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

Not Applicable

Completed

• Conditions: Kidney Transplantation
• Interventions: Other: Dose adjust group (NFAT)

• Registration Number: NCT01771705
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Study Start: 2013-05-02
• Primary Completion: 2016-08-13
• Study Completion: 2017-04-17
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-15
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose adjust group (NFAT)	Dose adjust group (NFAT)	Within 4 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 \<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%.

Primary Outcome Measures

Name	Time	Method
•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 Outcome Measures

Name	Time	Method
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) allograft survival	12 Months
1 year (18 months post-transplant) patient survival	12 Months
1 year (18 months post-transplant) GFR	12 Months

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States