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Heart Transplant FailurePhase 2BELACOEURNCT04180085

Pilot Study: Interest of Belatacept as a Non-nephrotoxic Immunosuppressive Treatment in Cardiac Transplant Patients at Risk of Chronic Renal Failure (BELACOEUR)

A Phase 2 study testing Belatacept Injection in people with Heart Transplant Failure, run by Nantes University Hospital at 4 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Heart transplantation (TC) is the standard treatment for terminal heart failure. Chronic kidney disease (CKD) is a common complication responsible for increased mortality and morbidity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Transplant Failure
What is being tested?
Belatacept Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
4 sitesFrance
Study dates
6 Feb 2020to 1 Jan 2028
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cardiac transplant patients for 3 months Over 18 years of age No Donor Specific Antibodies at inclusion (positive threshold average fluorescence intensity (MFI)> 2000) Having a GFR (DFG in french) is the single best indicator of overall renal function < 30ml/min calculated according to the formula CKD EPI or a decrease in GFR of more than 50% between the day of the heart transplant and 3 months, stable for 15 days.
  • Induction treatment with anti-lymphocyte serum Virus d'Epstein-Barr positive serology Having signed the consent after receiving informed information Negative pregnancy test for patients of childbearing age, and agreement to use effective contraception throughout the study and 6 weeks after the end of the study Having no difficulty in understanding and communicating with the investigator and his representatives Beneficiaries of a Social Security scheme

Who cannot join

  • The criteria for non-inclusion are:
  • 2nd heart transplant or other solid organ transplant History of rejections Cellular or humoral rejection at myocardial biopsy of 3 months post Transplantation Cardiac Current viral infection of type cytomegalovirus, Virus d'Epstein-Barr, hepatitis C virus, hepatitis V virus.....
  • Human immunodeficiency virus positive serology Ongoing participation in another clinical study Any clinical condition that the investigator considers incompatible with the conduct of the study under acceptable safety conditions: (in particular, progressive infection, progressive cardiovascular complication, progressive neoplastic disease) Inability of the patient to comply with study procedures Pregnant or breastfeeding women Person under guardianship, curators or safeguard of justice

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Claire GARANDEAU, PH contact

0240087453

claire.garandeau@chu-nantes.fr

France4 sites, 4 recruiting

  • Karine Nubret

    Bordeaux

    Karine Nubret, 0556795679, Karine.nubret@chu-bordeaux.fr

    Recruiting

  • Laurent Sebbag

    Lyon

    Laurent Sebbag, 06.99.38.58.23, laurent.sebbag@chu-lyon.fr

    Recruiting

  • Claire Garandeau

    Nantes

    Claire Garandeay, 0240087453, claire.garandeau@chu-nantes.fr

    Recruiting

  • Bertrand Lelong

    Rennes

    Bertrand Lelong, 0299284118, bernard.lelong@chu-rennes.fr

    Recruiting

Other trials in France

About this study

Official title: Pilot Study: Interest of Belatacept as a Non-nephrotoxic Immunosuppressive Treatment in Cardiac Transplant Patients at Risk of Chronic Renal Failure

Heart transplantation (TC) is the standard treatment for terminal heart failure. Chronic kidney disease (CKD) is a common complication responsible for increased mortality and morbidity. The main risk factors for progression to CKD are advanced age, pre-transplantation CKD, degradation of glomerular filtration rate (GFR) in the first year post-transplantation, and nephrotoxicity of calcineurin inhibitors (CNI).

Indeed, these molecules (cyclosporin and tacrolimus), the cornerstone of immunosuppressive treatment, have nephrotoxic effects in the short term (by a hemodynamic effect) and in the long term (by a pro-fibrosin effect).

In renal transplantation (TR), belatacept, a costimulation-inhibiting molecule, used de novo, without CNI, with induction by anti-receptor antibody of Interleukines 2, preserves kidney function. Despite this great advantage, its development is still hampered by a higher number of rejections compared to the CNI group in this originator study. Based on the experience gained in TR, which has since validated its use, the hypothesis is that in heart transplantation, belatacept (Nulojix) combined with minimization of CNI (with induction by antilymphocyte serum), could significantly improve glomerular filtration rate (GFR) in patients at risk of CKD (by removing them from dialysis and possible kidney transplantation) without increasing the risk of rejection.

Being tested
Belatacept Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Belatacept InjectionDrug

    9 injections of belatacept at 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months 11 months and 12 months post graft

Study groups in NCT04180085
Study groupRoleWhat they receive
BELATACEPTExperimentalNot described
Receives: Drug: Belatacept Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clearance

    Determination of plasma creatinine and calculation of clearance according to the formula CKD EPI (Chronic Kidney Disease - Epidemiology Collaboration) at 3 months and 12 months post heart transplantation

    Measured: 12 months

Secondary outcomes (5)

  1. Myocardial biopsies

    Myocardial biopsies between 3 months and 12 months post Cardiac Transplantation to check the risk of rejection

    Measured: 12 months

  2. Anti-human leukocyte antigen antibody assay

    To check the risk of rejection

    Measured: 12 months

  3. Fasting blood glucose and glycated haemoglobin (HBA1C)

    Measurement of the New Onset Diabetes After Transplantation

    Measured: 12 months

  4. Death

    Evaluate the mortality specific to 12 months post cardiac transplantation (Estimate: percentage of patients who died at 12 months).

    Measured: 12 months

  5. Number of dialysis sessions

    Evaluate the use of renal replacement therapy between 3 months and 12 months after Cardiac Transplantation.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2019
  2. Study start6 Feb 2020
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04180085
Sponsor's protocol ID
RC19_0133
Acronym
BELACOEUR
Status last verified
Jan 2026
First submitted
25 Nov 2019
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Belatacept Injection in people with Heart Transplant Failure, run by Nantes University Hospital at 4 sites 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 2 inclusion and 3 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 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Claire GARANDEAU, PH (0240087453, claire.garandeau@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clearance (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04180085.

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 15 Jan 2026.

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