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NCT01977482 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 216
- Enrollment target
NCT01977482: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT01977482 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 216 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01977482, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 216 participants
- Enrollment target
Study 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.
Primary Outcome
Baseline Hgb value was the average of three Hgb values taken during screening period at Week (W) -4, W-2 and Day 1. Change from Baseline in Hgb was calculated as W4 value minus the Baseline value. To model the dose-response relationship a four-parameter Emax model was used. The dose response dataset was based on all non-missing data collected up to W4. Participants (par.) who had a Week 2 Hgb measurement, but a missing Week 4 Hgb measurement were included with a change from Baseline at Week 4 va
Interventions
- DRUG Placebo
- DRUG GSK1278863
- DRUG rhEPO
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2013-11-01 |
| Est. Completion | 2015-02-06 |
| Phase | Phase 2 |
What the finished NCT01977482 record still lists
NCT01977482 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01977482 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01977482 about?
NCT01977482 is a clinical study titled "Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia". 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 ...
What is the current status of trial NCT01977482?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 216 participants. The study started on 2013-11-01. Estimated completion is 2015-02-06.
What interventions are being tested in trial NCT01977482?
The interventions under investigation include: Placebo (DRUG), GSK1278863 (DRUG), rhEPO (DRUG).
Who is sponsoring clinical trial NCT01977482?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01977482's enrollment target sits among peer trials
216 286th of 2000 higher than 1,712 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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