At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 216 enrolled

Drug / intervention

GSK1278863 +2 moredrug

Likely dose

GSK1278863 1 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01977482

NCT01977482Phase 2Completed

Compare CT.gov

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

GlaxoSmithKline·interventional·Posted Nov 6, 2013·Updated Jun 8, 2018

In Brief

A Phase 2 clinical trial evaluating GSK1278863, Placebo, and 1 other intervention for Anaemia. Completed, enrolled 216 participants across 107 sites in 16 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAnaemia

CountriesAustralia, Canada, Czechia, Denmark, France, Germany, Hungary, Japan, Norway, Poland, Russia, South Korea, Spain, Sweden, United Kingdom, United States

Collaborators--

Timeline

Phase 2CompletedFinished

2014201520162017201820192020202120222023202420252026

Enrollment StartNov 2013

First PostedNov 2013

Primary CompletionFeb 2015

Study CompletionFeb 2015

TodayJul 2026

First PostedNov 6, 2013

Enrollment StartNov 1, 2013

Primary CompletionFeb 1, 2015

Study CompletionFeb 6, 2015

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 12.7 years ago

Interventions

GSK1278863drug

Film coated tablets containing 1 mg, 2 mg, 5 mg, or 25 mg of GSK1278863

Placebodrug

Matching placebo tablet for GSK1278863

rhEPOdrug

rhEPO will be procured from local market