4 Week Switch Study in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease
Public ClinicalTrials.gov record NCT01587924. 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 Four-week, Phase IIa, Randomized, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Switching Subjects From a Stable Dose of Recombinant Human Erythropoietin to GSK1278863 in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a four-week, Phase IIa, randomized, active-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of switching subjects from stable rhEPO to GSK1278863 in approximately 68 hemodialysis-dependent subjects with anemia associated with chronic kidney disease. The study consists of a screening phase of 2 weeks, a 4-week treatment phase and a 2-week follow-up phase. The range of Hgb values for study eligibility is 9.5-12.0 g/dL and the subjects must have received the same rhEPO product with total weekly doses that varied by no more than 50% during the 4 weeks prior to the Screening visit (Week -1. This study aims to estimate the relationship between dose of GSK1278863 and Hgb response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease after switching from a stable maintenance dose of recombinant human erythropoetin (rhEPO).
Study identification
- NCT ID
- NCT01587924
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 80 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
- May 23, 2012 (Actual)
- Primary completion
- May 27, 2013 (Actual)
- Completion
- May 27, 2013 (Actual)
- Last update posted
- Nov 14, 2017
2012 – 2013
United States locations
- U.S. sites
- 42
- U.S. states
- 16
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Paragould | Arizona | 72450 | — |
| GSK Investigational Site | Tempe | Arizona | 85284 | — |
| GSK Investigational Site | Pine Bluff | Arkansas | 71603 | — |
| GSK Investigational Site | Azusa | California | 91702 | — |
| GSK Investigational Site | Bakersfield | California | 93308 | — |
| GSK Investigational Site | Bakersfield | California | 93309 | — |
| GSK Investigational Site | Los Angeles | California | 90022 | — |
| GSK Investigational Site | Los Angeles | California | 90025-4837 | — |
| GSK Investigational Site | Los Angeles | California | 90057 | — |
| GSK Investigational Site | Lynwood | California | 60262 | — |
| GSK Investigational Site | Orange | California | 92868 | — |
| GSK Investigational Site | Riverside | California | 92505 | — |
| GSK Investigational Site | West Hills | California | 91307 | — |
| GSK Investigational Site | Whittier | California | 90603 | — |
| GSK Investigational Site | Arvada | Colorado | 80002 | — |
| GSK Investigational Site | Denver | Colorado | 80230 | — |
| GSK Investigational Site | Westminster | Colorado | 80031 | — |
| GSK Investigational Site | Waterbury | Connecticut | 06708 | — |
| GSK Investigational Site | Coral Springs | Florida | 33071 | — |
| GSK Investigational Site | Miami | Florida | 33145 | — |
| GSK Investigational Site | Miami | Florida | 33150 | — |
| GSK Investigational Site | Pembroke Pines | Florida | 33028 | — |
| GSK Investigational Site | Spring Hill | Florida | 34608 | — |
| GSK Investigational Site | Macon | Georgia | 31217 | — |
| GSK Investigational Site | Gurnee | Illinois | 60031 | — |
| GSK Investigational Site | Bethesda | Maryland | 20814 | — |
| GSK Investigational Site | Detroit | Michigan | 48236 | — |
| GSK Investigational Site | Southgate | Michigan | 48195 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89106 | — |
| GSK Investigational Site | Brooklyn | New York | 11212 | — |
| GSK Investigational Site | Asheville | North Carolina | NC 28805 | — |
| GSK Investigational Site | Charlotte | North Carolina | — | — |
| GSK Investigational Site | Durham | North Carolina | 27704 | — |
| GSK Investigational Site | Winston-Salem | North Carolina | 27101 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73116 | — |
| GSK Investigational Site | Erie | Pennsylvania | 16507 | — |
| GSK Investigational Site | Arlington | Texas | 76011 | — |
| GSK Investigational Site | Greenville | Texas | 75402 | — |
| GSK Investigational Site | Houston | Texas | 77004 | — |
| GSK Investigational Site | Houston | Texas | 77091 | — |
| GSK Investigational Site | Killeen | Texas | TX 76543 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
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 20 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01587924, 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 Nov 14, 2017 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01587924 live on ClinicalTrials.gov.