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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2028
  • participants needed
    350
  • sponsor
    CSL Behring
Updated on 1 March 2021

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 on1 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Antibody Mediated Rejection??
Age 18-70 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 6 months (+3 weeks) of the start of the screening
period, the biopsy and DSA analysis do 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 2 weeks after the end of any
prior treatment for ABMR (including CABMR) or TCMR, in order to show
continuing CABMR and presence of HLA DSA. In addition, treatments for ABMR or
TCMR are not allowed within 3 months of the start of screening
The following histopathologic and serologic diagnostic criteria (based on
Banff 2015 criteria [Loupy et al, 2017]) must be met for inclusion
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
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
Treatment for ABMR (including CABMR) or TCMR within 3 months of the start of screening
Received T cell depleting agents (e.g., alemtuzumab, anti-thymocyte globulin) within 3 months of the start of screening
Pregnant, breastfeeding, or unwillingness to practice adequate contraception
History of active tuberculosis (TB)
History of human immunodeficiency virus (HIV) infection or positive for HIV
Seropositive for hepatitis B surface antigen (HBsAg)
Hepatitis C virus (HCV) RNA positive
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