Skip to main content
Clinical Trials/2023-506295-26-00
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

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Amelle ISSA

Scientific

University Hospital Of Montpellier

Study Sites (1)

Loading locations...

Similar Trials