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NCT03799848 · ClinicalTrials.gov registry record · Phase 1
A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function
A Phase 1 study of Hepatic Impairment, sponsored by Akebia Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT03799848: Completed Phase 1 study of Hepatic Impairment, sponsored by Akebia Therapeutics.
NCT03799848 is a Phase 1 study of Hepatic Impairment that has completed, run by Akebia Therapeutics. The registered enrollment target is 24 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (33% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03799848, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Akebia Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a Phase I open-label study to evaluate the pharmacokinetic (PK) profile of a single oral dose of vadadustat in subjects with hepatic impairment(HI) compared to healthy matched control subjects with normal hepatic function.
Conditions Studied
Interventions
- DRUG Vadadustat
Study Locations (2)
Minnesota
- Prism Clinical Research - Saint Paul
Texas
- American Research Corporation at the University of Texas Liver Institute - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-06-12 |
| Est. Completion | 2018-10-18 |
| Phase | Phase 1 |
What the finished NCT03799848 record still lists
NCT03799848 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (33% lower).
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which Vadadustat is the first listed.
NCT03799848 reports a single indexed study location in Minnesota, Texas.
Frequently Asked Questions
What is clinical trial NCT03799848 about?
NCT03799848 is a clinical study titled "A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function". This is a Phase I open-label study to evaluate the pharmacokinetic (PK) profile of a single oral dose of vadadustat in subjects with hepatic impairment(HI) compared to healthy matched control subjects with normal hepatic function.
What is the current status of trial NCT03799848?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-06-12. Estimated completion is 2018-10-18.
What conditions does trial NCT03799848 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT03799848?
The interventions under investigation include: Vadadustat (DRUG).
Who is sponsoring clinical trial NCT03799848?
This trial is sponsored by Akebia Therapeutics, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03799848 being conducted?
This trial has 2 study locations across Minnesota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatic Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03799848's enrollment target sits among peer trials
24 33rd of 48 higher than 11 of 48 other Hepatic Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Impairment 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.
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