Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant… (NCT03744910) | Clinical Trial Compass
TerminatedPhase 3
Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients
Stopped: Early stop for lack of efficacy/futility (at Interim analysis)
United States194 participantsStarted 2019-10-14
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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. For eligibility, kidney biopsy must not be older than 12 months and DSA analysis must be performed no longer than 6 months prior to the start of Screening.
Exclusion criteria
✕. Morphologic evidence of chronic tissue injury, as demonstrated by transplant glomerulopathy (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:
✕. Written informed consent obtained from subject (or legally acceptable representative) before any trial-related procedures.
✕. 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 prior to the start of screening with the exception of steroids.
✕. Received T cell depleting agents (e.g., alemtuzumab, anti-thymocyte globulin) within 3 months prior to the start of screening.
✕. Pregnant, breastfeeding, or unwillingness to practice adequate contraception.
What they're measuring
1
Change From Baseline to Week 52 in Estimated Glomerular Filtration Rate (eGFR)
Timeframe: From Baseline to Week 52
2
Number of Participants With Composite All-cause Allograft Loss or Irreversible Loss of Allograft Function
Timeframe: From Baseline to 4 years
3
Percentage of Participants With Composite All-cause Allograft Loss or Irreversible Loss of Allograft Function
Timeframe: From Baseline to 4 years
4
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and Adverse Events of Special Interest (AESIs)
Timeframe: Up to 4 years
5
Percentage of Participants With TEAEs, Serious TEAEs, and AESIs
Timeframe: Up to 4 years
6
Number of Participants Who Tested Positive for Polyoma BK Virus (BKV), Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV)
Timeframe: From baseline up to 4 years
7
Number of Participants With Abnormal Laboratory Test Results