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

Primary Purpose

Heart Transplant Failure

Status

Recruiting

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Belatacept Injection

About this trial

This is an interventional treatment trial for Heart Transplant Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Karine NubretRecruiting
Laurent SebbagRecruiting
Claire GarandeauRecruiting
Bertrand LelongRecruiting
Emmanuelle VermesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BELATACEPT

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Myocardial biopsies

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

Anti-human leukocyte antigen antibody assay

To check the risk of rejection

Fasting blood glucose and glycated haemoglobin (HBA1C)

Measurement of the New Onset Diabetes After Transplantation

Death

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

Number of dialysis sessions

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

Full Information

NCT ID

NCT04180085

First Posted

November 25, 2019

Last Updated

March 24, 2022

Sponsor

Nantes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04180085

Brief Title

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

Acronym

BELACOEUR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 6, 2020 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Transplant Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BELATACEPT

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Belatacept Injection

Intervention Description

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

Primary Outcome Measure Information:

Title

Clearance

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Myocardial biopsies

Description

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

Time Frame

12 months

Title

Anti-human leukocyte antigen antibody assay

Description

To check the risk of rejection

Time Frame

12 months

Title

Fasting blood glucose and glycated haemoglobin (HBA1C)

Description

Measurement of the New Onset Diabetes After Transplantation

Time Frame

12 months

Title

Death

Description

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

Time Frame

12 months

Title

Number of dialysis sessions

Description

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

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Claire GARANDEAU, PH

Phone

0240087453

claire.garandeau@chu-nantes.fr

Facility Information:

Facility Name

Karine Nubret

City

Bordeaux

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karine Nubret

Phone

0556795679

Karine.nubret@chu-bordeaux.fr

Facility Name

Laurent Sebbag

City

Lyon

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurent Sebbag

Phone

06.99.38.58.23

laurent.sebbag@chu-lyon.fr

Facility Name

Claire Garandeau

City

Nantes

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Claire Garandeay

Phone

0240087453

claire.garandeau@chu-nantes.fr

Facility Name

Bertrand Lelong

City

Rennes

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bertrand Lelong

Phone

0299284118

bernard.lelong@chu-rennes.fr

Facility Name

Emmanuelle Vermes

City

Tours

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emmanuelle Vermes

Phone

0247475918

e.vermes@chu-tours.fr

12. IPD Sharing Statement

Learn more about this trial

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

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