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NCT03409107 · ClinicalTrials.gov registry record · Phase 3
Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 614
- Enrollment target
NCT03409107: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT03409107 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 614 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03409107, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 614 participants
- Enrollment target
Study Summary
The purpose of this multi-center study in non-dialysis participants with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.
Primary Outcome
Blood samples were collected at given time points from participants for hemoglobin measurements. Evaluation period hemoglobin value was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 24 to Week 28 inclusive). For the primary analysis, the missing post-Baseline hemoglobin values were imputed using pre-specified multiple imputations. Change from Baseline was defined as the average of post-randomization values duri
Interventions
- DRUG Placebo
- DRUG Daprodustat (GSK1278863)
- DRUG Iron therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 614 participants |
| Start Date | 2018-03-05 |
| Est. Completion | 2020-10-07 |
| Phase | Phase 3 |
What the finished NCT03409107 record still lists
NCT03409107 is an interventional study that assigns participants to a tested intervention. The registered 614 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 (20% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03409107 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03409107 about?
NCT03409107 is a clinical study titled "Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)". The purpose of this multi-center study in non-dialysis participants with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.
What is the current status of trial NCT03409107?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 614 participants. The study started on 2018-03-05. Estimated completion is 2020-10-07.
What interventions are being tested in trial NCT03409107?
The interventions under investigation include: Placebo (DRUG), Daprodustat (GSK1278863) (DRUG), Iron therapy (DRUG).
Who is sponsoring clinical trial NCT03409107?
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 NCT03409107's enrollment target sits among peer trials
614 593rd of 2000 higher than 1,403 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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