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Summary

for people ages 18–80 (full criteria)
at San Francisco, California
study started
estimated completion:

Description

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.

Details

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.

Keywords

Kidney Transplantation Transplantation Kidney calcineurin inhibitor NFAT tacrolimus

Eligibility

You can join if…

Open to people ages 18–80

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.

You CAN'T join if...

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.

Location

  • University of California, San Francisco
    San Francisco, California, 94143, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT01771705
Lead Scientists
Flavio Vincenti
Allison Webber
Study Type
Interventional
Last Updated
May 2016