RecruitingPhase 4NCT06560801

Dapagliflozin on Renal Morphology and Renal Perfusion in Patients One Year After Kidney Transplantation

Randomized Clinical Study to Analyse the Effects of Dapagliflozin on Renal Morphology and Renal Perfusion in Patients With Impaired Renal Function One Year After Kidney Transplantation


Sponsor

University of Erlangen-Nürnberg Medical School

Enrollment

48 participants

Start Date

Jul 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study is to observe the mechanisms of dapagliflozin on the renal interstitial tissue and renal perfusion. For this purpose, renal transplanted patients as an excellent model of CKD and high cardiovascular risk (similar to patients in DAPA-CKD study) are included in this study. The objectives of the study are to analyze the effects of dapagliflozin on renal morphology and renal perfusion in patients with impaired renal function one year after kidney transplantation. This is a randomized (1:1), single centre clinical study. Each patient will be randomly assigned in an unblinded fashion to 10 mg Dapagliflozin or not 9 months after transplantation. At least 48 patients will be randomized and included. The routine renal biopsy taken one year after kidney transplantation will allow us to determine the morphological integrity of peritubular fibroblasts, interstitial inflammatory cell density and investigate markers of inflammation, oxidative stress and nitic oxide synthase expression (iNOS).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether dapagliflozin — a diabetes drug that also protects the kidneys — changes the structure or blood flow of transplanted kidneys when taken one year after a kidney transplant, regardless of whether the patient has diabetes. **You may be eligible if...** - You are aged 18–75 and received a kidney transplant at least 9 months ago - Your transplanted kidney is functioning at a stable level - You are not currently taking an SGLT-2 inhibitor (a class of diabetes medication) **You may NOT be eligible if...** - You have Type 1 diabetes - Your blood sugar control is very poor (HbA1c over 10%) - Your kidney function is significantly reduced - You have had a stroke, heart attack, or unstable chest pain in the past 3 months - You are pregnant or breastfeeding - You have contraindications to MRI scanning Talk to your doctor to see if this trial is right for you.

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

Randomization will take place at visit 1 to either the group receiving standard care and dapagliflozin or standard care only.


Locations(1)

Clinical Research Center (CRC)

Erlangen, Bavaria, Germany

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NCT06560801


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