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NCT04707768 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
A Phase 3 study, sponsored by Akebia Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 456
- Enrollment target
NCT04707768: Completed Phase 3 study, sponsored by Akebia Therapeutics.
NCT04707768 is a Phase 3 study that has completed, run by Akebia Therapeutics. The registered enrollment target is 456 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04707768, a Phase 3 study, has completed, sponsored by Akebia Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 456 participants
- Enrollment target
Study Summary
This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of anemia in hemodialysis participants.
Primary Outcome
The Baseline Hb was defined as the average of last 2 central laboratory Hb measurements of samples taken at or prior to the first dose. The average for the PEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 20 through 26. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Bas
Interventions
- DRUG Vadadustat
- DRUG Mircera®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 456 participants |
| Start Date | 2021-06-18 |
| Est. Completion | 2023-01-30 |
| Phase | Phase 3 |
What the finished NCT04707768 record still lists
NCT04707768 is an interventional study that assigns participants to a tested intervention. The registered 456 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 (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Vadadustat is the first listed.
NCT04707768 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04707768 about?
NCT04707768 is a clinical study titled "Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects". This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of anemia in hemodialysis participants.
What is the current status of trial NCT04707768?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 456 participants. The study started on 2021-06-18. Estimated completion is 2023-01-30.
What interventions are being tested in trial NCT04707768?
The interventions under investigation include: Vadadustat (DRUG), Mircera® (DRUG).
Who is sponsoring clinical trial NCT04707768?
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 NCT04707768's enrollment target sits among peer trials
456 827th of 2000 higher than 1,172 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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