TocIlizumab in Late/Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients (NCT04561986) | Clinical Trial Compass
RecruitingPhase 3
TocIlizumab in Late/Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients
Spain, Sweden50 participantsStarted 2022-02-01
Plain-language 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 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.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. 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
✓. Biopsy-proven diagnosis of late active or chronic active ABMR (≥ 6 months after transplantation) according to the Banff 2022 criteria in index biopsy
✓. eGFR ≥20 ml/min/1.73 m2
✓. Epstein-Barr Virus (EBV) IgG-positive
✓. For female participants of childbearing potential:
Exclusion criteria
✕. 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
✕. History of recurrent infections requiring hospitalization