Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03400033 · ClinicalTrials.gov registry record · Phase 3
Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 407
- Enrollment target
NCT03400033 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 407 participants.
The verdict
NCT03400033, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 407 participants
- Enrollment target
Study Summary
This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.
Interventions
- DRUG Daprodustat tablets
- DRUG Matching placebo tablets
- DRUG Epoetin alfa vials
- DRUG Saline vials or bags
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 407 participants |
| Start Date | 2018-09-05 |
| Est. Completion | 2020-06-19 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03400033
The ClinicalTrials.gov registry entry for NCT03400033 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 407 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Daprodustat tablets is the first listed.
NCT03400033 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03400033 about?
NCT03400033 is a clinical study titled "Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)". This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week f...
What is the current status of trial NCT03400033?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 407 participants. The study started on 2018-09-05. Estimated completion is 2020-06-19.
What interventions are being tested in trial NCT03400033?
The interventions under investigation include: Daprodustat tablets (DRUG), Matching placebo tablets (DRUG), Epoetin alfa vials (DRUG), Saline vials or bags (DRUG).
Who is sponsoring clinical trial NCT03400033?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.