Tacrolimus Adjustment by NFAT-related Gene Expression in Lung Allograft Recipients.

Completed

Conditions studied: Transplantation, Lung

In brief

This is a non-interventional cohort study to assess a novel assay to detect excessive or insufficient immunosuppression from the drug tacrolimus in lung transplant recipients. The assay measures mean residual expression (MRE) of genes downstream of nuclear factor of activated T cells (NFAT), a transcription factor regulated by tacrolimus. The investigators will assess whether MRE levels identify subjects at risk for rejection (insufficient immunosuppression) or infection (excessive immunosuppression).

Key facts

Study ID

NCT02278952

Run by

University of California, San Francisco

People needed

50

Starts

2014-12-01

Expected to finish

2018-01-01

Last updated by the study team

2019-12-03

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The study will include lung allograft recipients within 2 months of transplantation at UCSF.

You may not qualify if…

• Subjects will be excluded who are (a) unable to provide consent or (b) if treating clinicians do not anticipate subject will start on tacrolimus. Recruitment and enrollment in this study are targeted equally between women and minorities and the study will not exclude any gender or racial/ethnic group. This study does not involve vulnerable populations.

Where it is running

• University of California — San Francisco, California, United States

Full record on ClinicalTrials.gov

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