A Pilot Trial of Clazakizumab in Late ABMR

Sponsor
Medical University of Vienna
Study ID
NCT03444103
Phase
PHASE2
Status
Completed

Conditions

  • Antibody-mediated Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 16, 2018
Status verified
Sep 2020
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Clazakizumab / Clazakizumab
    Monthly subcutaneous injections of 25mg clazakizumab for three months (after completion of part A, monthly injection of 25mg clazakizumab for nine months).
  • Placebo Comparator: Placebo / Clazakizumab
    Monthly subcutaneous injections of placebo (saline) for three months (after completion of part A, monthly injection of 25mg clazakizumab for nine months).

Primary Outcome Measure

Number of adverse events and severe adverse events (AE's, SAE's) [ Time Frame: 12 months ]

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