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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: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT03400033 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 407 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood samples were collected from participants for hemoglobin measurements. Hemoglobin during the evaluation period was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis, the missing post-Baseline hemoglobin values were imputed using pre-specified multiple imputations. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, includin
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 |
What the finished NCT03400033 record still lists
NCT03400033 is an interventional study that assigns participants to a tested intervention. The registered 407 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 4 interventions - of which Daprodustat tablets is the first listed.
NCT03400033 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03400033's enrollment target sits among peer trials
407 913th of 2000 higher than 1,088 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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