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

NCT07565701 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: USRC-2026-001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anemia Associated With Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

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

  20 weeks

Secondary Outcomes (2)

• 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

Study Arms (1)

Phased transition from Epogen to three times weekly (TIW) oral vadadustat

EXPERIMENTAL

Drug: Epoetin alga (Epogen)/vadadustat

Interventions

Epoetin alga (Epogen)/vadadustat DRUG

Phased transition from Epogen to three times weekly (TIW) oral vadadustat

Phased transition from Epogen to three times weekly (TIW) oral vadadustat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Geoff Block: lead
• Akebia Therapeutics Inc.: collaborator

Central Study Contacts

Stephanie Brillhart

CONTACT

13038819451; stephanie.brillhart@usrenalcare.com

Martha Block

CONTACT

martha.block@usrenalcare.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Vice President of Research and Associate Chief Medical Officer

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share