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A Pilot Trial of Clazakizumab in Late ABMR

NCT03444103 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-09-09

No results posted yet for this study

Summary

This bi-center study (Medical University of Vienna \& Charité Berlin) is an investigator-driven pilot trial designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy (preliminary assessment) of humanized anti-IL-6 monoclonal antibody clazakizumab in kidney transplant recipients with late antibody-mediated rejection (ABMR). The study is designed as a phase 2 trial and has two subsequent sub-parts, a randomized placebo-controlled trial (part A) of 12 weeks, where recipients are allocated to receive either anti-IL-6 antibody clazakizumab (n=10) or placebo (n=10), followed by an open-label prospective study, where all 20 study patients will receive clazakizumab for a period of 40 weeks. Study protocol biopsies will be performed at the end of part A and part B.

Conditions

  • Antibody-mediated Rejection

Interventions

DRUG

Clazakizumab / Clazakizumab

Humanized monoclonal anti-IL-6 antibody

DRUG

Placebo / Clazakizumab

0.9% Saline

Sponsors & Collaborators

  • CSL Behring

    collaborator INDUSTRY

  • University of Alberta

    collaborator OTHER

  • Charite University, Berlin, Germany

    collaborator OTHER

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Bernd Jilma, MD · Department of Clinical Pharmacology, Medical University Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-01-16
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Austria
  • Germany

Study Locations

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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 NCT03444103 on ClinicalTrials.gov