NCT01771705

NFAT-Dependent Cytokine Gene Expression for Immune Monitoring in Kidney Transplant Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
OTHER	Dose 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%.

Timeline

• Start date: 2013-05-02
• Primary completion: 2016-08-13
• Completion: 2017-04-17
• First posted: 2013-01-18
• Last updated: 2020-05-21

Locations

1 site across 1 country: United States