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RECRUITING
NCT05788276
PHASE4

Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?

Sponsor: Oslo University Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

330

Start Date

2023-05-02

Completion Date

2028-06

Last Updated

2025-04-01

Healthy Volunteers

No

Interventions

DRUG

Dapagliflozin 10mg Tab

Dapagliflozin active tablets

DRUG

Placebo

Matched placebo tablets

Locations (1)

Oslo University Hospital

Oslo, Oslo County, Norway