Evolution of Proteinuria in Renal Transplant Patients Treated with Dapagliflozin for Nephroprotection. DAPAGREFFE

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 chronic kidney disease (CKD) and the high risk of cardiovascular complications. Achieving blood pressure control and reducing proteinuria is therefore a major objective in the management of chronic renal failure. Until recently, inhibitors of the renin-angiotensin-aldosterone system were the only therapeutic class known to have both anti-proteinuric and anti-hypertensive action, reducing the risk of progression to end-stage renal disease. The Investigators intend to conduct an observational study with the primary objective of studying the evolution of proteinuria in kidney transplant patients treated with dapagliflozin according to the marketing authorization. The secondary objectives of the study are to investigate other expected benefits, including effects on renal function and metabolic effects, as well as potential side-effects of this treatment in this population.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
University Hospital of Montpellier
RECRUITING
Montpellier
Contact Information
Primary
Vincent PERNIN, MD
v-pernin@chu-montpellier.fr
033 467.33.84.80
Time Frame
Start Date: 2024-01-04
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 70
Treatments
Other: Dapagliflozine
For prospective cohort, an additional follow-up at D14 and M1 will be carried out.
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov