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

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ClinicalTrials.gov Identifier: NCT01771705
Recruitment Status : Unknown
Verified May 2016 by University of California, San Francisco.
Recruitment status was:  Active, not recruiting
First Posted : January 18, 2013
Last Update Posted : May 24, 2016
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Other: Dose adjust group (NFAT) Not Applicable

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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: NFAT-Dependent Cytokine Gene Expression for Immune Monitoring in Kidney Transplant Patients
Study Start Date : April 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose adjust group (NFAT)
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%.
Other: 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: Standard of care group
A CNI trough level will be obtained. Adjustments of CNI will be based on target trough drug levels as per standard of care.



Primary Outcome Measures :
  1. •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 Outcome Measures :
  1. 1 year (18 months post-transplant) biopsy proven acute rejections episodes [ Time Frame: 12 Months ]
  2. 1 year (18 months post-transplant) cumulative infectious complications [ Time Frame: 12 Months ]
  3. 1 year (18 months post-transplant) GFR [ Time Frame: 12 Months ]
  4. 1 year (18 months post-transplant) allograft survival [ Time Frame: 12 Months ]
  5. 1 year (18 months post-transplant) patient survival [ Time Frame: 12 Months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771705


Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Astellas Pharma Inc
Investigators
Principal Investigator: Flavio Vincenti, M.D. University of California, San Francisco
Principal Investigator: Allison Webber, M.D. University of California, San Francisco

Publications of Results:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01771705     History of Changes
Other Study ID Numbers: NFAT dependent cytokines
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016

Keywords provided by University of California, San Francisco:
Transplantation
Kidney
calcineurin inhibitor
NFAT
tacrolimus