Dapagliflozin on Renal Morphology and Renal Perfusion in Patients One Year After Kidney Transplantation
Recruiting · NCT06560801 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Erlangen-Nürnberg Medical School
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
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
Where it is running
1 location listed.
- Clinical Research Center (CRC) - Erlangen, Bavaria, Germany