NCT05338177

Pilot Trial on Immunosuppression Modulation to Increase SARS-CoV-2 Vaccine Response in Kidney Transplant Recipients

Pilot Trial on Immunosuppression Modulation in Kidney Transplant Recipients Without SARS-CoV-2 Spike Protein Antibodies Following Full Vaccination

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-11-15
• Primary completion: 2022-01-15
• Completion: 2022-11-14
• First posted: 2022-04-21
• Last updated: 2022-04-21

Locations

1 site across 1 country: Austria