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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