Status:
RECRUITING
Vafseo Outcomes In-Center Experience
Lead Sponsor:
USRC Kidney Research
Collaborating Sponsors:
Akebia Therapeutics
Conditions:
Anemia of Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This trial is an investigator-initiated, multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the safety of vadadustat administered three times per week for the treatment ...
Eligibility Criteria
Inclusion
- Adult patients greater than or equal to 18 years of age.
- Receiving outpatient in-center hemodialysis at least three times per week for end-stage kidney disease.
- Currently prescribed or eligible for erythropoiesis-stimulating agent based on approved facility policy
- Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
Exclusion
- Contraindication to receive vadadustat or any of its known constituents per USPI.
- Cirrhosis or active, acute liver disease. Concomitant use of any hypoxia-inducible factor prolyl-hydroxylases or OAT1/OAT3 inhibitors (probenacid, rifampicin, gemfibrozil, or teriflunomide).
- Unable to comply with study requirements or in the opinion of a healthcare provider or a member of the central study team, not clinically stable to participate in the study.
- Pregnant at time of consent (per subject self-report).
Key Trial Info
Start Date :
November 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
2200 Patients enrolled
Trial Details
Trial ID
NCT06520826
Start Date
November 20 2024
End Date
June 30 2026
Last Update
December 11 2024
Active Locations (5)
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1
USRC Kidney Research
Lone Tree, Colorado, United States, 80124
2
Nephrology and Hypertension Specialists, PC
Dalton, Georgia, United States, 30720
3
US Renal Care - Gallup
Gallup, New Mexico, United States, 87301
4
Dallas Renal Group
Dallas, Texas, United States, 75230