RecruitingPhase 4NCT05788276

Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?


Sponsor

Oslo University Hospital

Enrollment

330 participants

Start Date

May 2, 2023

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dapagliflozin 10mg Tab and a drug called Placebo for people with kidney transplant failure, kidney transplant; complications, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDapagliflozin 10mg Tab

Dapagliflozin active tablets

DRUGPlacebo

Matched placebo tablets


Locations(1)

Oslo University Hospital

Oslo, Oslo, Norway

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NCT05788276


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