Belatacept vs calcineurin inhibitors and endothelial function in kidney transplant patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 trial compares Belatacept with anticalcineurins in kidney transplant recipients to see how each treatment affects endothelial function and vascular health. Eligible participants have had a transplant for at least one year and meet age and kidney function criteria. Researchers will assess vasomotor function and related cardiovascular markers to determine if Belatacept offers cardiovascular advantages while providing graft protection. The study is centered at CHU de Rouen in France and is led by the University Hospital, Rouen.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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)

    * using effective contraception according to the WHO (combined hormonal contraception (containing estrogens and progestins), progestin-only contraception, intrauterine device (IUD), male or female condoms) for at least 4 weeks before inclusion and during the study And,
    * presenting a negative urine pregnancy test at inclusion;
  * 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

Exclusion Criteria:

* 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
* Systolic heart failure requiring hospitalization in the 6 months preceding inclusion or known heart failure with an LVEF \<30%
* 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
* Patient participating or having participated in the 4 weeks preceding inclusion in a clinical trial

Where it's running

• CHU de ROUEN
  Rouen, France Recruiting

Study contacts

• Study coordinator: Rachna Baguant, Dr
• Email: Rachna.Baguant@chu-rouen.fr
• Phone: 02 32 88 90 02

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.