Effects of empagliflozin on kidney transplant recipients
CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients
This study is testing whether the diabetes medication empagliflozin can improve heart and kidney health in people who have had a kidney transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT04906213 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of empagliflozin, a medication used to treat type 2 diabetes, on kidney transplant recipients. It is a single-center, double-blinded, randomized trial involving 72 participants, equally divided between those with and without type 2 diabetes. Participants will be randomly assigned to receive either empagliflozin or a placebo, with follow-up visits every three months for 18 months to monitor vital signs, conduct lab tests, and perform echocardiograms and renal biopsies. The study aims to assess the cardiovascular and renal outcomes associated with SGLT2 inhibition in this population.
Who should consider this trial
Good fit: Ideal candidates are kidney transplant recipients who are at least 12 months post-transplant and have an eGFR of 30 ml/min or greater.
Not a fit: Patients with type 1 diabetes or those who have had other solid organ transplants will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve kidney and heart health in transplant recipients, particularly those with type 2 diabetes.
How similar studies have performed: Other studies have shown promising results with SGLT2 inhibitors in diabetic populations, suggesting potential benefits in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Equal to or greater than 12 months and up tp 60 months post kidney transplant 2. Estimated glomerular filtration rate (eGFR) equal to or greater than 30ml/min/1.73m squared at screening 3. Standard immunosuppression, including calcineurin inhibitor, Mycophenolate Mofetil or Sodium and a glucocorticoid 4. Able to provide written consent - Exclusion Criteria: 1. Type I diabetes 2. Any other solid organ transplant 3. Hemoglobin A1c greater than 12 % 4. SGLT2i use at the time of enrollment 5. Prior SGLT2i allergy or intolerance 6. Pregnant or nursing at the time of enrollment 7. History of antibody medicated rejection (AMR) or a Banff score greater than 2B for acute cellular rejection (ACR) 8. Active anticoagulant use other than aspirin 81 mg for primary prevention of cardiovascular disease 9. Known positive donor-specific antibodies prior to enrollment 10. Uncircumcised men 11. Greater than 2 urinary tract infections (UTI) over the 12 months prior to enrollment 12. Any genital infections over the 12 months prior to enrollment -
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Myles Wolf, MD — Duke University
- Study coordinator: Rachael Abuin, BSN
- Email: rachael.abuin@duke.edu
- Phone: 919-684 8136
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.