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

NCT06560801 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-05-06

No results posted yet for this study

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).

Conditions

  • Chronic Kidney Diseases

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.

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-28
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06560801 on ClinicalTrials.gov