NCT06165601Completed
Proteinuria in Renal Transplant Patients Treated With Dapagliflozin
Evolution of Proteinuria in Renal Transplant Patients Treated With Dapagliflozin for Nephroprotection. DAPAGREFFE
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 55 (actual)
- First submitted
- 20 Nov 2023
- Start date
- 4 Jan 2024
- Primary completion date
- 25 Oct 2025
- Lead sponsor
- University Hospital, Montpellier
- Diseases
- Chronic kidney disease
- NCT number
- NCT06165601
- EU CT number
- 2023-506295-26-00
What you commit to
- Study type: Interventional
- Participants enrolled: 55
- From 4 Jan 2024 to the primary completion date, 25 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- For study group (CKD Renal transplant recipients) : Renal transplantation \< 1 year old
- For the retrospective cohort: Patient's refusal to take part in the study after receiving the information note.
Other illness
- 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)
- For the prospective cohort: Failure to obtain written informed consent after a period of reflection.
Lab values
- Patient undergoing treatment with another SGLT2 inhibitor (sodium-glucose co-transporter type 2)
Other
- Intolerance to any of the excipients of Forxiga®, in particular lactose intolerance
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.