NCT06520826Active, not recruitingPhase 3
Vafseo Outcomes In-Center Experience
Safety of Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Hemodialysis Subjects: Vafseo Outcomes In-Center Experience
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
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 of anemia in in-center hemodialysis patients with End Stage Kidney Disease (ESKD). This study will obtain long-term safety data in a large sample of subjects receiving in-center hemodialysis to support adoption of three times per week vadadustat dosing.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 2200 (estimated)
- First submitted
- 22 Jul 2024
- Start date
- 20 Nov 2024
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- USRC Kidney Research
- Diseases
- Chronic kidney disease
- NCT number
- NCT06520826
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 2200
- From 20 Nov 2024 to the primary completion date, 30 Jun 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cirrhosis or active, acute liver disease. Concomitant use of any hypoxia-inducible factor prolyl-hydroxylases or OAT1/OAT3 inhibitors (probenacid, rifampicin, gemfibrozil, or teriflunomide).
Other
- Contraindication to receive vadadustat or any of its known constituents per USPI.
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dallas Renal Group Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Nephrology and Hypertension Specialists, PC Coordinator of this site? Confirm its status | Dalton | United States | Unknown status |
| US Renal Care - Gallup Coordinator of this site? Confirm its status | Gallup | United States | Unknown status |
| US Renal Care - Live Oak Coordinator of this site? Confirm its status | Live Oak | United States | Unknown status |
| USRC Kidney Research Coordinator of this site? Confirm its status | Lone Tree | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.