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Kidney TransplantationNCT01771705

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

A study testing Dose adjust group (NFAT) in people with Kidney Transplantation, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Kidney Transplantation
What is being tested?
Dose adjust group (NFAT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
2 May 2013to 17 Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

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.

Read the 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.

Being tested
Dose adjust group (NFAT)
Keywords
Transplantation, Kidney, calcineurin inhibitor, NFAT, tacrolimus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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%.

Study groups in NCT01771705
Study groupRoleWhat they receive
Dose adjust group (NFAT)ExperimentalWithin 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%.
Receives: Other: Dose adjust group (NFAT)
Standard of care groupNo interventionA CNI trough level will be obtained. Adjustments of CNI will be based on target trough drug levels as per standard of care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. •Number of adjustments made to tacrolimus regimen at 6 months; •Lack of correlation between NFAT-dependent cytokine expression and tacrolimus trough levels

    Measured: 6 Months

Secondary outcomes (5)

  1. 1 year (18 months post-transplant) biopsy proven acute rejections episodes

    Measured: 12 Months

  2. 1 year (18 months post-transplant) cumulative infectious complications

    Measured: 12 Months

  3. 1 year (18 months post-transplant) GFR

    Measured: 12 Months

  4. 1 year (18 months post-transplant) allograft survival

    Measured: 12 Months

  5. 1 year (18 months post-transplant) patient survival

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2013 (estimated)
  2. Study start2 May 2013
  3. Primary completion13 Aug 2016
  4. Study completion17 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01771705
Sponsor's protocol ID
NFAT dependent cytokines
Status last verified
May 2020
First submitted
16 Jan 2013
Last updated
21 May 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19398376

  • 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.

    PubMed 14966405

  • 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.

    PubMed 18192906

  • 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.

    PubMed 20463649

  • 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.

    PubMed 16316335

  • 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.

    PubMed 17660033

  • 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.

    PubMed 19777549

Questions about this trial

What is this clinical trial studying?

A study testing Dose adjust group (NFAT) in people with Kidney Transplantation, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

•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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01771705, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.

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