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NCT02260193 · ClinicalTrials.gov registry record · Phase 2
16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis
A Phase 2 study, sponsored by Akebia Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
NCT02260193: Completed Phase 2 study, sponsored by Akebia Therapeutics.
NCT02260193 is a Phase 2 study that has completed, run by Akebia Therapeutics. The registered enrollment target is 94 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02260193, a Phase 2 study, has completed, sponsored by Akebia Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with end stage renal disease undergoing chronic hemodialysis.
Primary Outcome
Change from pre-dose average was calculated by the mid-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits.
Interventions
- DRUG AKB-6548
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2014-09-10 |
| Est. Completion | 2015-07-22 |
| Phase | Phase 2 |
What the finished NCT02260193 record still lists
NCT02260193 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 1 intervention - of which AKB-6548 is the first listed.
NCT02260193 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02260193 about?
NCT02260193 is a clinical study titled "16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis". The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with end stage renal disease undergoing chronic hemodialysis.
What is the current status of trial NCT02260193?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2014-09-10. Estimated completion is 2015-07-22.
What interventions are being tested in trial NCT02260193?
The interventions under investigation include: AKB-6548 (DRUG).
Who is sponsoring clinical trial NCT02260193?
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 NCT02260193's enrollment target sits among peer trials
94 764th of 2000 higher than 1,235 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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