N/A
Completed N=50
Tacrolimus Adjustment by NFAT-related Gene Expression in Lung Allograft Recipients.
Transplantation, Lung
Source: ClinicalTrials.gov NCT02278952 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Association of Percentage of Mean Residual Expression (MRE%) of NFAT-related Cytokine Expression and Acute Cellular Rejection — 39.5; 41.7 percentage of mean residual expression — p=0.33
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Association of Percentage of Mean Residual Expression (MRE%) of NFAT-related Cytokine Expression and Acute Cellular Rejection |
39.5; 41.7 | 0.33 |
| PRIMARY Association of Percentage of Mean Residual Expression (MRE%) of NFAT-related Cytokine Expression and Infection |
14.4; 22.2 | < 0.0001 sig |
| SECONDARY Association of Percentage of Mean Residual Expression (MRE%) of NFAT-related Cytokine Expression and Weeks Post-Transplant |
0.35 | 0.049 sig |
| SECONDARY Association of Percentage of Mean Residual Expression (MRE%) of NFAT-related Cytokine Expression and Tacrolimus Trough Level |
-1.687 | 0.114 |
| SECONDARY Association of Percentage of Mean Residual Expression (MRE%) of NFAT-related Cytokine Expression and Medication Dosages |
0.676; -1.687; -0.0035 | 0.470 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02278952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.