At a glance
ClinicalIndex Comparison RecordN/ACompleted· 50 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Tacrolimus Adjustment by NFAT-related Gene Expression in Lung Allograft Recipients.
In Brief
An observational study for Transplantation, Lung. Completed, enrolled 50 participants across 1 site.
Detailed Summary
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).
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsTransplantation, Lung
CountriesUnited States
CollaboratorsAstellas Scientific & Medical Affairs, Inc.
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartDec 2014
Primary CompletionMay 2017
Study CompletionJan 2018
TodayJul 2026
First PostedOct 30, 2014
Enrollment StartDec 1, 2014
Primary CompletionMay 1, 2017
Study CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 11.7 years ago