Evaluating empagliflozin for patients on hemodialysis
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
PHASE2 · NYU Langone Health · NCT05786443
This study is testing if a medication called empagliflozin can help people starting hemodialysis for kidney disease feel better and stay safe compared to a placebo.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health (other) |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05786443 on ClinicalTrials.gov |
What this trial studies
This is a 12-week, phase II, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and preliminary efficacy of empagliflozin compared to a placebo in patients who are starting hemodialysis due to end-stage kidney disease. The study will involve 60 participants who are on maintenance hemodialysis with some residual kidney function. Participants will be monitored for any adverse effects and improvements in their condition throughout the trial period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are on maintenance hemodialysis with residual kidney function.
Not a fit: Patients who are anuric, have planned kidney transplants, or have certain cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that improves outcomes for patients undergoing hemodialysis.
How similar studies have performed: While this approach is relatively novel in the context of hemodialysis, similar studies have shown promise in other populations with diabetes and renal issues.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Does not have capacity to consent * Anuria (daily urine volume \< 200 mL/day) * Planned kidney transplant within 3 months * Recurrent urinary tract infections (\>2 episodes/year or antibiotic prophylaxis) * New York Heart Association (NYHA) Class IV heart failure (HF) * Myocardial infarction, unstable angina, revascularization procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 12 weeks * History of diabetic ketoacidosis * Type 1 Diabetes Mellitus * Hereditary glucose-galactose malabsorption or primary renal glucosuria * Liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis); Alanine aminotransferase (ALT) levels \>2.0 times the upper limit of normal (ULN) or total bilirubin \>1.5 times the ULN, unless consistent with Gilbert's disease * Active malignancy (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ) defined as malignancy under active treatment with chemotherapy, radiation or immunotherapy, or being treated as palliative. * Major surgery within 12 weeks * Atraumatic amputation within past 12 months of screening, or an active skin ulcer, osteomyelitis, gangrene, or critical ischemia of the lower extremity within 6 months of screening * Combination use of angiotensin-converting enzyme inhibitor (ACEi) and angiotensin receptor blocker (ARB) * Current use of an SGLT2 inhibitor (within 6 weeks prior to randomization) * Known allergies, hypersensitivity, or intolerance to SGLT2i or its excipients * Received an active investigational drug (including vaccines) other than a placebo agent, or used an investigational medical device within 12 weeks before Day 1/baseline * Pregnant or breast-feeding or planning to become pregnant or breast-feed during the study * Women of childbearing potential not willing to use a highly-effective method(s) of birth control, or who are unwilling or unable to be tested for pregnancy. * Any condition that in the opinion of the investigator would make participation not in the best interest of the subject
Where this trial is running
Boston, Massachusetts and 1 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
- NYU Langone Health — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: David Charytan, MS, MSc — NYU Langone Health
- Study coordinator: David Charytan, MD, MSc
- Email: David.Charytan@nyulangone.org
- Phone: 617-935-1572
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: End Stage Renal Disease