Safety of Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Hemodialysis Subjects: Vafseo Outcomes In-Center Experience

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Colorado
USRC Kidney Research
RECRUITING
Lone Tree
Georgia
Nephrology and Hypertension Specialists, PC
RECRUITING
Dalton
New Mexico
US Renal Care - Gallup
RECRUITING
Gallup
Texas
Dallas Renal Group
RECRUITING
Dallas
US Renal Care - Live Oak
RECRUITING
Live Oak
Contact Information
Primary
Stephanie Brillhart, MSCI
stephanie.brillhart@usrenalcare.com
3038819451
Backup
Martha Block, RN, CCRP
martha.block@usrenalcare.com
7205912533
Time Frame
Start Date: 2024-11-20
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 2200
Treatments
Experimental: Vadadustat
Vadadustat, 300 mg tablets, administered orally three times per week
Active_comparator: Erythropoiesis-stimulating agent (ESA) - Standard of Care (SOC)
Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp) administered as per standard of care
Related Therapeutic Areas
Sponsors
Collaborators: Akebia Therapeutics
Leads: USRC Kidney Research

This content was sourced from clinicaltrials.gov

Similar Clinical Trials