Status:
UNKNOWN
Pilot Trial on Immunosuppression Modulation to Increase SARS-CoV-2 Vaccine Response in Kidney Transplant Recipients
Lead Sponsor:
Medical University of Vienna
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 azathiopri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05338177
Start Date
November 15 2021
End Date
November 14 2022
Last Update
April 21 2022
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria, 1090