Dapagliflozin 10mg Tab: Randomization will take place at visit 1 to either the group receiving standard care and dapagliflozin or standard care only.
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
* Informed consent (§ 40 Abs. 1 Satz 3 Punkt 3 AMG) has to be given in written form
Exclusion Criteria:
* 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.
* eGFR \<25 ml/min/1.73m² (CKD-EPI Formula).
* Uncontrolled arterial hypertension (RR \> 180/110 mmHg).
* Congestive heart failure (CHF) NYHA stage IV.
* Recurrent urinary tract infections (bacterial or fungal)
* Severe disorders of the gastrointestinal tract or other diseases which interfere the pharmacodynamics and pharmacokinetics of the drug.
* Significant laboratory abnormalities such as SGOT or SGPT levels more than 5 x above the upper limit of normal range.
* Antihypertensives are allowed but should be kept stable throughout the study period.
* Statins and other antihyperlipidemic drugs are allowed but should be kept stable throughout the study period.
* Drug or alcohol abusus
* Pregnant or breast-feeding patients
* Patients with contraindications to MRI
Primary outcome measure(s)
renal morphology - fibroblasts — 3 months after randomization integrity of peritubular fibroblasts (PDGFRα) assessed from the routine one year follow up biopsy of the renal transplant
renal morphology - inflammation — 3 months after randomization 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 — 3 months after randomization markers of oxidative stress (Nox1, 8-OHdG) in the interstitium assessed from the routine one year follow up biopsy of the renal transplant
Trial sites (1)
Facility
City
Region
Status
Clinical Research Center (CRC)
Erlangen
Bavaria
Recruiting
More University of Erlangen-Nürnberg Medical School trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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