2023-506295-26-00
Recruiting
Phase 4
Evolution of proteinuria in renal transplant patients treated with Dapagliflozin for nephroprotection. DAPAGREFFE
University Hospital Of Montpellier1 site in 1 country70 target enrollmentStarted: October 13, 2023Last updated:
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Decrease in albuminuria/creatinuria ratio ≥ 50% from baseline or achievement of albuminuria/creatinuria ratio ≤ 30 mg/g at 6 months after introduction of dapagliflozin
Overview
Brief Summary
Estimate the rate of patients, treated with Dapagliflozin, with a nephroprotective effect at 6 months after dapagliflozin initiation
Study Design
- Allocation
- Not Applicable
- Primary Purpose
- Treatment with dapagliflozin
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Decrease in albuminuria/creatinuria ratio ≥ 50% from baseline or achievement of albuminuria/creatinuria ratio ≤ 30 mg/g at 6 months after introduction of dapagliflozin
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 Outcomes
- Decrease in albuminuria/creatinuria ratio ≥ 50% from baseline or achievement of albuminuria/creatinuria ratio ≤ 30 mg/g, 3 months after introduction of dapagliflozin
- Decrease ≥ 50% in GFR from baseline to M3 et M6
- Number of patients with end-stage CKD as defined by dialysis or pre-emptive transplant replacement therapy at M6
- Numbers of episodes of acute renal failure defined according to KDIGO criteria (stage I: increase in serum creatinine ≥ 26.52 micromoles/L in 48 hours or increase in serum creatinine of ≥ 1.5 times the initial value in the preceding 7 days, stage II: increase in serum creatinine ≥ 2 times the initial value, stage III: increase in serum creatinine ≥ 3 times the initial value or serum creatinine ≥ 353. 6 mmol/l or need to start extrarenal purification at M3 and M6
- Death rate from any cause
- Study of interaction with immunosuppressive treatments (residual rate and change in dosage of immunosuppressive treatment) at M3 and M6
- Changes in blood pressure, weight and Hba1c from baseline to M3 et M6
- Occurrence of infectious side effects, including urinary tract infections, genital mycotic infections, Fournier's gangrene at M3 and M6
- Occurrence of metabolic side effects including diabetic ketoacidosis, hypoglycemia, dehydration, hypotension, hydrosodium depletion at M3 and M6
- Other adverse reactions associated with dapagliflozin at M3 and M6
- Discontinuation of treatment for side effects at M3 and M6
Investigators
Amelle ISSA
Scientific
University Hospital Of Montpellier
Study Sites (1)
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