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Comparison of the effects of Belatacept and Anticalcineurins on endothelial function in kidney transplant patients - BELAFENDO
EU CTIS ID: 2024-515577-10-00
What this study is testing
To demonstrate that replacing anticalcineurins with Belatacept in kidney transplant patients results in a 6-month improvement in endothelium-dependent dilation of peripheral conductance arteries in response to postischemic hyperemia compared to kidney transplant patients maintaining anticalcineurin therapy.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- For the anticalcineurin group: -Kidney transplant patients treated with anticalcineurin for more than one year.
- For the anticalcineurin group: -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
- For both groups: Age between 18 and 75 years inclusive
- 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
You likely can't join if
- Chronic kidney disease stage 5 (defined by a CKD-EPI GFR <15 ml/min/1.73m²)
- BMI>35 kg/m²
- Severe hepatic impairment (Child-Pugh class C)
- Contraindication to NULOJIX 250 mg, powder for solution for infusion
- 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)
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, or guardianship or curatorship
See the full eligibility criteria
- 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.
- For the anticalcineurin group: -Kidney transplant patients treated with anticalcineurin for more than one year.
- For the anticalcineurin group: -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
- For both groups: Age between 18 and 75 years inclusive
- 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
- 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;
- 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.
- For both groups: - Patient benefiting from a social protection scheme
- Chronic kidney disease stage 5 (defined by a CKD-EPI GFR <15 ml/min/1.73m²)
- BMI>35 kg/m²
- Severe hepatic impairment (Child-Pugh class C)
- Contraindication to NULOJIX 250 mg, powder for solution for infusion
- 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)
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, or guardianship or curatorship
- 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 their inclusion in a clinical trial
- Previous or current treatment with Belatacept
- Severe hypertension (BP ≥ 110 mm Hg and/or SBP ≥ 180 mm Hg)
- Presence or history of functional or ligated bilateral arteriovenous fistula or bilateral thrombosis, preventing vascular explorations
- Pregnant or breastfeeding woman, or lack of proven effective contraception
- Excessive alcohol consumption (no more than 10 drinks per week)
- Dialysis patient
- History of myocardial infarction or stroke less than 6 months ago
- Systolic heart failure requiring hospitalization within 6 months prior to inclusion or known heart failure with an LVEF <30%
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.