Effects of dapagliflozin on proteinuria in kidney transplant patients
Evolution of Proteinuria in Renal Transplant Patients Treated with Dapagliflozin for Nephroprotection. DAPAGREFFE
This study tests if the medication dapagliflozin can lower protein levels in the urine of kidney transplant patients and improve their kidney health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT06165601 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of dapagliflozin on proteinuria levels in kidney transplant patients who have recently started treatment. It aims to observe changes in proteinuria and assess additional benefits on renal function and metabolic health. The study includes follow-up assessments at two time points: 14 days and one month after treatment initiation. The research focuses on patients with chronic kidney disease and aims to provide insights into the nephroprotective effects of SGLT2 inhibitors.
Who should consider this trial
Good fit: Ideal candidates are kidney transplant patients who have initiated dapagliflozin treatment within the last 14 days and meet specific renal function criteria.
Not a fit: Patients who have undergone kidney transplantation less than one year ago or have severe liver failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of proteinuria and renal function in kidney transplant patients.
How similar studies have performed: Previous studies have shown that SGLT2 inhibitors can reduce cardiovascular complications and improve renal outcomes, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Initiation of dapagliflozin less than 14 days ago for chronic kidney disease * Glomerular Filtration Rate (GFR) (by CKD-EPI) between 25 and 75 ml.min.1.73m². * Albuminuria/Creatinuria ratio between 200 mg/g and 5000 mg/g * Treatment with an ACE inhibitor or angiotensin 2 receptor blocker (ARA II or sartan) at the maximum tolerated dose for at least 4 weeks. * Age ≥ 18 years Exclusion Criteria: * For study group (CKD Renal transplant recipients) : Renal transplantation \< 1 year old * For the control group (non-transplanted CKD) : history of transplantation of an other organ than a kidney initiation or modification of immunosuppressive therapy less than 6 months ago (except temporary discontinuation for infection or change in dosage) * Type 1 diabetes * Severe liver failure (Child-Pugh stage C) * Intolerance to any of the excipients of Forxiga®, in particular lactose intolerance * Patient undergoing treatment with another SGLT2 inhibitor (sodium-glucose co-transporter type 2) * Patient enrolled in another clinical trial * Pregnancy or breast-feeding * Guardianship or trusteeship * Patient protected by law * Subject not affiliated to a social security scheme, or not benefiting from such a scheme * Patient deprived of liberty * For the retrospective cohort: Patient's refusal to take part in the study after receiving the information note. * For the prospective cohort: Failure to obtain written informed consent after a period of reflection.
Where this trial is running
Montpellier
- University Hospital of Montpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Vincent PERNIN, MD
- Email: v-pernin@chu-montpellier.fr
- Phone: 033 467.33.84.80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.