Kidney Transplantation
Conditions
Keywords
Transplantation, Kidney, calcineurin inhibitor, NFAT, tacrolimus
Brief summary
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.
Detailed description
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.
Interventions
OTHERDose adjust group (NFAT)
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%.
Sponsors
Astellas Pharma Inc
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
Any patient not maintained on triple therapy with tacrolimus, mycophenolate mofetil and steroids and/or who had evidence of rejection on 6- month management biopsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Number of adjustments made to tacrolimus regimen at 6 months; •Lack of correlation between NFAT-dependent cytokine expression and tacrolimus trough levels | 6 Months |
Secondary
| Measure | Time frame |
|---|---|
| 1 year (18 months post-transplant) biopsy proven acute rejections episodes | 12 Months |
| 1 year (18 months post-transplant) cumulative infectious complications | 12 Months |
| 1 year (18 months post-transplant) GFR | 12 Months |
| 1 year (18 months post-transplant) allograft survival | 12 Months |
| 1 year (18 months post-transplant) patient survival | 12 Months |
Countries
United States
Outcome results
None listed