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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Transplantation, Lung

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02278952

Astellas ISR000990

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.

Trial design