Vafseo Outcomes In-Center Experience

Phase 3

Recruiting

• Conditions: Anemia of Chronic Kidney Disease
• Interventions: Drug: Vadadustat; Drug: Erythropoiesis Stimulating Agent

• Registration Number: NCT06520826
• Lead Sponsor: USRC Kidney Research

Brief Summary

This trial is an investigator-initiated, multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the safety of vadadustat administered three times per week for the treatment of anemia in in-center hemodialysis patients with End Stage Kidney Disease (ESKD). This study will obtain long-term safety data in a large sample of subjects receiving in-center hemodialysis to support adoption of three times per week vadadustat dosing.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-25
• Study Start: 2024-11-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

• Adult patients greater than or equal to 18 years of age.
• Receiving outpatient in-center hemodialysis at least three times per week for end-stage kidney disease.
• Currently prescribed or eligible for erythropoiesis-stimulating agent based on approved facility policy
• Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.

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Exclusion Criteria

• Contraindication to receive vadadustat or any of its known constituents per USPI.
• Cirrhosis or active, acute liver disease. Concomitant use of any hypoxia-inducible factor prolyl-hydroxylases or OAT1/OAT3 inhibitors (probenacid, rifampicin, gemfibrozil, or teriflunomide).
• Unable to comply with study requirements or in the opinion of a healthcare provider or a member of the central study team, not clinically stable to participate in the study.
• Pregnant at time of consent (per subject self-report).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vadadustat	Vadadustat	Vadadustat, 300 mg tablets, administered orally three times per week
Erythropoiesis-stimulating agent (ESA) - Standard of Care (SOC)	Erythropoiesis Stimulating Agent	Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp) administered as per standard of care

Primary Outcome Measures

Name	Time	Method
All-cause mortality	18 months

Secondary Outcome Measures

Name	Time	Method
All-cause hospitalization	18 months

Trial Locations

Locations (5)

Nephrology and Hypertension Specialists, PC; 🇺🇸 Dalton, Georgia, United States

US Renal Care - Gallup; 🇺🇸 Gallup, New Mexico, United States

Dallas Renal Group; 🇺🇸 Dallas, Texas, United States

US Renal Care - Live Oak; 🇺🇸 Live Oak, Texas, United States

USRC Kidney Research; 🇺🇸 Lone Tree, Colorado, United States