CTIS2023-506295-26-00
Recruiting
Phase 1
Evolution of proteinuria in renal transplant patients treated with Dapagliflozin for nephroprotection. DAPAGREFFE - RECHMPL23_0102
niversity Hospital Of Montpellier0 sites70 target enrollmentStarted: July 13, 2023Last updated:
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- niversity Hospital Of Montpellier
- Enrollment
- 70
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •Initiation of dapagliflozin less than 14 days ago for chronic kidney disease, eGFR (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, For CKD Renal Transplant Recipients: kidney transplant more than one year
Exclusion Criteria
- •Guardianship or trusteeship, Patient undergoing treatment with another SGLT2 inhibitor (sodium\-glucose co\-transporter type 2\), Patient enrolled in another clinical trial, Pregnancy or breast\-feeding, 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 control group (non\-transplanted CKD) : history of transplantation, 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
Investigators
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