Mycophenolate has been identified as risk factor for non-response to SARS-CoV-2 vaccination in kidney transplant recipients. Safety and efficacy of temporarily stopping of mycophenolate (or azathioprine) to increase vaccine response has not been established. This is a non-randomized, controlled pilot study including up to 40 kidney transplant recipients not responding to at least three previous SARS-CoV-2 vaccine doses. Mycophenolate or azathioprine will be stopped for two weeks peri-vaccination starting one week before vaccination until one week after vaccination. Allocation to mycophenoalte or azathioprine discontinuation arm will be based on an overall risk assessment by the transplant physician and patient preference. Patients not stopping mycophenolate or azathioprine will serve as control group.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
participants stop mycophenolate or azathioprine one week before additional vaccine dose. Overall medication is stopped for two weeks.
participants do not alter immunosuppresion
Medical University of Vienna
Vienna, Austria
Seroconversion at 4 weeks
Number of patients developing SARS-CoV-2 antibodies at 4 weeks after vaccination
Time frame: 4 weeks
Seroconversion at 7 days
Number of patients developing SARS-CoV-2 antibodies at 7 days after vaccination
Time frame: 7 days
Antibody levels at 4 weeks
SARS-CoV-2 antibody levels at 4 weeks after vaccination
Time frame: 4 weeks
Donor specific antibodies
Donor specific antibodies at 4 weeks after mycophenolate / azathioprine pausing
Time frame: 4 weeks
Donor-derived cell free DNA
Donor-derived at 4 weeks after mycophenolate / azathioprine pausing
Time frame: 4 weeks
Creatinine levels
Creatinine levels at 4 weeks after mycophenolate / azathioprine pausing
Time frame: 4 weeks
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