Trials / Completed
CompletedNCT03992066
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease
A Phase 1b, Randomized, Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Akebia Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will be conducted to assess the pharmacokinetics of vadadustat 600, 750, and 900 milligrams daily, and intravenous erythropoiesis-stimulating agent (darbepoetin alfa or epoetin alfa), in hemodialysis participants with anemia associated with chronic kidney disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vadadustat | oral 150 mg tablet |
| DRUG | Darbepoetin alfa | solution intravenous injection |
| DRUG | Epoetin alfa | solution for intravenous injection |
Timeline
- Start date
- 2019-05-28
- Primary completion
- 2020-05-05
- Completion
- 2020-07-15
- First posted
- 2019-06-19
- Last updated
- 2020-09-16
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03992066. Inclusion in this directory is not an endorsement.