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

NCT06291077 | Recruiting Phase 4

• 1 other identifier: 2021/0391/HP
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Replacement of anticalcineurins with Belatacept in kidney transplant patients allows an improvement in the endothelium-dependent dilation of peripheral conductance arteries

  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.

  at 6 months

Study Arms (2)

Belatacept group

EXPERIMENTAL

Belatacept group

Drug: Belatacept

anticalcineurin group

ACTIVE COMPARATOR

anticalcineurin group

Drug: anticalcineurins

Interventions

Belatacept DRUG

Changing of anticalcineurins by Belatacept

Belatacept group

anticalcineurins DRUG

Keeping of anticalcineurins

anticalcineurin group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For the Belatacept group:
• \- Patients who have undergone a graft biopsy due to impaired renal function finding criteria for chronic toxicity of anticalcineurins leading to the introduction of Belatacept.
• For the anticalcineurin group:
• Renal transplant patients treated with anticalcineurins for more than a year.
• Stable renal function (defined by a creatinine level in µmol/l stable for 3 months (variation +/-20%)
• For both groups:
• Date of kidney transplant greater than 1 year
• Age between 18 and 75 years inclusive
• Patient having received clear information from one of the investigators, having read and understood the information letter and signed the consent form
• Women :
• of childbearing age (defined by the CTFG as a fertile woman, after menarche and until menopause, except in cases of permanent sterility (including hysterectomy, bilateral salpingectomy or bilateral oophorectomy)
• menopausal: menopause according to the CTFG is defined as the absence of periods for 12 months without any other medical cause. An elevated follicle-stimulating hormone (FSH) level 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.
• Patient benefiting from a social protection scheme

You may not qualify if:

• Stage 5 chronic renal failure (defined by a CKD-EPI GFR\<15 ml/min/1.73m²)
• Dialysis patient
• History of myocardial infarction or stroke less than 6 months old
• BMI\>35 kg/m²
• Severe hepatic insufficiency (Child-Pugh class C)
• Contraindication to NATISPRAY 0.30 mg/dose, solution for oral spray (and in particular hypersensitivity to nitrates in accordance with the SPC (Summary of Product Characteristics) of NATISPRAY)
• Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, or guardianship or curatorship
• Previous or current treatment with Belatacept
• Severe high blood pressure (DBP ≥ 110 mm Hg and/or SBP ≥ 180 mm Hg)
• Presence or history of functional or ligated or thrombosed bilateral arteriovenous fistula, preventing explorations
• Pregnant, breastfeeding woman, or absence of proven effective contraception
• Excessive alcohol consumption (no more than 10 drinks per week)
• 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
• Drug addiction or suspected illicit drug use

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

CHU de ROUEN

Rouen, 76031, France

RECRUITING

MeSH Terms

Conditions

Kidney Diseases

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Central Study Contacts

Rachna Baguant, Dr

CONTACT

02 32 88 90 02; Rachna.Baguant@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: April 30, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)