Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?

Condition(s) studied

Investigational drug(s) / intervention(s)

Dapagliflozin 10mg Tab: Dapagliflozin active tablets

Placebo: Matched placebo tablets

Study 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.

Eligibility

Primary outcome measure(s)

• Effect of Dapagliflozin on the GFR slope in renal transplant patients (Main study) — From before randomization to 3 years after transplantation.
  1\. Difference in eGFR slope between groups.

Trial sites (1)

More Oslo University Hospital trials in Norway

Other trials for the same condition