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Completed Phase 1 Interventional Accepts healthy volunteers

A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function

ClinicalTrials.gov ID: NCT03799848

Public ClinicalTrials.gov record NCT03799848. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 10:05 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase 1, Open-Label, Parallel-Group, Pharmacokinetic Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03799848
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Akebia Therapeutics
Industry
Enrollment
24 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 70 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 12, 2018 (Actual)
Primary completion
Oct 18, 2018 (Actual)
Completion
Oct 18, 2018 (Actual)
Last update posted
Mar 22, 2019

2018

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Prism Clinical Research Saint Paul Minnesota 55114 —
American Research Corporation at the University of Texas Liver Institute San Antonio Texas 78215 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03799848, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 22, 2019 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03799848 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →