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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of California, San Francisco
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01771705
First received: January 16, 2013
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

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 Intervention
Kidney Transplantation
Other: Dose adjust group (NFAT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: NFAT-Dependent Cytokine Gene Expression for Immune Monitoring in Kidney Transplant Patients

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • •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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1 year (18 months post-transplant) biopsy proven acute rejections episodes [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
  • 1 year (18 months post-transplant) cumulative infectious complications [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
  • 1 year (18 months post-transplant) GFR [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
  • 1 year (18 months post-transplant) allograft survival [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
  • 1 year (18 months post-transplant) patient survival [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771705

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Flavio Vincenti, M.D.    415-353-1322    Flavio.Vincenti@ucsfmedctr.org   
Contact: Allison Webber, M.D.    415-353-1290    Allison.Webber@ucsfmedctr.org   
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
  More Information

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01771705     History of Changes
Other Study ID Numbers: NFAT dependent cytokines
Study First Received: January 16, 2013
Last Updated: May 3, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 18, 2014