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Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - <BELAFENDO>

Study acronym: BELAFENDO
StatusRecruiting
PhasePhase 4
Started2026-04-30
View on ClinicalTrials.gov ↗

Amendment history

2026-06-05
notable
Study Status, Contacts/Locations v2
Recruitment opened
Primary completion pushed: 2028-12-01 → 2029-02-01
Completion pushed: 2028-12-01 → 2029-02-01
Start dateestimated 2026-03-01→confirmed 2026-04-30
2026-02-05
minor
Study Status v1
Primary completion date2028-01-01→2028-12-01
Completion date2028-01-01→2028-12-01
Start date2025-01-01→2026-03-01
2024-02-26
minor
Original filing
Kidney transplantation is the standard treatment for patients with end-stage renal failure. However, anticalcineurin inhibitors, the most widely used immunosuppressants, are involved in the occurrence of cardiovascular events, a major cause of premature death in these patients. They play an important role in the occurrence of endothelial dysfunction and increased arterial stiffness by decreasing the synthesis of nitric oxide (NO), promoting intrarenal arterial vasoconstriction and stimulating the production of pro-inflammatory cytokines. leading to the development of hypertension and chronic graft dysfunction. Belatacept, a more recently developed immunosuppressant and co-stimulation signal inhibitor, has shown an anti-rejection effect similar to cyclosporine with a better cardiovascular tolerance profile. Preliminary studies are contradictory on the influence of Belatacept on arterial stiffness. Furthermore, to date, no study has evaluated the impact of Belatacept on vasomotor endothelial function in humans, an indicator of NO bioavailability. The interest of this study is to demonstrate that patients taking Belatacept have an improvement in vascular function compared to patients taking anticalcineurins in order to consider an earlier change in immunosuppressive strategy in the event of vascular damage.
Trial Details
NCT Number NCT06291077
Lead Sponsor University Hospital, Rouen
Conditions Kidney Diseases
Enrollment 44 participants
Start Date 2026-04-30
Primary Completion 2029-02-01 (estimated)
Study Completion 2029-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-09