Effects of Dapagliflozin on Kidney Health After Transplant
Official title: 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
Run by University of Erlangen-Nürnberg Medical School · NCT06560801 · Data updated 2026-11-12
This study is testing if the medication dapagliflozin can help improve kidney health in people who have recently had a kidney transplant.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Locations | 1 site (Erlangen, Bavaria) |
| Status | Recruiting |
| Started | July 28, 2023 |
| Main results expected | October 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT06560801 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 who have received a kidney transplant and have stable kidney function nine months post-surgery.
✕Probably not a fit
Patients with type 1 diabetes, uncontrolled hypertension, or severe heart failure may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to investigate how dapagliflozin affects kidney morphology and blood flow in patients who have undergone kidney transplantation. It involves a randomized, single-center design where participants will be assigned to receive either dapagliflozin or no treatment nine months post-transplant. The study will analyze renal biopsies taken one year after transplantation to assess the health of kidney tissue and the presence of inflammation. The findings could provide insights into the benefits of dapagliflozin for improving kidney function in this patient population.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney health and reduced cardiovascular risks for patients after kidney transplantation.
How similar studies have gone: Previous studies with SGLT2 inhibitors have shown promising results in improving kidney outcomes, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Clinical Research Center (CRC)
Erlangen, Bavaria, Germany Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.