A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients (IMAGINE)

  • STATUS
    Recruiting
  • End date
    Feb 25, 2030
  • participants needed
    350
  • sponsor
    CSL Behring
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Updated on 25 October 2022
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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.

Details
Condition Antibody-mediated Rejection
Treatment Normal saline, Clazakizumab, Physiologic saline solution
Clinical Study IdentifierNCT03744910
SponsorCSL Behring
Last Modified on25 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 18-75 years
Living donor/deceased donor kidney transplant recipients ≥6 months from time of transplant
Diagnosis of CABMR determined by kidney biopsy and the presence of HLA DSA using single-antigen bead-based assays
NOTE: If conducted within 12 months (+3 weeks) prior to the start of the
screening period, and no intervening treatments have been administered, the
biopsy does not need to be repeated at Screening. If conducted within 6 months
(+ 3 weeks) prior to the start of Screening, the DSA analysis does not need to
be repeated at screening. To be considered for determination of study
eligibility, the biopsy and DSA analysis must be performed at least 2 months ±
weeks after the end of any prior treatment for ABMR (including CABMR) or
The following histopathologic and serologic diagnostic criteria (based on
TCMR, in order to show continuing CABMR and presence of HLA DSA. In addition
Banff 2015 criteria [Loupy et al, 2017]) must be met for inclusion
with the exception of steroids, treatments for ABMR or TCMR are not allowed
Morphologic evidence of chronic tissue injury, as demonstrated by TG (cg>0). Biopsies without evidence of chronic tissue injury on light microscopy, but with glomerular basement membrane double contours on electron microscopy (cg1a) are eligible
within 3 months prior to the start of screening
Evidence of current/recent antibody interaction with vascular endothelium, including 1 or more of the following
Linear C4d staining in peritubular capillaries or medullary vasa recta (C4d2 or C4d3 by immunofluorescence on frozen sections, or C4d > 0 by immunohistochemistry on paraffin sections)
At least moderate microvascular inflammation ([g + ptc] ≥ 2) in the absence of recurrent or de novo glomerulonephritis, although in the presence of acute TCMR, borderline infiltrate, or infection, ptc ≥ 2 alone is not sufficient and g must be ≥ 1
NOTE: The local pathologist's diagnosis must be reviewed by a central pathologist
to confirm eligibility for entry into the study. Biopsies with other
histopathologic changes (eg, BKV nephropathy or recurrent glomerulonephritis) may
be eligible if concurrent CABMR changes (as detailed above) are present and
determined to be the predominant cause of renal dysfunction
Serologic evidence of circulating DSA to HLA. NOTE: The local laboratory DSA
results must be reviewed and confirmed by the central HLA reviewer during the
screening period

Exclusion Criteria

Multi-organ transplant recipient (except for simultaneous kidney-pancreas or
previous multiple kidney transplants) or cell transplant (islet, bone marrow
stem cell) recipient
Pregnant, breastfeeding, or unwillingness to practice adequate contraception
Received T cell depleting agents (e.g., alemtuzumab, anti-thymocyte globulin)
History of human immunodeficiency virus (HIV) infection or positive for HIV
Treatment for ABMR (including CABMR) or TCMR within 3 months prior to the start
Seropositive for hepatitis B surface antigen (HBsAg)
of screening with the exception of steroids
Hepatitis C virus (HCV) RNA positive
within 3 months prior to the start of screening
Active tuberculosis (TB) or history of active TB
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