The purpose of this study is to compare two different ways of monitoring the immune system to determine how to manage the doses of anti-rejection medications.
This is a single center randomized controlled trial investigating the efficacy and safety of adjusting calcineurin inhibitor (CNI) dosing based on Nuclear Factor of Activating T Cells (NFAT)-dependent cytokine gene expression as compared to standard of care adjustments based on trough level. Before any study-related evaluations are performed, the patient must give written informed consent. Once consent is obtained, a patient's eligibility to participate in the study will be assessed within 4 weeks of their 6 month management biopsy. Approximately 40 patients who meet inclusion criteria will be randomized at University of California, San Francisco (UCSF). Eligible patients include any patient maintained on triple therapy with tacrolimus, mycophenolate mofetil ,and prednisone who has had no prior rejection episodes and who has undergone a 6 month management kidney biopsy that shows no evidence of acute cellular rejection or antibody mediated rejection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
If the average residual expression of the 3 cytokines is \<20%, the CNI daily dose will be reduced by 15%. If the average residual gene expression of the 3 cytokines is \> 60% the CNI daily dose will be increased by 15%.
University of California, San Francisco
San Francisco, California, United States
•Number of adjustments made to tacrolimus regimen at 6 months; •Lack of correlation between NFAT-dependent cytokine expression and tacrolimus trough levels
Time frame: 6 Months
1 year (18 months post-transplant) biopsy proven acute rejections episodes
Time frame: 12 Months
1 year (18 months post-transplant) cumulative infectious complications
Time frame: 12 Months
1 year (18 months post-transplant) GFR
Time frame: 12 Months
1 year (18 months post-transplant) allograft survival
Time frame: 12 Months
1 year (18 months post-transplant) patient survival
Time frame: 12 Months
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