NCT04906213TerminatedPhase 2
CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Reason given: The study closed per PI decision due to completion of the biopsy substudy and slow accrual
Brief summary (registry, in English)
CREST-KT is a single-center, double-blinded, randomized trial of empagliflozin therapy in 72 kidney transplant recipients with (n=36) and without type 2 diabetes (n=36). After evenly dividing patients by type 2 diabetes diagnosis, patients will be randomized 2:1 to empagliflozin 10mg versus placebo.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 18 May 2021
- Start date
- 25 Jul 2022
- Primary completion date
- 22 Jan 2026
- Lead sponsor
- Duke University
- Diseases
- Type 2 diabetes
- NCT number
- NCT04906213
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any other solid organ transplant
- Prior SGLT2i allergy or intolerance
- Known positive donor-specific antibodies prior to enrollment
- Greater than 2 urinary tract infections (UTI) over the 12 months prior to enrollment
- Any genital infections over the 12 months prior to enrollment -
Other illness
- Type I diabetes
- History of antibody medicated rejection (AMR) or a Banff score greater than 2B for acute cellular rejection (ACR)
- Active anticoagulant use other than aspirin 81 mg for primary prevention of cardiovascular disease
Lab values
- Hemoglobin A1c greater than 12 %
Other
- SGLT2i use at the time of enrollment
- Pregnant or nursing at the time of enrollment
- Uncircumcised men
Who the study is looking for
- Equal to or greater than 12 months and up tp 60 months post kidney transplant
- Estimated glomerular filtration rate (eGFR) equal to or greater than 30ml/min/1.73m squared at screening
- Standard immunosuppression, including calcineurin inhibitor, Mycophenolate Mofetil or Sodium and a glucocorticoid
- Able to provide written consent -
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Medical Center | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.