Vadadustat for treating anemia in patients on hemodialysis
Safety of Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Hemodialysis Subjects: Vafseo Outcomes In-Center Experience
PHASE3 · USRC Kidney Research · NCT06520826
This study tests if a new medication called vadadustat can safely help people with anemia who are on hemodialysis feel better.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | USRC Kidney Research (network) |
| Locations | 5 sites (Lone Tree, Colorado and 4 other locations) |
| Trial ID | NCT06520826 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety of vadadustat, an erythropoiesis-stimulating agent, administered three times a week to patients with anemia of chronic kidney disease undergoing in-center hemodialysis. It is a multi-center, randomized, open-label study designed to gather long-term safety data from a large cohort of participants. The goal is to support the adoption of this dosing regimen in clinical practice for patients with end-stage kidney disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are receiving outpatient in-center hemodialysis at least three times per week.
Not a fit: Patients with contraindications to vadadustat or those who are not clinically stable may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for anemia in patients undergoing hemodialysis.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific dosing regimen is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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).
Where this trial is running
Lone Tree, Colorado and 4 other locations
- USRC Kidney Research — Lone Tree, Colorado, United States (RECRUITING)
- Nephrology and Hypertension Specialists, PC — Dalton, Georgia, United States (RECRUITING)
- US Renal Care - Gallup — Gallup, New Mexico, United States (RECRUITING)
- Dallas Renal Group — Dallas, Texas, United States (RECRUITING)
- US Renal Care - Live Oak — Live Oak, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Stephanie Brillhart, MSCI
- Email: stephanie.brillhart@usrenalcare.com
- Phone: 3038819451
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anemia of Chronic Kidney Disease