Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT06291103
Eligibility Criteria:
Inclusion Criteria:
1. Screening inclusion criteria:
* Kidney transplant recipient
* Adult
* De novo DSA (MFI \> 1000 using the Luminex single antigen beads assay or positive with the manufacturer criteria according to the Luminex assay) absent on the day of kidney transplantation and in the sera prior to kidney transplantation
* No clinical graft dysfunction at time of DSA detection (\< 20 % variation of eGFR compared to last 3 months before detection and \< 0,5 g/g proteinuria/creatinuria ratio)
* Affiliation with, or beneficiary of a Social security (national health insurance) category
* Person having read and understood the information letter and signed the consent form
* Women of childbearing potential with effective contraception/very-effective contraception (Cf. CTFG) (oestro-progestatives or intra-uterine device or tubal ligation) and a negative blood pregnancy test.
* Women surgically sterile (absence of ovaries and/or uterus)
* Postmenopausal women: confirmation diagnostic (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)
2. Randomization inclusion criteria:
* Patients with active sABMR, according Banff 2019 classification, with very slight transplant glomerulogathy (cg = 0 or 1).
Exclusion Criteria:
1. Screening exclusion criteria:
* Minor
* Specific treatment for DSA occurrence before kidney graft biopsy: IVIG or rituximab or plasmapheresis or immunoabsorption
* ABO incompatible kidney transplantation
* Combined transplantation
* Transplant recipients who are Epstein-Barr virus (EBV) seronegative or serostatus unknown.
* Hypersensitivity to the active substance or to any of the excipients - Pregnant or parturient or breastfeeding woman or absence of contraception
* Person deprived of liberty by an administrative or judiciary decision or person placed under judicial protection, under guardianship or supervision
* Person consenting to the research participating to another trial
* Medical history or psychological or sensorial abnormality prone to inhibit the subject to understand the conditions required for his/her participation to the protocol or unable him/her to give an informed consent
* No signed ICF
2. Randomization exclusion criteria:
* No sABMR or chronic active sABMR (cg \> 1) on initial biopsy
* History of severe opportunistic infection before randomization
* Acute or chronic infection with HBV, HCV or HIV
* EBV negative serology
* History of post-transplant lymphoproliferative disorder.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06291103
Study Brief:
Protocol Section:
NCT06291103