Evolution of proteinuria in renal transplant patients treated with Dapagliflozi

Phase 1

Recruiting

Conditions: chronic renal failure
MedDRA version: 21.1Level: PTClassification code: 10064848Term: Chronic kidney disease Class: 100000004857
Therapeutic area: Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]

Registration Number: CTIS2023-506295-26-00

Lead Sponsor: niversity Hospital Of Montpellier

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 70

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Estimate the rate of patients, treated with Dapagliflozin, with a nephroprotective effect at 6 months after dapagliflozin initiation;Secondary Objective: Evaluate the effect of dapagliflozin on metabolic complications : diabetes, hypertension, dyslipidemia, Evaluate the side effects related to dapagliflozin, Compare the evolution of proteinuria in proteinuric CKD kidney transplant patients with a control group of non-transplant proteinuric CKD patients treated with Dapagliflozin in the same indication;Primary end point(s): Decrease in albuminuria/creatinuria ratio = 50% from baseline or achievement of albuminuria/creatinuria ratio = 30 mg/g at 6 months after introduction of dapagliflozin

Secondary Outcome Measures