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NCT03799627 · ClinicalTrials.gov registry record · Phase 2
Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa
A Phase 2 study, sponsored by Akebia Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 175
- Enrollment target
NCT03799627: Completed Phase 2 study, sponsored by Akebia Therapeutics.
NCT03799627 is a Phase 2 study that has completed, run by Akebia Therapeutics. The registered enrollment target is 175 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03799627, a Phase 2 study, has completed, sponsored by Akebia Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 175 participants
- Enrollment target
Study Summary
This is a Phase 2 open-label efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD) study to evaluate oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy.
Primary Outcome
Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1.
Interventions
- DRUG Epoetin Alfa
- DRUG Vadadustat
- DRUG Vadadustat TIW
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2019-01-31 |
| Est. Completion | 2020-07-15 |
| Phase | Phase 2 |
What the finished NCT03799627 record still lists
NCT03799627 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% higher).
The record links to 0 conditions, and to 3 interventions - of which Epoetin Alfa is the first listed.
NCT03799627 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03799627 about?
NCT03799627 is a clinical study titled "Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa". This is a Phase 2 open-label efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD) study to evaluate oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy.
What is the current status of trial NCT03799627?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 175 participants. The study started on 2019-01-31. Estimated completion is 2020-07-15.
What interventions are being tested in trial NCT03799627?
The interventions under investigation include: Epoetin Alfa (DRUG), Vadadustat (DRUG), Vadadustat TIW (DRUG).
Who is sponsoring clinical trial NCT03799627?
This trial is sponsored by Akebia Therapeutics, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03799627's enrollment target sits among peer trials
175 396th of 2000 higher than 1,605 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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