Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOslo University Hospital

About this trial

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 criteria

Qualifiers

Renal transplant recipients transplanted 6 weeks earlier at Oslo University hospital (OUH) Rikshospitalet.

Age 18-75 years.

Able to comply with the medical treatment on their own.

Calcineurin inhibitor trough concentrations in accordance with individual therapeutic range and standard dose prednisolone and mycophenolate mofetil over the last 2 weeks.

Disqualifiers

Type 1 diabetes

Rejection episodes of the kidney graft prior to randomization.

Ongoing infectious disease or intermittent causes affecting renal function, e.g., obstructive lymphocele.

Malnutrition.

Trial design

Treatments tested in this trial

  • Dapagliflozin 10mg Tab
  • Placebo

Treatment groups

330 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Oslo University Hospital

Lead sponsor

St. Olavs Hospital

Collaborator

University Hospital of North Norway

Collaborator

Haukeland University Hospital

Collaborator