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

NCT05338177 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-04-21

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2022-01-15
Completion
2022-11-14

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05338177 on ClinicalTrials.gov