Safety and Efficacy of a Phased Transition From Epogen to Three Times Weekly Oral Vadadustat for … (NCT07565701) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Safety and Efficacy of a Phased Transition From Epogen to Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Subjects Receiving In-Center Hemodialysis
100 participantsStarted 2026-04
Plain-language summary
The goal of this study is to assess if patients can be retained on long-term vadadustat therapy (and thus potentially benefit from the favorable safety profile) by incorporating a phased transition from Epogen to three times per week vadadustat (TIW-V), reducing the likelihood of GI intolerance through use of a lower vadadustat starting dose, and also reducing or eliminating the initial reduction in hemoglobin through the maintenance of low dose Epogen until target hemoglobin stability is achieved on a tolerable dose of TIW-V.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients ≥18 years of age
* Receiving outpatient in-center hemodialysis for ESKD at least TIW (prescribed)
* Currently receiving EPO (active administration, not on HOLD)
* Less than or equal to 0.75 g/d difference between last 2 Hgb values prior to Screening, with neither Hgb \<9 g/dL
* Average of last 2 Hgb between 9-11.4 g/dL (inclusive) prior to Screening
* Central Screening Hgb 9-11.4 g/dL (inclusive)
* Central Screening transferrin saturation greater than or equal to 20%
* Central Screening serum ferritin greater than or equal to 100 ng/mL
* 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 per United States Prescribing Information (USPI) including Screening liver function tests greater than 3x the upper limit of normal (ULN)
* Electronic Medical Record (EMR)-documented history of cirrhosis or active, acute liver disease
* EMR-documented history of currently active malignancy excluding non-melanomatous skin cancer and in-situ cervical cancer
* Concomitant use of HIF-PHI or OAT1/OAT3 inhibitors (probenecid, rifampicin, gemfibrozil, or teriflunomide)
* Unable to comply with study requirements or in the opinion of a healthcare provider or member of the central study team, not clinically stable to participate in the study
* Documented unplanned absence from dialysis greater than …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients starting three times per week vadadustat (TIW-V) who remain on TIW-V at week 20