NCT06520826

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,200

participants targeted

Target at P75+ for phase_3

Timeline
2mo left

Started Nov 2024

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Nov 2024Jun 2026

First Submitted

Initial submission to the registry

July 22, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

November 20, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

July 22, 2024

Last Update Submit

March 6, 2026

Conditions

Anemia of Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Combination of the hierarchical endpoints of all-cause mortality and all-cause hospitalization.

    The hierarchical endpoints of all-cause mortality and all cause hospitalization will be analyzed by the win odds method with ranking all cause mortality more important than all cause hospitalization.

    18 months

Secondary Outcomes (2)

  • All-cause hospitalization

    18 months

  • All-cause mortality

    18 months

Study Arms (2)

Vadadustat

EXPERIMENTAL

Vadadustat, 300 mg tablets, administered orally three times per week

Drug: Vadadustat

Erythropoiesis-stimulating agent (ESA) - Standard of Care (SOC)

ACTIVE COMPARATOR

Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp) administered as per standard of care

Drug: Erythropoiesis Stimulating Agent

Interventions

Erythropoiesis Stimulating AgentDRUG

Standard of care erythropoiesis stimulating agent will be administered to maintain hemoglobin within a target range of 10-11 g/dL.

Also known as: Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp)
Erythropoiesis-stimulating agent (ESA) - Standard of Care (SOC)
VadadustatDRUG

A synthetic, orally bioavailable, small molecule being developed as an inhibitor of hypoxia-inducible factor prolyl-hydroxylases for the treatment of anemia associated with chronic kidney disease. Intervention to be administered to maintain hemoglobin within a target range of 10-11 g/dL.

Also known as: Vafseo
Vadadustat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

USRC Kidney Research

Lone Tree, Colorado, 80124, United States

Location

Nephrology and Hypertension Specialists, PC

Dalton, Georgia, 30720, United States

Location

US Renal Care - Gallup

Gallup, New Mexico, 87301, United States

Location

Dallas Renal Group

Dallas, Texas, 75230, United States

Location

US Renal Care - Live Oak

Live Oak, Texas, 78233, United States

Location

MeSH Terms

Interventions

vadadustatHematinicsEpoetin Alfacontinuous erythropoietin receptor activatorDarbepoetin alfa

Intervention Hierarchy (Ancestors)

Hematologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2024

First Posted

July 25, 2024

Study Start

November 20, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations

US(5)