Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?

• Status: Not yet recruiting
• Trial end date: 2028-06-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Collaborators: Haukeland University Hospital; St. Olavs Hospital; University Hospital of North Norway
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

• 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.

• Estimated GFR ≥25 mL/min/1.73 m2.

Exclusion Criteria:

• Repeat transplantation

• 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.

• Urosepsis less than 1 year prior to randomization.

• Participants with a known hypersensitivity to dapagliflozin or any of the excipients of the product.

• For women only - currently pregnant