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Comparison of the effects of Belatacept and Anticalcineurins on endothelial function in kidney transplant patients - BELAFENDO

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515577-10-00
Acronym
2021/0391/HP
Enrollment
44
Registered
2024-10-01
Start date
2025-07-24
Completion date
Unknown
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney transplant

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

DRUGTACROLIMUS
DRUGNATISPRAY 0
DRUG30 mg/dose spray sublinguale
DRUGCICLOSPORIN

Sponsors

Centre Hospitalier Universitaire Rouen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026