Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?
Status:
Not yet recruiting
Trial end date:
2028-06-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Oslo University Hospital
Collaborators:
Haukeland University Hospital St. Olavs Hospital University Hospital of North Norway