Kidney DiseasesPhase 4BELAFENDONCT06291077
Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - <BELAFENDO>
A Phase 4 study testing Belatacept and anticalcineurins in people with Kidney Diseases, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- Belatacept and anticalcineurins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2026to 1 Feb 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 15Show fewer
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de ROUEN
Rouen, 76031
Rachna Baguant, Dr, 02 32 88 90 02, Rachna.Baguant@chu-rouen.fr
Rachna Baguant, Dr
About this study
Official title: Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients <BELAFENDO>
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
- Being tested
- Belatacept, anticalcineurins
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelataceptDrug
Changing of anticalcineurins by Belatacept
anticalcineurinsDrug
Keeping of anticalcineurins
| Study group | Role | What they receive |
|---|---|---|
| Belatacept group | Experimental | Belatacept group Receives: Drug: Belatacept |
| anticalcineurin group | Active comparator | anticalcineurin group Receives: Drug: anticalcineurins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start30 Apr 2026
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291077
- Sponsor's protocol ID
- 2021/0391/HP
- Acronym
- BELAFENDO
- Status last verified
- Jun 2026
- First submitted
- 26 Feb 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients <BELAFENDO>
- ClinicalTrials.gov ID
- NCT06291077
- Acronym / sponsor ID
- BELAFENDO / 2021/0391/HP
- Conditions
- Kidney Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belatacept group | Experimental | Drug: BelataceptBelatacept group |
| anticalcineurin group | Active comparator | Drug: anticalcineurinsanticalcineurin group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
- 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%)
- Date of kidney transplant greater than 1 year
- Age between 18 and 75 years inclusive
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelataceptChanging of anticalcineurins by Belatacept | Drug | Belatacept group |
| anticalcineurinsKeeping of anticalcineurins | Drug | anticalcineurin group |
Primary outcome
Replacement of anticalcineurins with Belatacept in kidney transplant patients allows an improvement in the endothelium-dependent dilation of peripheral conductance arteries
Time frame: at 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Kidney Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Belatacept and anticalcineurins in people with Kidney Diseases, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachna Baguant, Dr (02 32 88 90 02, Rachna.Baguant@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Replacement of anticalcineurins with Belatacept in kidney transplant patients allows an improvement in the endothelium-dependent dilation of peripheral conductance arteries (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.