Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Kidney Transplant; Complications, Kidney Transplant Failure, Renal Failure

In brief

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.

Key facts

Study ID

NCT05788276

Run by

Oslo University Hospital

People needed

330

Starts

2023-05-02

Expected to finish

2028-06-01

Last updated by the study team

2025-04-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Oslo University Hospital — Oslo, Oslo, Norway (enrolling)

Full record on ClinicalTrials.gov

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