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NCT03029247 · ClinicalTrials.gov registry record · Phase 2
Anemia Study in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Blood Pressure (ASCEND-BP)
A Phase 2 study of Anaemia, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
- 11
- Study locations
NCT03029247: Completed Phase 2 study of Anaemia, sponsored by GlaxoSmithKline.
NCT03029247 is a Phase 2 study of Anaemia that has completed, run by GlaxoSmithKline. The registered enrollment target is 105 participants, above the 41-participant average among 3 other Anaemia trials with a reported enrollment target (156% higher). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03029247, a Phase 2 study of Anaemia, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
- 11
- Study locations
Study Summary
This will be an open-label, randomized, parallel-group study in hemodialysis-dependent (HD) participants with anemia associated with chronic kidney disease (CKD), designed to compare the effects of daprodustat to epoetin alfa on blood pressure (BP). Participants will be screened for eligibility within 7 and 30 days prior to erythropoesis-stimulating agent (ESA) washout. Following a 2-week ESA washout period, on Day 1 participants will be randomized 1:1 and stratified by prior ESA dose before they undergo Acute Challenge 1, a single dose challenge to compare the acute effects on BP of the highest planned once-daily maintenance dose of daprodustat (24 milligrams \[mg\]) to the highest starting dose of epoetin alfa (100 units/kilogram \[U/kg\]). This will be followed by an 8-week hemoglobin (Hgb)-maintenance period, where doses of either daprodustat or epoetin alfa will be administered and adjusted. At the end of Hgb maintenance period, on Day 57 an Acute Challenge 2 will be repeated utilizing the same treatment dose administered in Acute Challenge 1; there will be a follow-up visit within 14+/-3 days after completing treatment.
Primary Outcome
The effect of daprodustat and epoetin alfa on blood pressure was compared using ABPM after 8 weeks of Hgb maintenace therapy on Day 57. Analysis was based on "analysis of covariance (ANCOVA) with terms for treatment, prior erythropoiesis-stimulating agent (ESA) dose (low/high), post-Hemodialysis dependent (HD)/pre-AC 1 SBP, difference between post-HD/pre-AC 2 SBP and post-HD/pre-AC 1 SBP and treatment by difference in post-HD SBP between AC 1 and 2 interaction." Least square (LS) mean of 6 hour
Conditions Studied
Interventions
- DRUG Epoetin alfa
- DRUG Daprodustat
Study Locations (11)
Florida
- GSK Investigational Site - Coral Gables
- GSK Investigational Site - DeLand
- GSK Investigational Site - Hollywood
- GSK Investigational Site - Miami
- GSK Investigational Site - Orlando
California
- GSK Investigational Site - La Mesa
Colorado
- GSK Investigational Site - Lakewood
Illinois
- GSK Investigational Site - Chicago
Minnesota
- GSK Investigational Site - Minneapolis
South Carolina
- GSK Investigational Site - Spartanburg
Texas
- GSK Investigational Site - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2017-07-27 |
| Est. Completion | 2020-07-09 |
| Phase | Phase 2 |
What the finished NCT03029247 record still lists
NCT03029247 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, above the 41-participant average among 3 other Anaemia trials with a reported enrollment target (156% higher).
The record links to 1 condition, with Anaemia appearing as the primary indexed condition, and to 2 interventions - of which Epoetin alfa is the first listed.
NCT03029247 lists 11 locations in 7 states (Florida, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT03029247 about?
NCT03029247 is a clinical study titled "Anemia Study in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Blood Pressure (ASCEND-BP)". This will be an open-label, randomized, parallel-group study in hemodialysis-dependent (HD) participants with anemia associated with chronic kidney disease (CKD), designed to compare the effects of daprodustat to epoetin alfa on blood pressure (BP). Participants will be screened for eligibility with...
What is the current status of trial NCT03029247?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2017-07-27. Estimated completion is 2020-07-09.
What conditions does trial NCT03029247 study?
This clinical trial studies the following conditions: Anaemia.
What interventions are being tested in trial NCT03029247?
The interventions under investigation include: Epoetin alfa (DRUG), Daprodustat (DRUG).
Who is sponsoring clinical trial NCT03029247?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03029247 being conducted?
This trial has 11 study locations across California, Colorado, Florida, Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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