Interest of belatacept as a non-nephrotoxic immunosuppressive treatment in cardiac transplant patients at risk of chronic renal failure.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001510-42-FR

Enrollment

Registered

2019-07-30

Start date

2019-11-25

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early graft dysfunction after heart transplant MedDRA version: 21.1 Level: LLT Classification code 10064694 Term: Heart graft dysfunction System Organ Class: 100000004863

Interventions

Trade Name: Nulojix 250mg, poudre pour solution à diluer pour perfusion Product Name: BELATACEPT Pharmaceutical Form: Powder for solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The inclusion criteria are: Cardiac transplant patients for 3 months Over 18 years of age No DSA at D0 (positive threshold MFI> 2000) Having a DFG =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

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 M3 post TC Current viral infection of type CMV, EBV, HCV, HBV..... HIV 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 Inability of the patient to comply with study procedures Pregnant or breastfeeding women Person under guardianship, curatorship or safeguard of justice Translated with www.DeepL.com/Translator

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to observe a significant improvement in DFG (clearance calculated according to the CKD EPI formula) of 20 ml/min between M3 and M12 post TC, in cardiac transplant patients at risk of CKD, treated with 9 monthly infusions of belatacept associated with a progressive decrease in calcineurin inhibitors.;Secondary Objective: The secondary objectives are: Demonstrate that if there is a risk of rejection (> grade 2) it is less than 30% during the first year of the heart transplant as found in the literature (non-inferiority criterion) Quantify the percentage of patients developing NODAT (New Onset Diabetes After Transplantation) at M3 and M12 post-TC (Estimate). Evaluate the mortality specific to M12 post TC (Estimate). Evaluate the use of renal replacement therapy between M3 and M12 post-TC.;Primary end point(s): Determination of plasma creatinine and calculation of clearance according to the formula CKD EPI at M3 and M12 post HT.;Timepoint(s) of evaluation of this end point: 9 months	—

Measure

Time frame

Main Objective: The main objective is to observe a significant improvement in DFG (clearance calculated according to the CKD EPI formula) of 20 ml/min between M3 and M12 post TC, in cardiac transplant patients at risk of CKD, treated with 9 monthly infusions of belatacept associated with a progressive decrease in calcineurin inhibitors.;Secondary Objective: The secondary objectives are: Demonstrate that if there is a risk of rejection (> grade 2) it is less than 30% during the first year of the heart transplant as found in the literature (non-inferiority criterion) Quantify the percentage of patients developing NODAT (New Onset Diabetes After Transplantation) at M3 and M12 post-TC (Estimate). Evaluate the mortality specific to M12 post TC (Estimate). Evaluate the use of renal replacement therapy between M3 and M12 post-TC.;Primary end point(s): Determination of plasma creatinine and calculation of clearance according to the formula CKD EPI at M3 and M12 post HT.;Timepoint(s) of evaluation of this end point: 9 months

—

Secondary

Measure	Time frame
Secondary end point(s): - Myocardial biopsies between M3 and M12 post HT - Anti-HLA antibody testing according to the habits of heart transplant centres - Fasting blood glucose and HBA1C at M3 and M12 post HT - Death - Number of dialysis sessions between M3 and M12 post HT;Timepoint(s) of evaluation of this end point: 9 months	—

Countries

France

Contacts

Public ContactDirection Recherche, CHU de Nantes

CHU de Nantes

bp-prom-regl@chu-nantes.fr+33(0)253482853

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026