NCT05338177

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_1 covid19

Timeline
Completed

Started Nov 2021

Typical duration for phase_1 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2022

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

April 8, 2022

Last Update Submit

April 16, 2022

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Seroconversion at 4 weeks

    Number of patients developing SARS-CoV-2 antibodies at 4 weeks after vaccination

    4 weeks

Secondary Outcomes (5)

  • Seroconversion at 7 days

    7 days

  • Antibody levels at 4 weeks

    4 weeks

  • Donor specific antibodies

    4 weeks

  • Donor-derived cell free DNA

    4 weeks

  • Creatinine levels

    4 weeks

Study Arms (2)

Immunosuppression reduction

EXPERIMENTAL

Participants stop mycophenolate or azathioprine for two weeks peri-vaccination. Treatment is stopped on week before vaccination and only restarted one week after vaccination

Other: Immunosuppression reduction

No immunosuppression reduction

ACTIVE COMPARATOR

no alterations to immunosuppression

Other: No immunosuppression reduction

Interventions

Immunosuppression reductionOTHER

participants stop mycophenolate or azathioprine one week before additional vaccine dose. Overall medication is stopped for two weeks.

Immunosuppression reduction
No immunosuppression reductionOTHER

participants do not alter immunosuppresion

No immunosuppression reduction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 8, 2022

First Posted

April 21, 2022

Study Start

November 15, 2021

Primary Completion

January 15, 2022

Study Completion

November 14, 2022

Last Updated

April 21, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)