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NCT01235936 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia
A Phase 2 study of Anemia and Kidney Disease, sponsored by Akebia Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT01235936: Completed Phase 2 study of Anemia and Kidney Disease, sponsored by Akebia Therapeutics.
NCT01235936 is a Phase 2 study of Anemia and Kidney Disease that has completed, run by Akebia Therapeutics. The registered enrollment target is 10 participants, below the 427-participant average among 72 other Anemia trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01235936, a Phase 2 study of Anemia and Kidney Disease, has completed, sponsored by Akebia Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.
Primary Outcome
Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates that hemoglobin concentration increased.
Conditions Studied
Interventions
- DRUG AKB-6548
Study Locations (2)
Georgia
- - Augusta
Texas
- - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2010-10-21 |
| Est. Completion | 2011-05 |
| Phase | Phase 2 |
What the finished NCT01235936 record still lists
NCT01235936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 427-participant average among 72 other Anemia trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Anemia appearing as the primary indexed condition, and to 1 intervention - of which AKB-6548 is the first listed.
NCT01235936 reports a single indexed study location in Georgia, Texas.
Frequently Asked Questions
What is clinical trial NCT01235936 about?
NCT01235936 is a clinical study titled "Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia". The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.
What is the current status of trial NCT01235936?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2010-10-21. Estimated completion is 2011-05.
What conditions does trial NCT01235936 study?
This clinical trial studies the following conditions: Anemia, Kidney Disease.
What interventions are being tested in trial NCT01235936?
The interventions under investigation include: AKB-6548 (DRUG).
Who is sponsoring clinical trial NCT01235936?
This trial is sponsored by Akebia Therapeutics, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01235936 being conducted?
This trial has 2 study locations across Georgia, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01235936's enrollment target sits among peer trials
10 71st of 72 higher than 2 of 72 other Anemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anemia 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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