RecruitingNot ApplicableNCT06165601

Proteinuria in Renal Transplant Patients Treated with Dapagliflozin

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


Sponsor

University Hospital, Montpellier

Enrollment

70 participants

Start Date

Jan 4, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria14

  • 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.

Interventions

PROCEDUREFollow-up at D14

A blood test and urinary test will be performed at D14.

PROCEDUREFollow-up at M1

A blood test and urinary test will be performed at M1.


Locations(1)

University Hospital of Montpellier

Montpellier, France

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NCT06165601


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