A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Empagliflozin Among Patients Initiating Hemodialysis for the Treatment of End-Stage Kidney Disease
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
A 12-week, phase II, randomized, double-blind, placebo-controlled, multi-center study to assess the safety, tolerability, and preliminary efficacy of empagliflozin versus placebo among patients initiating hemodialysis (n=60) for the treatment of end-stage kidney disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adults ≥18 years on maintenance hemodialysis (HD) with residual kidney function
• Thrice-weekly HD
• Willingness and capacity to provide informed consent
• For women of childbearing potential, a negative pregnancy test is required at screening
Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
David Charytan, MD, MSc
David.Charytan@nyulangone.org
617-935-1572
Backup
Zoe Rimler
Zoe.Rimler@nyulangone.org
212-263-2544
Time Frame
Start Date: 2024-01-31
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 60
Treatments
Experimental: Empagliflozin
Participants with end-stage kidney disease (ESRD) initiating hemodialysis will receive Empagliflozin 10 mg daily for 12 weeks.
Placebo_comparator: Placebo
Participants with ESRD initiating hemodialysis will receive Empagliflozin-matching placebo daily for 12 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Boehringer Ingelheim
Leads: NYU Langone Health