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

Sponsor
University of Erlangen-Nürnberg Medical School
Study ID
NCT06560801
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Kidney Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg Tab — DRUG
    Randomization will take place at visit 1 to either the group receiving standard care and dapagliflozin or standard care only.

Study Details

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).

Key Dates

Start date
Jul 28, 2023
Status verified
Apr 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin
    Dapagliflozin + standard of care
  • No Intervention: Standard of care
    standard of care only

Primary Outcome Measure

renal morphology - fibroblasts [ Time Frame: 3 months after randomization ]

Related Studies