To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis (NCT06901505)
A Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy of Three Times Weekly Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis
🩺 Plain-English Summary (8th-Grade Level)
This is a multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the efficacy of vadadustat administered three times a week compared to standard of care erythropoiesis-stimulating agent for the treatment of anemia in in-center hemodialysis participants with end-stage kidney disease (ESKD). A subset of sites will participate in a red blood cell (RBC) sub-study where changes in the phenotype of RBCs in response to vadadustat treatment relative to methoxy polyethylene glycol-epoetin beta treatment in DD-CKD participants with anemia will be assessed. A separate informed consent form (ICF) will be signed by these participants who opt to be in the RBC sub-study. Of the 350 participants in the main study, approximately 28 participants will also be enrolled into the RBC sub-study. The total duration of the study is approximately 35 Weeks including screening and follow-up.
Who can join: Review the eligibility criteria below.
Location: DaVita Research Site — Montgomery, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (18 Sites)
- DaVita Research Site — Montgomery, Alabama
- DaVita Research Site — Hartford, Connecticut
- DaVita Research Site — Middlebury, Connecticut
- DaVita Research Site — Columbus, Georgia
- DaVita Research Site #1 — Minneapolis, Minnesota
- DaVita Research Site — Minneapolis, Minnesota
- DaVita Research Site — Henderson, Nevada
- DaVita Research Site — Las Vegas, Nevada
- DaVita Research Site #1 — El Paso, Texas
- DaVita Research Site — El Paso, Texas
- DaVita Research Site #1 — Houston, Texas
- DaVita Research Site — Houston, Texas
- DaVita Research Site #1 — San Antonio, Texas
- DaVita Research Site #2 — San Antonio, Texas
- DaVita Research Site — San Antonio, Texas
- DaVita Research Site — The Woodlands, Texas
- DaVita Research Site #1 — Norfolk, Virginia
- DaVita Research Site — Norfolk, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.