Can a newer drug protect heart health after kidney transplant?
NCT ID NCT06291077
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at kidney transplant patients who take immunosuppressants to prevent organ rejection. It compares the effects of belatacept, a newer drug, against standard anticalcineurins on blood vessel function. The goal is to see if belatacept improves vascular health and reduces heart risks. About 44 participants will be followed for 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Belatacept
- What this could lead to
- If successful, this could show that switching to belatacept improves blood vessel function, potentially reducing heart risks in kidney transplant patients.
- What could go wrong
- This is a small, early-phase study with only 44 participants, so results may not apply broadly. Belatacept may not improve vessel function as hoped, and patients still need lifelong immunosuppression.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de ROUEN
RECRUITINGRouen, 76031, France
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