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 (VOTE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anemia Associated With Chronic Kidney Disease
• Intervention / Treatment: Drug: Epoetin alga (Epogen)/vadadustat

Detailed Description

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
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Martha Block; Email: martha.block@usrenalcare.com
• Study Contact Backup: Name: Stephanie Brillhart; Phone Number: 13038819451; Email: stephanie.brillhart@usrenalcare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phased transition from Epogen to three times weekly (TIW) oral vadadustat	Drug: Epoetin alga (Epogen)/vadadustat; Phased transition from Epogen to three times weekly (TIW) oral vadadustat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients starting three times per week vadadustat (TIW-V) who remain on TIW-V at week 20	20 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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	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	weeks 20-24

Collaborators and Investigators

• Sponsor: Geoff Block
• Collaborators: Akebia Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: USRC-2026-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No