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RECRUITING
NCT06560801
PHASE4

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

Sponsor: University of Erlangen-Nürnberg Medical School

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2023-07-28

Completion Date

2026-12-31

Last Updated

2024-08-19

Healthy Volunteers

No

Interventions

DRUG

Dapagliflozin 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