A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Kidney Transplant Failure And Rejection
  • Age: Between 18 years - 70 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects who are living donor/deceased donor kidney transplant recipients =6 months from time of transplant.
    2. Subjects with diagnosis of CABMR (Chronic active antibody-mediated rejection)
    3. Subjects who provide written informed consent

You may not be eligible for this study if the following are true:

    1. Subjects unable to or unwilling to comply with study procedures
    2. Subjects who are multi-organ transplant recipient or cell transplant (islet, bone marrow, stem cell) recipient
    3. Subjects receiving treatment for ABMR (including CABMR) or TCMR within 3 months of the start of screening.
    4. Subjects receiving T cell depleting agents (e.g., alemtuzumab, anti-thymocyte globulin) within 3 months of the start of screening
    5. Subjects receiving treatment with mTOR inhibitors within 4 weeks of the start of screening.
    6. Subjects who have biopsy showing pure TCMR or advanced interstitial fibrosis (ci3), advanced tubular atrophy (ct3), vascular fibrous intimal thickening (cv3) or other significant causes of renal dysfunction
    7. Subject with impaired renal function due to disorders in the transplanted allograft (e.g., renal artery stenosis, hydronephrosis)
    8. eGFR <25 mL/min/1.73 m2 or >65 mL/min/1.73 m2 (MDRD4).
    9. Nephrotic range proteinuria defined as spot urine albumin creatinine ratio (UACR) =2,200 mg/g (=220 mg/mmol). If spot UACR is above defined limits, repeat test on separate day to confirm ineligibility (or collect 24-hour urine to confirm nephrotic range proteinuria (=3.0 g/day)).
    10. Subjects who are pregnant, breastfeeding, or unwillingness to practice adequate contraception (i.e., a highly effective birth or acceptable method of contraception) during the study and for 5 months after last dose of investigational drug.
    11. Subjects with history of anaphylaxis or know hypersensitivity to clazakizumab or to any constituent of the drug product.
    12. Abnormal liver function tests (LFTs) or other significant liver disease.
    13. History of active tuberculosis (TB).
    14. History of latent TB (e.g., positive QuantiFERON-TB test) without history of active TB unless subject has completed a full course of prophylactic treatment.
    15. History of human immunodeficiency virus (HIV) infection or positive for HIV.
    16. Seropositive for hepatitis B surface antigen (HBsAg).
    17. Hepatitis C virus (HCV) RNA positive.
    18. Known Epstein-Barr virus (EBV) mismatch (at time of transplant): donor seropositive, recipient seronegative.
    19. History of gastrointestinal perforation; diverticular disease or diverticulitis; or inflammatory bowel disease.
    20. Neutropenia (<1,000/mm3) or thrombocytopenia (<50,000/mm3).
    21. . Active infections requiring systemic antimicrobial agents and unresolved prior to screening.
    22. History of or current invasive fungal infection or other opportunistic infection, including (but not limited to) the following: a nontuberculous mycobacterial infection, aspergillosis, pneumocystosis, and toxoplasmosis.
    23. Active viral infections such as BKV, CMV, or EBV based on polymerase chain reaction (PCR) testing. Active infection is defined as a test result = lower limit of quantification (LLOQ)
    24. Current or recent (within 3 months) participation in an interventional trial.
    25. Administration of a live vaccine within 6 weeks of the start of screening, including but not limited to the following: Adenovirus, measles, mumps, and rubella, Oral polio, Oral typhoid, Rotavirus, Varicella zoster and Yellow fever
    26. History of alcohol or illicit substance (including marijuana) abuse.
    27. Present or previous (within 3 years) malignancy except for basal cell carcinoma, fully excised squamous cell carcinoma of the skin, or non-recurrent (within 5 years) cervical carcinoma in-situ.
    28. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety or life expectancy of the patient or the quality of the data.
    29. . History of intolerance to trimethoprim and/or sulfamethoxazole.
    30. Prior exposure to clazakizumab, tocilizumab, or other IL-6/IL-6R blockers.
    31. ABO-incompatible transplant recipient.
    32. Severe hypogammaglobulinemia
    33. Prior (within 2 years of the start of screening) exposure to proteasome inhibitors (e.g., bortezomib)
    34. .

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