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NCT01381094 · ClinicalTrials.gov registry record · Phase 2
42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
A Phase 2 study, sponsored by Akebia Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 93
- Enrollment target
NCT01381094: Completed Phase 2 study, sponsored by Akebia Therapeutics.
NCT01381094 is a Phase 2 study that has completed, run by Akebia Therapeutics. The registered enrollment target is 93 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01381094, a Phase 2 study, has completed, sponsored by Akebia Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 93 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in pre-dialysis participants with anemia with repeat dosing for 42 days.
Primary Outcome
Absolute change from Baseline was calculated as the Week 6 (end of treatment) value minus the Baseline value. Baseline Hgb was defined as the average of the last two measurements obtained prior to dosing. If there was only one measurement prior to dosing, this measurement served as Baseline. A positive change from Baseline indicated that hemoglobin concentration increased.
Interventions
- DRUG Placebo
- DRUG AKB-6548
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2011-06-15 |
| Est. Completion | 2012-02-16 |
| Phase | Phase 2 |
What the finished NCT01381094 record still lists
NCT01381094 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01381094 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01381094 about?
NCT01381094 is a clinical study titled "42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia". The purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in pre-dialysis participants with anemia with repeat dosing for 42 days.
What is the current status of trial NCT01381094?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2011-06-15. Estimated completion is 2012-02-16.
What interventions are being tested in trial NCT01381094?
The interventions under investigation include: Placebo (DRUG), AKB-6548 (DRUG).
Who is sponsoring clinical trial NCT01381094?
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 NCT01381094's enrollment target sits among peer trials
93 766th of 2000 higher than 1,234 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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