eligibility_summary
Eligibility: Adults (>18) with ESRD on dialysis/CKD V, candidates for pre-transplant desensitization. Women of childbearing age: negative pregnancy test and highly effective contraception. Must consent, have social security, and be reachable. Controls: healthy blood donors and highly sensitized transplant recipients (PRA>85%) not needing de-immunization. Exclude: refusal, immunosuppression in past 12 mo, protected persons, other study/exclusion, under supervision, unreachable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial type: observational comparison of desensitized vs non‑desensitized highly sensitized kidney transplant recipients (plus healthy donors). Interventions under study: desensitization using apheresis (therapeutic plasma exchange/immunoadsorption, procedure) and an anti‑CD20 monoclonal antibody (biologic) given pre‑transplant. Mechanisms: apheresis physically removes circulating anti‑HLA antibodies, anti‑CD20 mAb depletes CD20+ B cells to blunt humoral memory and donor‑specific antibody production. Targets assessed: CD20+ B cells, memory B cells, antibody‑secreting cells/plasmablasts/plasma cells, HLA‑specific humoral responses (B‑cell anti‑HLA ELISpot), immuno‑metabolic B‑cell phenotypes (flow cytometry), and renal parenchyma immune gene expression (Nanostring on biopsies).