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

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

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.

This is a multi-center, single-arm, open-label study assessing the safety of a phased transition from Epogen to three times per week vadadustat (TIW-V) for the treatment of anemia in subjects receiving in-center hemodialysis.

Subjects who have signed an IRB-approved informed consent form and who meet all of the inclusion criteria and none of the exclusion criteria will simultaneously have their Epogen dose reduced by 50% and initiate 300 mg vadadustat TIW.

Subsequent dose modifications will occur in order to target a narrow hemoglobin range (10-11 g/dL). Patients will have their hemoglobin assessed every 2 weeks and will continue in the trial for up to 28 weeks.

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 or equal to 3 times in 30 days prior to Screening (excluding rescheduled dialysis treatments)
• Pregnant at time of consent (per subject self-report)