Kidney transplant
Conditions
Brief summary
The primary endpoint is to compare the 6-month change in the amplitude of endothelium-dependent dilation during the post-ischemic hyperemia maneuver (Section 7.1) (visit V2 and V3) measured by vascular ultrasound with automated real-time software analysis between the Belatacept group and the ancalcineurin group.
Detailed description
To compare the 6-month variation in the amplitude of endothelium-dependent dilation during distal skin heating (Section 6.1) (visits V2 and V3) measured by echotraking (Section 6.1) between the Belatacept group and the anticalcineurin group., Compare the 6-month variation in distensibility and Young's elastic modulus, indicators of carotid stiffness, will be measured 2 cm below the bifurcation by echotracking (Section 6.1)(visits V2 and V3) between the Belatacept group and the anticalcineurin group. And the 6-month variation in carotid-femoral PWV, an indicator of aortic stiffness, will be measured by applanation tonometry (Section 6.1)(visits V2 and V3) between the Belatacept group and the anticalcineurin group., To compare the 6-month change in brachial and carotid arterial pressure measurements and in the carotid augmentation index, an indicator of cardio-circulatory coupling, measured by applanation tonometry (Section 6.1) (visits V2 and V3) between the Belatacept group and the anticalcineurin group. The augmentation index is calculated as the difference between the systolic peak and the inflection in protosystole, expressed as a percentage of the central pulse pressure., To compare the 6-month variation in blood concentrations of nitrites and epoxyeicosatrienoic acids (EETs) (Section 6.1), an indicator of NO availability between 44°C and 34°C (visits V2 and V3) between the Belatacept group and the anticalcineurin group.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is to compare the 6-month change in the amplitude of endothelium-dependent dilation during the post-ischemic hyperemia maneuver (Section 7.1) (visit V2 and V3) measured by vascular ultrasound with automated real-time software analysis between the Belatacept group and the ancalcineurin group. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the 6-month variation in the amplitude of endothelium-dependent dilation during distal skin heating (Section 6.1) (visits V2 and V3) measured by echotraking (Section 6.1) between the Belatacept group and the anticalcineurin group., Compare the 6-month variation in distensibility and Young's elastic modulus, indicators of carotid stiffness, will be measured 2 cm below the bifurcation by echotracking (Section 6.1)(visits V2 and V3) between the Belatacept group and the anticalcineurin group. And the 6-month variation in carotid-femoral PWV, an indicator of aortic stiffness, will be measured by applanation tonometry (Section 6.1)(visits V2 and V3) between the Belatacept group and the anticalcineurin group., To compare the 6-month change in brachial and carotid arterial pressure measurements and in the carotid augmentation index, an indicator of cardio-circulatory coupling, measured by applanation tonometry (Section 6.1) (visits V2 and V3) between the Belatacept group and the ant | — |
Countries
France