Proteinuria in Renal Transplant Patients Treated With Dapagliflozin

NCT06165601 | Completed

• 2 other identifiers: RECHMPL23_01022023-506295-26-00
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Change in albuminuria/creatinuria ratio at 6 months

  decrease in albuminuria/creatinuria ratio ≥ 50% from baseline or achievement of albuminuria/creatinuria ratio ≤ 30 mg/g

  From baseline to 6 months

Secondary Outcomes (13)

• Change in albuminuria/creatinuria ratio at 3 months

  From baseline to 3 months

• Change in glomerular filtration rate (GFR)

  From baseline to 3 and 6 months

• Number of patients with end-stage chronic kidney disease (CKD)

  From baseline to 3 and 6 months

• Number of episodes of acute renal failure

  From baseline to 3 and 6 months

• Death rate

  From baseline to 3 and 6 months

Study Arms (1)

Dapagliflozine

OTHER

For prospective cohort, an additional follow-up at D14 and M1 will be carried out.

Procedure: Follow-up at D14; Procedure: Follow-up at M1

Interventions

Follow-up at D14 PROCEDURE

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

Dapagliflozine

Follow-up at M1 PROCEDURE

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

Dapagliflozine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 11, 2023
• Study Start: January 4, 2024
• Primary Completion: October 25, 2025
• Study Completion: October 25, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

FR (1)