A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)
Public ClinicalTrials.gov record NCT01977573. 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 24-week, Phase IIB, Randomized, Controlled, Parallel Group, Multi-center Study to Evaluate the Safety and Efficacy of GSK1278863 in Subjects With Anemia Associated With Chronic Kidney Diseases Who Are Not on Dialysis.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will be conducted in approximately 228 subjects with anemia associated with CKD who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1: recombinant human erythropoietin (rhEPO) naive subjects; Group 2: rhEPO users, who are currently receiving rhEPO. Subjects who are rhEPO naive will be randomized to receive either GSK1278863 once daily (QD) or rhEPO in a 3:1 fashion; subjects who are receiving an rhEPO before enrolling (rhEPO users) will be randomized in a 1:1 fashion to GSK1278863 QD or to the control arm. For those randomized to the control arm, the decision around whether the subject requires rhEPO, the selection of the type of rhEPO (if needed) and the choice of rhEPO dose to achieve and maintain Hgb concentrations within the target range should be based on Investigator clinical judgment, with the historical rhEPO dose and the current Hgb value being considered. The study consists of a screening phase of at least 4 weeks, a 24-week treatment phase and a follow-up visit that will occur approximately 4 weeks after completing treatment. It is anticipated that the data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.
Study identification
- NCT ID
- NCT01977573
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 252 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- 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
- Oct 31, 2013 (Type not available)
- Primary completion
- May 1, 2015 (Actual)
- Completion
- Jun 15, 2015 (Actual)
- Last update posted
- Oct 12, 2018
2013 – 2015
United States locations
- U.S. sites
- 25
- U.S. states
- 12
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Peoria | Arizona | 85381 | — |
| GSK Investigational Site | Azusa | California | 91702 | — |
| GSK Investigational Site | La Mesa | California | 91942 | — |
| GSK Investigational Site | Laguna Hills | California | 92653 | — |
| GSK Investigational Site | Los Angeles | California | 90022 | — |
| GSK Investigational Site | Los Angeles | California | 90025 | — |
| GSK Investigational Site | San Diego | California | 92103 | — |
| GSK Investigational Site | San Dimas | California | 91773 | — |
| GSK Investigational Site | West Hills | California | 91307 | — |
| GSK Investigational Site | Lauderdale Lakes | Florida | 33313 | — |
| GSK Investigational Site | Miami | Florida | 33150 | — |
| GSK Investigational Site | Pembroke Pines | Florida | 33028 | — |
| GSK Investigational Site | Macon | Georgia | 31217 | — |
| GSK Investigational Site | Savannah | Georgia | 31406 | — |
| GSK Investigational Site | Evergreen Park | Illinois | 60805 | — |
| GSK Investigational Site | Shreveport | Louisiana | 71101 | — |
| GSK Investigational Site | Farmington | Missouri | 63640 | — |
| GSK Investigational Site | Charlotte | North Carolina | — | — |
| GSK Investigational Site | Bethlehem | Pennsylvania | 18017 | — |
| GSK Investigational Site | Uniontown | Pennsylvania | 15401 | — |
| GSK Investigational Site | Knoxville | Tennessee | 37923 | — |
| GSK Investigational Site | Corsicana | Texas | 75110 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
| GSK Investigational Site | Temple | Texas | 76508 | — |
| GSK Investigational Site | Salt Lake City | Utah | 84112 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 98 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01977573, 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 Oct 12, 2018 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01977573 live on ClinicalTrials.gov.