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Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients

NCT03744910 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2025-07-23

Study results available
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Summary

This trial investigates the efficacy and safety of clazakizumab \[an anti-interleukin (IL)-6 monoclonal antibody (mAb)\] for the treatment of CABMR in recipients of a kidney transplant.

Conditions

  • Antibody-mediated Rejection

Interventions

BIOLOGICAL

Clazakizumab

Clazakizumab is a genetically engineered humanized immunoglobulin G1 (IgG1) mAb that binds to human IL-6

DRUG

Physiologic saline solution

Normal saline

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Study Director · CSL Behring

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-10-14
Primary Completion
2024-04-08
Completion
2024-04-08
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Netherlands
  • New Zealand
  • South Korea
  • Spain
  • Sweden
  • Taiwan

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 NCT03744910 on ClinicalTrials.gov