Mycophenolate has been identified as risk factor for non-response to SARS-CoV-2vaccination in kidney transplant recipients. Safety and efficacy of temporarily stoppingof mycophenolate (or azathioprine) to increase vaccine response has not been established.This is a non-randomized, controlled pilot study including up to 40 kidney transplantrecipients not responding to at least three previous SARS-CoV-2 vaccine doses.Mycophenolate or azathioprine will be stopped for two weeks peri-vaccination starting oneweek before vaccination until one week after vaccination. Allocation to mycophenoalte orazathioprine discontinuation arm will be based on an overall risk assessment by thetransplant physician and patient preference. Patients not stopping mycophenolate orazathioprine will serve as control group.
Not Provided
Other: Immunosuppression reduction
participants stop mycophenolate or azathioprine one week before additional vaccine dose.
Overall medication is stopped for two weeks.
Other: No immunosuppression reduction
participants do not alter immunosuppresion
Inclusion Criteria:
- Patient has received a kidney transplantation
- > 18 years of age
- No SARS-CoV-2 spike protein antibodies four weeks after at least three previous
vaccine doses
- Maintenance immunosuppression with mycophenolate or azathioprine
Exclusion Criteria:
- acute illness with fever
- Prior documented infection with SARS-CoV-2
- triple anticoagulation therapy
- Subject is currently enrolled in or has not yet completed at least 30 days since
ending other investigational device or drug trial(s), or subject is receiving other
investigational agent(s)
- Subject has known sensitivity or intolerance to any of the products to be
administered for the purpose of this study
- Subject has any kind of disorder that compromises the ability of the subject to give
written informed consent and/or to comply with the study procedures
- Subject is pregnant or breast feeding
- SARS-CoV-2 spike protein antibodies four weeks after the 3rd last vaccination > 0.8
BAU/mL
Medical University of Vienna
Vienna, Austria
Not Provided