Overview

This trial is active, not recruiting.

Condition kidney transplantation
Treatment dose adjust group (nfat)
Sponsor University of California, San Francisco
Collaborator Astellas Pharma Inc
Start date April 2013
End date December 2016
Trial size 40 participants
Trial identifier NCT01771705, NFAT dependent cytokines

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Within 2 weeks of a 6 month management biopsy, if eligibility is confirmed, NFAT dependent cytokines including IL-2, IFNg, and GMCSF at times C0 and C1.5 will be performed with the residual expression calculated based on the ratio of C1.5/C0 x 100%. If the average residual expression of the 3 cytokines is <15%, the CNI daily dose will be reduced by 15%. If the average residual gene expression of the 3 cytokines is > 80% the CNI daily dose will be increased by 15%.
dose adjust group (nfat)
If the average residual expression of the 3 cytokines is <15%, the CNI daily dose will be reduced by 15%. If the average residual gene expression of the 3 cytokines is > 80% the CNI daily dose will be increased by 15%.
(No Intervention)
A CNI trough level will be obtained. Adjustments of CNI will be based on target trough drug levels as per standard of care.

Primary Outcomes

Measure
•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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title NFAT-Dependent Cytokine Gene Expression for Immune Monitoring in Kidney Transplant Patients
Principal investigator Flavio Vincenti, M.D.
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 2 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of California, San Francisco.