Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?
Oslo University Hospital
330 participants
May 2, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria7
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Dapagliflozin active tablets
Matched placebo tablets
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05788276