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Phase 4Active, not recruiting

Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys? (DEAKTransplant)

Sponsor
Oslo University Hospital (Academic or other)
Enrollment
330 planned
Conditions
Kidney Transplant; Complications; Kidney Transplant Failure; Renal Failure
Interventions
Dapagliflozin 10mg Tab; Placebo
Ages
adults, older adults
Registry
NCT05788276

Full record on ClinicalTrials.gov

From the registry

The goal of this clinical trial is to look at the effect of SGLT2 (Sodium glucose transporter 2) inhibition in patients receiving a kidney-transplant 6 weeks earlier at Oslo University hospital. Rikshospitalet. Investigators will search for answers along three pathways: Can SGLT2 inhibitor 1) preserve glomerular filtration rate (GFR), 2) reduce interstitial fibrosis in the kidney, and 3) favorably improve metabolic risk factors for graft failure such as visceral obesity, glucose intolerance and high blood pressure? The participants (N=330) will be randomized to either dapagliflozin 10 mg or placebo o.d. in a blinded fashion. Researchers will than use kidney transplant biopsies, measured GFR, blood pressure sampling, glucose tolerance test (OGTT), dual-energy X-ray absorptiometry (DXA scan) and estimated GFR from the two groups in comparison, to evaluate the effect treatment. The participants will be followed for a total of 3 years.

Primary outcomes

  • Effect of Dapagliflozin on the GFR slope in renal transplant patients (Main study)

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered