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 range18 Years
SexALL
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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 …
What they're measuring
1
Proportion of patients starting three times per week vadadustat (TIW-V) who remain on TIW-V at week 20