NCT01771705

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

May 2, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2017

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

3.3 years

First QC Date

January 16, 2013

Last Update Submit

May 15, 2020

Conditions

Kidney Transplantation

Keywords

TransplantationKidneycalcineurin inhibitorNFATtacrolimus

Outcome Measures

Primary Outcomes (1)

  • •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 Outcomes (5)

  • 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) GFR

    12 Months

  • 1 year (18 months post-transplant) allograft survival

    12 Months

  • 1 year (18 months post-transplant) patient survival

    12 Months

Study Arms (2)

Dose adjust group (NFAT)

EXPERIMENTAL

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%.

Other: Dose adjust group (NFAT)

Standard of care group

NO INTERVENTION

A CNI trough level will be obtained. Adjustments of CNI will be based on target trough drug levels as per standard of care.

Interventions

Dose adjust group (NFAT)OTHER

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%.

Dose adjust group (NFAT)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (7)

  • Giese T, Sommerer C, Zeier M, Meuer S. Monitoring immunosuppression with measures of NFAT decreases cancer incidence. Clin Immunol. 2009 Sep;132(3):305-11. doi: 10.1016/j.clim.2009.03.520. Epub 2009 Apr 23.

    PMID: 19398376RESULT

  • Giese T, Zeier M, Schemmer P, Uhl W, Schoels M, Dengler T, Buechler M, Meuer S. Monitoring of NFAT-regulated gene expression in the peripheral blood of allograft recipients: a novel perspective toward individually optimized drug doses of cyclosporine A. Transplantation. 2004 Feb 15;77(3):339-44. doi: 10.1097/01.TP.0000109260.00094.01.

    PMID: 14966405RESULT

  • Sommerer C, Giese T, Schmidt J, Meuer S, Zeier M. Ciclosporin A tapering monitored by NFAT-regulated gene expression: a new concept of individual immunosuppression. Transplantation. 2008 Jan 15;85(1):15-21. doi: 10.1097/01.tp.0000296824.58884.55.

    PMID: 18192906RESULT

  • Sommerer C, Zeier M, Meuer S, Giese T. Individualized monitoring of nuclear factor of activated T cells-regulated gene expression in FK506-treated kidney transplant recipients. Transplantation. 2010 Jun 15;89(11):1417-23. doi: 10.1097/TP.0b013e3181dc13b6.

    PMID: 20463649RESULT

  • Hartmann B, Schmid G, Graeb C, Bruns CJ, Fischereder M, Jauch KW, Heeschen C, Guba M. Biochemical monitoring of mTOR inhibitor-based immunosuppression following kidney transplantation: a novel approach for tailored immunosuppressive therapy. Kidney Int. 2005 Dec;68(6):2593-8. doi: 10.1111/j.1523-1755.2005.00731.x.

    PMID: 16316335RESULT

  • Leogrande D, Teutonico A, Ranieri E, Saldarelli M, Gesualdo L, Schena FP, Di Paolo S. Monitoring biological action of rapamycin in renal transplantation. Am J Kidney Dis. 2007 Aug;50(2):314-25. doi: 10.1053/j.ajkd.2007.05.002.

    PMID: 17660033RESULT

  • Belouski SS, Wilkinson J, Thomas J, Kelley K, Wang SW, Suggs S, Ferbas J. Utility of lyophilized PMA and ionomycin to stimulate lymphocytes in whole blood for immunological assays. Cytometry B Clin Cytom. 2010 Jan;78(1):59-64. doi: 10.1002/cyto.b.20492.

    PMID: 19777549RESULT

Study Officials

  • Flavio Vincenti, M.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Allison Webber, M.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 18, 2013

Study Start

May 2, 2013

Primary Completion

August 13, 2016

Study Completion

April 17, 2017

Last Updated

May 21, 2020

Record last verified: 2020-05

Locations

US(1)