CHU de ROUEN
Rouen, 76031, France
Location status: Recruiting
Location contact
Rachna Baguant, Dr
CONTACT
Rachna Baguant, Dr
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06291077
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 4
Rouen, 76031, France
Location status: Recruiting
Rachna Baguant, Dr
CONTACT
Rachna Baguant, Dr
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For the Belatacept group:
For the anticalcineurin group:
For both groups:
Exclusion criteria
Changing of anticalcineurins by Belatacept
Keeping of anticalcineurins
Time frame: at 6 months
The primary endpoint is to compare the variation over 6 months in the amplitude of endothelium-dependent dilation during the post-ischemic hyperemia maneuver (Paragraph 7.1) (visit V2 and V3) measured by vascular ultrasound with a automated software analysis in real time between the Bélatacept group and the anticalcineurin group.
Contact information is provided by the study sponsor or research team.
University Hospital, Rouen
Other
Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients <BELAFENDO>
Acronym: BELAFENDO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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