Belatacept for Kidney transplant

Inclusion criteria

• {"criterion_text":"- For the Belatacept group: - Patients who underwent a graft biopsy due to impaired renal function, finding criteria for chronic toxicity of anticalcineurins leading to the introduction of Belatacept.\n- For the anticalcineurin group: -Kidney transplant patients treated with anticalcineurin for more than one year.\n- For the anticalcineurin group: -Stable renal function (defined by a creatinine level in µmol/l stable for 3 months (variation +/-20%)\n- For both groups: Date of kidney transplant greater than 1 year\n- For both groups: Age between 18 and 75 years inclusive\n- For both groups: - Patient having received clear information from one of the investigators, having read and understood the information letter and signed the consent form\n- For both groups: - Women: o of childbearing age (defined by the CTCG as a fertile woman, after menarche and until menopause, except in cases of permanent sterility (including hysterectomy, bilateral salpingectomy or bilateral oophorectomy) • using effective contraception according to the CTCG (progestin-only oral hormonal contraception for which inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) for at least 4 weeks before inclusion, during the study and up to 8 weeks after the last dose of treatment And, - Having a negative urine pregnancy test at inclusion;\n- For both groups: - women: o Postmenopausal: Menopause according to CTCG is defined as the absence of menstruation for 12 months without other medical cause. A high level of follicle-stimulating hormone (FSH) in the postmenopausal interval can be used to confirm a postmenopausal state in women who are not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n- For both groups: - Patient benefiting from a social protection scheme"}

Exclusion criteria

• {"criterion_text":"- Chronic kidney disease stage 5 (defined by a CKD-EPI GFR <15 ml/min/1.73m²)\n- Previous or current treatment with Belatacept\n- Severe hypertension (BP ≥ 110 mm Hg and/or SBP ≥ 180 mm Hg)\n- Presence or history of functional or ligated bilateral arteriovenous fistula or bilateral thrombosis, preventing vascular explorations\n- Pregnant or breastfeeding woman, or lack of proven effective contraception\n- Excessive alcohol consumption (no more than 10 drinks per week)\n- Dialysis patient\n- History of myocardial infarction or stroke less than 6 months ago\n- Systolic heart failure requiring hospitalization within 6 months prior to inclusion or known heart failure with an LVEF <30%\n- BMI>35 kg/m²\n- Severe hepatic impairment (Child-Pugh class C)\n- Contraindication to NULOJIX 250 mg, powder for solution for infusion\n- Contraindication to NATISPRAY 0.30 mg/dose, oral spray solution (and in particular hypersensitivity to nitrate derivatives in accordance with the SPC (Summary of Product Characteristics) of NATISPRAY)\n- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, or guardianship or curatorship\n- Active smoking with a daily consumption of more than 21 mg of nicotine per day or taking nicotine substitutes with a dose greater than 21 mg/24 hours\n- Drug addiction or suspected illicit drug use\n- Patient participating or having participated in the 4 weeks preceding their inclusion in a clinical trial"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"6-month change in amplitude of endothelium-dependent dilation during post-ischemic hyperemia maneuver measured by vascular ultrasound with automated real-time software analysis (visits V2 and V3)."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"6-month variation measured during distal skin heating using echotracking (visits V2 and V3)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Carotid distensibility and Young's modulus measured 2 cm below bifurcation by echotracking; carotid-femoral pulse wave velocity (PWV) measured by applanation tonometry (visits V2 and V3), assessing 6-month variation."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Brachial and carotid arterial pressures and carotid augmentation index measured by applanation tonometry (visits V2 and V3); augmentation index defined as (systolic peak - inflection in protosystole) expressed as % of central pulse pressure."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"6-month variation in blood concentrations of nitrites and EETs measured (visits V2 and V3) as indicators of nitric oxide availability."}

France

Latest Decision Or Authorization Date

23-01-2026

Number Of Sites

1

Number Of Participants

44

Primary sponsor

Full Name

Centre Hospitalier Universitaire Rouen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France