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

COVID-19 Clinical Trial

— BOOST_TX_SubA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05338177
• Other study ID #: BOOST_TX_SubA
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 15, 2021
• Est. completion date: November 14, 2022

Study information

• Verified date: April 2022
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: November 14, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Immunosuppression reduction
participants stop mycophenolate or azathioprine one week before additional vaccine dose. Overall medication is stopped for two weeks.
• No immunosuppression reduction
participants do not alter immunosuppresion

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion at 4 weeks	Number of patients developing SARS-CoV-2 antibodies at 4 weeks after vaccination	4 weeks
Secondary	Seroconversion at 7 days	Number of patients developing SARS-CoV-2 antibodies at 7 days after vaccination	7 days
Secondary	Antibody levels at 4 weeks	SARS-CoV-2 antibody levels at 4 weeks after vaccination	4 weeks
Secondary	Donor specific antibodies	Donor specific antibodies at 4 weeks after mycophenolate / azathioprine pausing	4 weeks
Secondary	Donor-derived cell free DNA	Donor-derived at 4 weeks after mycophenolate / azathioprine pausing	4 weeks
Secondary	Creatinine levels	Creatinine levels at 4 weeks after mycophenolate / azathioprine pausing	4 weeks