BridgeMD
New treatment option for Kidney Diseases
Official title Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - <BELAFENDO>
ClinicalTrials.gov ID: NCT06291077
What this study is testing
What is Belatacept?
Belatacept is an investigational medicine, being studied as a potential treatment for kidney diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- For the Belatacept group: \- Patients who have undergone a graft biopsy due to impaired renal function finding criteria for chronic toxicity of...
- 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
You likely can't join 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
- 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)
See the full eligibility 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...
- 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...
- 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...
- Patient benefiting from a social protection scheme
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rouen, France
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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rouen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.