Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?

Sponsor
Oslo University Hospital
Study ID
NCT05788276
Phase
PHASE4
Status
Recruiting
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Conditions

  • Kidney Transplant Failure
  • Kidney Transplant; Complications
  • Renal Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 2, 2023
Status verified
Mar 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
330 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Active treatment
    165 patients
  • Placebo Comparator: Control group
    165 patients

Primary Outcome Measure

Effect of Dapagliflozin on the GFR slope in renal transplant patients (Main study) [ Time Frame: From before randomization to 3 years after transplantation. ]

Central Contacts

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