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TocIlizumab in Chronic Antibody-mediated Rejection in Kidney Transplant Recipients — INTERCEPT  

Antibody-mediated Rejection Clinical Trial

Official title:
A Randomized Controlled Open-label Multi-center Study to Assess the Efficacy of TCZ in Treatment of Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients

Clinical Trial 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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04561986
Study type Interventional
Source Vastra Gotaland Region
Contact Seema Baid-Agrawal, MD, FASN
Phone +4631-342 10 00
Email seema.baid-agrawal@vgregion.se
Status Recruiting
Phase Phase 3
Start date February 1, 2022
Completion date December 2027
View Details
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