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 late or chronic antibody-mediated rejection (AMR). 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 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.
The subject has given their written informed consent to participate in the study
Recipient of living donor or deceased donor kidney transplant
Age ≥18 years
At least 6 months post-transplantation at randomization
Recipient of multi-organ transplants
De novo or recurrent renal disease that is considered to be the predominant cause of the current graft dysfunction
Active viral infections such as BK virus (BKV), cytomegalovirus (CMV), EBV, COVID-19, hepatitis C virus (HCV) or hepatitis B virus (HBV) infections based on polymerase chain reaction (PCR) testing
Ongoing serious infections as per Investigator's opinion
Vastra Gotaland Region
Lead sponsor
Karolinska University Hospital
Collaborator
Uppsala University Hospital
Collaborator
Skane University Hospital
Collaborator
The Swedish Research Council
Collaborator
Hospital del Mar
Collaborator
Hospital Universitario Doctor Peset
Collaborator
Complexo Hospitalario Universitario de A Coruña
Collaborator
Hospital Universitario Marqués de Valdecilla
Collaborator