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RECRUITING
NCT04561986
PHASE3

TocIlizumab in Late/Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients

Sponsor: Vastra Gotaland Region

View on ClinicalTrials.gov

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

Interventions

DRUG

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