Clinical Research Directory
Browse clinical research sites, groups, and studies.
TocIlizumab in Late/Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients
Sponsor: Vastra Gotaland Region
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.
Official title: A Randomized Controlled Open-label Multi-center Study to Assess the Efficacy of TCZ in Treatment of Late/Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2022-02-01
Completion Date
2028-12
Last Updated
2025-04-03
Healthy Volunteers
No
Conditions
Interventions
Tocilizumab
Tocilizumab is a recombinant humanized monoclonal antibody directed against the human interleukin-6 (IL-6) receptor
Locations (8)
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
Hospital del Mar
Barcelona, Spain
Marqués de Valdecilla Research Institute
Santander, Spain
Hospital Universitario Dr. Peset
Valencia, Spain
Skåne University Hospital
Malmo, Skåne County, Sweden
Transplant Center, Sahlgrenska University Hospital
Gothenburg, Vastra Gotaland Regioin, Sweden
Karolinksa University Hospital
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden