Belatacept for Heart graft dysfunction|Chronic kidney disease

Inclusion criteria

• {"criterion_text":"- Cardiac transplant patients for 3 months\n- Over 18 years of age\n- No DSA at D0 (positive threshold MFI> 2000)\n- Having a DFG < 30ml/min calculated according to the formula CKD EPI or a decrease in DFG of more than 50% between the day of the heart transplant and M3, stable for 15 days.\n- EBV positive serology\n- Having signed the consent after receiving informed information\n- 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\n- Having no difficulty in understanding and communicating with the investigator and his representatives\n- Beneficiaries of a Social Security scheme"}

Exclusion criteria

• {"criterion_text":"- 2nd heart transplant or other solid organ transplant\n- History of rejections\n- Cellular or humoral rejection at myocardial biopsy of M3 post TC Current viral infection of type CMV, EBV, HCV, HBV.....\n- HIV positive serology\n- Ongoing participation in another clinical study\n- 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\n- Pregnant or breastfeeding women\n- Person under guardianship, curatorship or safeguard of justice"}

Primary endpoints

• {"endpoint_text":"- Determination of plasma creatinine and calculation of clearance according to the formula CKD EPI at M3 and M12 post HT.","definition_or_measurement_approach":"Measurement of plasma creatinine and calculation of estimated glomerular filtration rate (eGFR) using the CKD-EPI formula at month 3 and month 12 post heart transplantation."}

Secondary endpoints

• {"endpoint_text":"- Myocardial biopsies between M3 and M12 post HT\n- Anti-HLA antibody testing according to the habits of heart transplant centres\n- Fasting blood glucose and HBA1C at M3 and M12 post HT\n- Death\n- Number of dialysis sessions between M3 and M12 post HT","definition_or_measurement_approach":"Myocardial biopsies performed between month 3 and month 12 post-transplant (details not specified). Anti-HLA antibody testing performed according to each centre's routine practices. Fasting blood glucose and HbA1c measured at M3 and M12. Death recorded as an event. Number of dialysis sessions counted between M3 and M12 post transplant."}

France

Earliest CTIS Part Ii Submission Date

02-08-2024

Latest Decision Or Authorization Date

07-01-2026

Processing Time Days

523

Number Of Sites

5

Number Of Participants

25

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nantes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France