 Weeks in Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Switch From Recombinant Human Erythropoietin

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This study is intended to evaluate the dose-response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks to maintain hemoglobin (Hgb) level in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD) who are switched from a stable dose of recombinant human erythropoietin (rhEPO). The data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.

Conditions

• Anaemia

Interventions

Type	Name	Description
DRUG	GSK1278863	Film coated tablets containing 1 mg, 2 mg, 5 mg, or 25 mg of GSK1278863
DRUG	Placebo	Matching placebo tablet for GSK1278863
DRUG	rhEPO	rhEPO will be procured from local market

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-02-01
• Completion: 2015-02-06
• First posted: 2013-11-06
• Last updated: 2018-06-08
• Results posted: 2017-02-14

Locations

107 sites across 16 countries: United States, Australia, Canada, Czechia, Denmark, France, Germany, Hungary, Japan, Norway, Poland, Russia, South Korea, Spain, Sweden, United Kingdom