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

Phase 1

• Conditions: COVID-19
• Interventions: Other: Immunosuppression reduction; Other: No immunosuppression reduction

• Registration Number: NCT05338177
• Lead Sponsor: Medical University of Vienna

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-15
• Primary Completion: 2022-01-15
• Status Verified: 2022-04
• Study First Submitted: 2022-04-08
• Study First Submitted QC: 2022-04-16
• Last Update Submitted: 2022-04-16
• Study First Posted: 2022-04-21
• Last Update Posted: 2022-04-21
• Study Completion: 2022-11-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immunosuppression reduction	Immunosuppression reduction	Participants stop mycophenolate or azathioprine for two weeks peri-vaccination. Treatment is stopped on week before vaccination and only restarted one week after vaccination
No immunosuppression reduction	No immunosuppression reduction	no alterations to immunosuppression

Primary Outcome Measures

Name	Time	Method
Seroconversion at 4 weeks	4 weeks	Number of patients developing SARS-CoV-2 antibodies at 4 weeks after vaccination

Secondary Outcome Measures

Name	Time	Method
Antibody levels at 4 weeks	4 weeks	SARS-CoV-2 antibody levels at 4 weeks after vaccination
Donor specific antibodies	4 weeks	Donor specific antibodies at 4 weeks after mycophenolate / azathioprine pausing
Donor-derived cell free DNA	4 weeks	Donor-derived at 4 weeks after mycophenolate / azathioprine pausing
Seroconversion at 7 days	7 days	Number of patients developing SARS-CoV-2 antibodies at 7 days after vaccination
Creatinine levels	4 weeks	Creatinine levels at 4 weeks after mycophenolate / azathioprine pausing

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria