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

NCT04561986 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-03

No results posted yet for this study

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.

Conditions

  • Antibody-mediated Rejection

Interventions

DRUG

Tocilizumab

Tocilizumab is a recombinant humanized monoclonal antibody directed against the human interleukin-6 (IL-6) receptor

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • Uppsala University Hospital

    collaborator OTHER

  • Skane University Hospital

    collaborator OTHER

  • The Swedish Research Council

    collaborator OTHER_GOV

  • Hospital del Mar

    collaborator OTHER

  • Hospital Universitario Doctor Peset

    collaborator OTHER

  • Complexo Hospitalario Universitario de A Coruña

    collaborator OTHER

  • Hospital Universitario Marqués de Valdecilla

    collaborator OTHER

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Seema Baid-Agrawal, MD, FASN · Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04561986 on ClinicalTrials.gov