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Table 2 Study inclusion and exclusion criteria

From: Valaciclovir to prevent Cytomegalovirus mediated adverse modulation of the immune system in ANCA-associated vasculitis (CANVAS): study protocol for a randomised controlled trial

Inclusion criteria  
  Documented diagnosis of granulomatosis with polyangiitis (Wegener’s), microscopic polyangiitis or renal limited vasculitis according to Chapel Hill Consensus Conference Criteria
  In stable remission (no documented clinical disease activity) for at least 6 months prior to study entry
  On maintenance immunosuppression with prednisolone, mycophenolate mofetil or azathioprine alone or in combination (maximum two agents)
  Documented past evidence (any time point) of CMV infection (CMV-specific immunoglobulin G detected in peripheral blood)
  Documentation that female patients of child-bearing potential are not pregnant and are using an appropriate form of contraception
  Written informed consent for study participation
Exclusion criteria  
  Stage 5 CKD (estimated glomerular filtration rate (eGFR) <15 ml minute-1 1.73 m-2); tests performed within 6 months of pre-baseline visit can be used for this assessment
  Other significant chronic infection (HIV, hepatitis B, hepatitis C or tuberculosis)
  B-cell depleting therapy within 12 months or T-cell depleting therapy within 6 months
  Treatment with anti-CMV therapies in the last month
  Underlying medical conditions, which in the opinion of the investigator place the patient at unacceptably high risk for participating in the study
  Inability to participate fully or appropriately in the study