Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemodialysis-dependent Chronic Kidney Disease Subjects With Anemia
Public ClinicalTrials.gov record NCT02075463. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 16-week, Phase 2a, Single-arm, Multi-center, Open-label Study to Evaluate the Safety and Efficacy of GSK1278863 After Switching From Recombinant Human Erythropoietin (rhEPO), in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Are Chronically Hyporesponsive to rhEPO
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02075463
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 15 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 10, 2014
- Primary completion
- Mar 15, 2016
- Completion
- Mar 15, 2016
- Last update posted
- Aug 3, 2026
2014 – 2016
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Azusa | California | 91702 | — |
| GSK Investigational Site | Glendale | California | 91204 | — |
| GSK Investigational Site | Los Angeles | California | 90025 | — |
| GSK Investigational Site | Simi Valley | California | 93065 | — |
| GSK Investigational Site | Hollywood | Florida | 33024 | — |
| GSK Investigational Site | St Louis | Missouri | 63110 | — |
| GSK Investigational Site | Amherst | New York | 14226 | — |
| GSK Investigational Site | Bethlehem | Pennsylvania | 18017 | — |
| GSK Investigational Site | Knoxville | Tennessee | 37923 | — |
| GSK Investigational Site | Houston | Texas | 77004 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02075463, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 3, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02075463 live on ClinicalTrials.gov.