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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
EU CTIS ID: 2024-517885-40-00
What this study is testing
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
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Type 1 diabetes mellitus
- 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
See the full eligibility 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 has to be given in written form
- Type 1 diabetes mellitus
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.