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NCT02075463 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemodialysis-dependent Chronic Kidney Disease Subjects With Anemia
A Phase 2 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT02075463: Clinical Trial Phase 2 study, sponsored by GlaxoSmithKline.
NCT02075463 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02075463, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
The study will evaluate the ability of GSK1278863 to increase the hemoglobin (Hgb) concentration, or maintain it within the target range, and the safety and efficacy of GSK1278863 over 16 weeks of treatment, in hemodialysis-dependent subjects with anemia associated with chronic kidney disease who are chronically hyporesponsive to rhEPO. The data generated will inform dose requirements for any chronic rhEPO hyporesponsive hemodialysis-dependent subjects included in future clinical trials. The study consists of a 4-week rhEPO run-in period, a 16-week GSK1278863 treatment period and a 4-week Follow-up period.
Primary Outcome
Percentage of participants with increased Hgb \>=1 g/dL (if baseline Hgb is \<9.5 g/dL), or \>=0.5 g/dL (if baseline Hgb is 9.5-\<10 g/dL), or within the target range and not dropped by \>0.5 g/dL (if baseline Hgb is \>= 10 g/dL) at Week 16 are presented. Participants who were available at the indicated time point were analyzed
Interventions
- DRUG Placebo
- DRUG GSK1278863
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-06-01 |
| Est. Completion | 2016-03-16 |
| Phase | Phase 2 |
Why NCT02075463 stopped before completion
NCT02075463 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02075463 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02075463 about?
NCT02075463 is a clinical study titled "Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemodialysis-dependent Chronic Kidney Disease Subjects With Anemia". The study will evaluate the ability of GSK1278863 to increase the hemoglobin (Hgb) concentration, or maintain it within the target range, and the safety and efficacy of GSK1278863 over 16 weeks of treatment, in hemodialysis-dependent subjects with anemia associated with chronic kidney disease who ar...
What is the current status of trial NCT02075463?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2014-06-01. Estimated completion is 2016-03-16.
What interventions are being tested in trial NCT02075463?
The interventions under investigation include: Placebo (DRUG), GSK1278863 (DRUG).
Who is sponsoring clinical trial NCT02075463?
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 NCT02075463's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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