Dapagliflozin on Renal Morphology and Renal Perfusion in Patients One Year After Kidney Transplan… (NCT06560801) | Clinical Trial Compass
RecruitingPhase 4
Dapagliflozin on Renal Morphology and Renal Perfusion in Patients One Year After Kidney Transplantation
Germany48 participantsStarted 2023-07-28
Plain-language 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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
renal morphology - fibroblasts
Timeframe: 3 months after randomization
2
renal morphology - inflammation
Timeframe: 3 months after randomization
3
renal morphology - oxidative stress
Timeframe: 3 months after randomization
Trial details
NCT IDNCT06560801
SponsorUniversity of Erlangen-Nürnberg Medical School