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Interest of belatacept as a non-nephrotoxic immunosuppressive treatment in cardiac transplant patients at risk of chronic renal failure.
EU CTIS ID: 2024-516541-40-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Cardiac transplant patients for 3 months
- Over 18 years of age
- No DSA at D0 (positive threshold MFI> 2000)
- 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.
- EBV positive serology
- Having signed the consent after receiving informed information
You likely can't join if
- 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
See the full eligibility criteria
- Cardiac transplant patients for 3 months
- Over 18 years of age
- No DSA at D0 (positive threshold MFI> 2000)
- 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.
- EBV 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.