TerminatedPhase 2

CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients

Stopped: The study closed per PI decision due to completion of the biopsy substudy and slow accrual

United States20 participantsStarted 2022-07-25

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 -

Exclusion criteria

✕. Type I diabetes
✕. Any other solid organ transplant
✕. Hemoglobin A1c greater than 12 %
✕. SGLT2i use at the time of enrollment
✕. Prior SGLT2i allergy or intolerance
✕. Pregnant or nursing at the time of enrollment
✕. 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

What they're measuring

Change in kidney function as measured by eGFR

Timeframe: Baseline, 6 months, 9 months, 12 months and 18 months

Change in kidney function as measured by albuminuria

Timeframe: Baseline, 6 months, 9 months, 12 months and 18 months

Change in cardiac structure

Timeframe: Baseline, month 9 and month15

Change in blood insulin level

Timeframe: Baseline, month 6 and month 18

Change in fasting blood sugar

Timeframe: Baseline, month 6 and month 18

Number of Urinary Tract infections

Timeframe: up to 18 months

Number of Genital infections

Timeframe: up to 18 months

Trial details

NCT IDNCT04906213

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-22

View on ClinicalTrials.gov More Kidney Transplant; Complications trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 -

Exclusion criteria

✕. Type I diabetes
✕. Any other solid organ transplant
✕. Hemoglobin A1c greater than 12 %
✕. SGLT2i use at the time of enrollment
✕. Prior SGLT2i allergy or intolerance
✕. Pregnant or nursing at the time of enrollment
✕. 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

What they're measuring

Change in kidney function as measured by eGFR

Timeframe: Baseline, 6 months, 9 months, 12 months and 18 months

Change in kidney function as measured by albuminuria

Timeframe: Baseline, 6 months, 9 months, 12 months and 18 months

Change in cardiac structure

Timeframe: Baseline, month 9 and month15

Change in blood insulin level

Timeframe: Baseline, month 6 and month 18

Change in fasting blood sugar

Timeframe: Baseline, month 6 and month 18

Number of Urinary Tract infections

Timeframe: up to 18 months

Number of Genital infections

Timeframe: up to 18 months