Last reviewed · How we verify

NCT05338177: BOOST_TX_SubA

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

Status unknown Phase 1 Last updated 21 April 2022
What this trial tests

Phase 1 trial testing Immunosuppression reduction in COVID-19 in 40 participants. Status unknown.

Timeline
15 November 2021
Primary endpoint
15 January 2022
14 November 2022

Quick facts

Lead sponsorMedical University of Vienna
PhasePhase 1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment40
Start date15 November 2021
Primary completion15 January 2022
Estimated completion14 November 2022
Sites1 location across Austria

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of Vienna

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Immunosuppression reduction

Trials testing the same drug.

Other recruiting trials for COVID-19

Currently open trials in the same condition.

Other Medical University of Vienna trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05338177.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing