Randomized clinical study to analyse the effects of dapagliflozin on renal morphology and renal perfusion in patients with impaired renal function one year after kidney transplantation
Key facts
- Where
- Erlangen, NémetországSee the site
- Phase
- 4. fázis
Where in Németország
- Universitaetsklinikum Erlangen AöRErlangen, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitaetsklinikum Erlangen AöR
- Trial code
- EU 2024-517885-40-00
- Record updated
- 2024. szeptember 18.
- Original description
The primary objective is to analyze the effect of dapagliflozin on renal morphology (e.g. integrity of peritubular fibroblasts (PDGFRα)), markers of inflammation (CD3, CD68, CD163) and oxidative stress (Nox1, 8-OHdG) in the interstitium assessed from the routine one year follow up biopsy of the renal transplantRead full original descriptionShow less
Randomized clinical study to analyse the effects of dapagliflozin on renal morphology and renal perfusion in patients with impaired renal function one year after kidney transplantation
The primary objective is to analyze the effect of dapagliflozin on renal morphology (e.g. integrity of peritubular fibroblasts (PDGFRα)), markers of inflammation (CD3, CD68, CD163) and oxidative stress (Nox1, 8-OHdG) in the interstitium assessed from the routine one year follow up biopsy of the renal transplant
Inclusion: 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 has to be given in written form.
Exclusion: Statins and other antihyperlipidemic drugs are allowed but should be kept stable throughout the study period; Drug or alcohol abusus; 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; Type 1 diabetes mellitus; 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; HbA1c > 10%; eGFR <25 ml/min/1.73m² (CKD-EPI Formula); Antihypertensives are allowed but should be kept stable throughout the study period; Pregnant or breast-feeding patients; Patients with contraindications to MRI.