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Table 2 The SPIRIT figure

From: Tocilizumab in chronic active antibody-mediated rejection: rationale and protocol of an in-progress randomized controlled open-label multi-center trial (INTERCEPT study)

  1. AE Adverse events, CMV Cytomegalovirus, EBV Ebstein–Barr virus, m month, PCR Polymerase chain reaction, SAE Serious adverse events, w week
  2. † Local = regional outpatient clinic or at SU
  3. ‡Done prior to visit 1, as part of pre-screening
  4. §Without urine
  5. 1Including also collection of information about baseline pretransplant characteristics, transplant-related characteristics and review of previous biopsies
  6. 2Physical examination by a physician that includes weight, height, body mass index, vital signs
  7. 3Only for women of childbearing potential (urine)
  8. 4Laboratory analysis 1: haemoglobin, complete and differential white blood counts, platelet count, glucose, creatinine (eGFR), urea, sodium, potassium, liver transaminases, bilirubin, alkaline phosphatase, fibrinogen, tacrolimus concentration, C-reactive protein, urine dipstick, UACR;
  9. 5Laboratory analysis 2: serum electrophoresis
  10. 6Laboratory analysis 3: fasting lipid profile, DSA, T-lymphocytes cell count and subsets (CD4, CD8, memory and naive CD4/CD8, T-regs CD4), B-lymphocyte cell count, peripheral blood mononuclear cells (PBMCs), ABO-antibody titer (in ABO-incompatible transplants), total IgG, tetanus IgG
  11. 7Viral test 1: CMV, BKV, by PCR
  12. 8Viral test 2: HBV, HCV, EBV by PCR, HBsAg
  13. 9Only if patient has symptoms suggestive of COVID-19
  14. 10APTT and INR will be done before the biopsy (2.7 ml blood required)
  15. 11Only for those whose last biopsy will be older than 12 months at randomization
  16. 12From protocol biopsy if done during visit 1
  17. 13Organ Transplant Symptoms and Well-being Instrument (OTSWI), Basel Assessment of Adherence with Immunosuppressive medication Scales (BAASIS©), Perceived Threat of the risk of Graft Rejection (PTGR)
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ISSN: 1745-6215