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).
Female and male patients aged between 18 and 75 years
Patients with renal transplant having a stable eGFR, who are in stable condition, 9 months after transplantation, irrespective of their diabetes status
Females of child bearing potential must be using adequate contraceptive precautions
Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit
Type 1 diabetes mellitus.
HbA1c > 10%
Use of SGLT-2 inhibitor within the past 2 months
Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 3 months prior to study inclusion.
Parallel
Dapagliflozin 10mg Tab
DrugRandomization will take place at visit 1 to either the group receiving standard care and dapagliflozin or standard care only.
renal morphology - fibroblasts
integrity of peritubular fibroblasts (PDGFRα) assessed from the routine one year follow up biopsy of the renal transplant
renal morphology - inflammation
markers of inflammation (example CD3, CD68, CD163) in the interstitium from the routine one year follow up biopsy of the renal transplant
renal morphology - oxidative stress
markers of oxidative stress (Nox1, 8-OHdG) in the interstitium assessed from the routine one year follow up biopsy of the renal transplant
mRNA Expression profile of transcripts
mRNA Expression profile of transcripts relevant in renal transplantation using the Human Organ Transplant Panel of NanoString including 770 genes.
renal perfusion
renal perfusion of the renal transplant measured by ASL-MRI
central (aortic) systolic pressurepulse pressure
central (aortic) systolic pressure and pulse pressure
pulse pressure
pulse pressure
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