TocIlizumab in Chronic Antibody-mediated Rejection in Kidney Transplant Recipients
Status:
Not yet recruiting
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
Summary
This multi-center study is an investigator-driven randomized controlled parallel group
open-label clinical trial designed to evaluate the efficacy of addition of anti-IL-6 antibody
tocilizumab (TCZ) to the standard of care (SOC) treatment as compared to the SOC alone in
reducing the decline of graft function in kidney transplant recipients with chronic
antibody-mediated rejection (cAMR). A total of 50 recipients will be allocated to receive
either TCZ (n=25) added to the standard of care (SOC) or SOC alone (n=25) for a period of 24
months. Patients will be followed for an additional 12 months. Protocol kidney graft biopsies
will be performed at baseline, at 12 and 24 months. The primary outcome is the mean rate of
change in graft function as assessed by estimated glomerular filtration rate (eGFR) slope
from baseline to 24 months after start of treatment.
Phase:
Phase 3
Details
Lead Sponsor:
Vastra Gotaland Region
Collaborators:
Karolinska University Hospital The Swedish Research Council Uppsala University Hospital