NCT06291077

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Kidney Diseases

Interventions

Type	Name	Description
DRUG	Belatacept	Changing of anticalcineurins by Belatacept
DRUG	anticalcineurins	Keeping of anticalcineurins

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2024-03-04
• Last updated: 2026-02-06