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Fig. 2 | Trials

Fig. 2

From: Clazakizumab for the treatment of chronic active antibody-mediated rejection (AMR) in kidney transplant recipients: Phase 3 IMAGINE study rationale and design

Fig. 2

IMAGINE study schedule of events for year 1. aAEs occurring during the Screening Period are to be recorded as Medical History. Any AE that meets the definition of a SAE must also be reported to CSL Behring (or its delegate: e.g., CRO) within 24 h of site awareness. AE, adverse event; BKV, polyoma BK virus; BL, baseline; CBC, complete blood count; CMV, cytomegalovirus; CNI, calcineurin inhibitor; DSA, donor-specific antibodies; EBV, Epstein–Barr virus; ECG, electrocardiogram; eGFR, estimated glomerular fibrillation rate; EOT, end of treatment; EQ-5D-5L, EuroQOL-5 dimensions, 5 levels questionnaire; FACIT, Functional Assessment of Chronic Illness Therapy; hsCRP, high-sensitivity C-reactive protein; IgG, immunoglobulin G; IL-6, interleukin-6; KDQoL-36, Kidney Disease Quality of Life 36-Item Short-Form Survey; MFI, mean fluorescence intensity; MMF, mycophenolate mofetil; MPA, mycophenolic acid; PCR, polymerase chain reaction; Q4W; once every 4 weeks; SAE, serious AE; SC, subcutaneous; UACR, urine albumin-to-creatinine ratio; wk, week

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