Status:
RECRUITING
Proteinuria in Renal Transplant Patients Treated with Dapagliflozin
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The prevalence of chronic kidney disease is rising steadily and represents a major public health challenge. Hypertension and proteinuria are two factors strongly associated with the progression of chr...
Detailed Description
Recent years have seen the emergence of sodium-glucose co-transporter type 2 (SGLT2) inhibitors, also known as gliflozins, which represent a real therapeutic innovation in the management of type 2 dia...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06165601
Start Date
January 4 2024
End Date
January 1 2026
Last Update
March 6 2025
Active Locations (1)
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1
University Hospital of Montpellier
Montpellier, France, 34295