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

Phase 3Not Yet RecruitingNCT07565701

Geoff Block100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Anemia Associated With Chronic Kidney Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Proportion of patients starting three times per week vadadustat (TIW-V) who remain on TIW-V at week 20

Time frame: 20 weeks

Secondary Outcomes

Proportion of patients starting three times per week vadadustat (TIW-V) who do not demonstrate a drop in Hgb >0.75 g/dL at any point from baseline to week 20

Time frame: 20 weeks

Proportion of patients starting three times per week vadadustat (TIW-V) who achieve a mean Hgb in a range of 9-11.5 g/dL during weeks 20-24

Time frame: weeks 20-24