NCT02541916

Brief Summary

The purpose of this study is to validate and test a tolerance gene expression profile for the identification of operationally tolerant liver transplant recipients, allowing for the successful withdrawal of immunosuppression without rejection in these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

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

Study Start

First participant enrolled

April 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

6.2 years

First QC Date

September 2, 2015

Last Update Submit

September 29, 2021

Conditions

ImmunosuppressionImmune Tolerance

Keywords

Transplantation ToleranceImmune ToleranceTransplantationLiver TransplantationBiological MarkersGene ExpressionImmunosuppressionImmunologyMultiplex Polymerase Chain ReactionReal-Time Polymerase Chain Reaction

Outcome Measures

Primary Outcomes (1)

  • Validation of Tolerance Gene Expression Profile

    The primary endpoint of this study is the identification and validation of a unique tolerance gene expression profile, consisting of a 6 gene profile, in 3-6 operationally tolerant patients compared to 25 rejecting and 25 healthy controls.

    Enrollment to one year post cessation of immunosuppression

Secondary Outcomes (2)

  • Tolerance gene expression profile in graft versus peripheral blood mononuclear cells (PBMCs)

    Enrollment to one year post cessation of immunosuppression

  • Test of tolerance gene expression profile

    Enrollment to one year post cessation of immunosuppression

Study Arms (1)

Controlled weaning of immunosuppression

EXPERIMENTAL

Participants who are found to have the tolerance gene expression profile during phase 1 of the study will undergo closely monitored immunosuppression weaning during phase 2.

Other: Controlled weaning of immunosuppression

Interventions

Controlled weaning of immunosuppressionOTHER

At week 0 patients have liver biopsy and liver functional tests (LFTs). Week 1-4 medication reduction to 1.5mg Tacrolimus (Tac) daily or 150mg Cyclosporine A (CsA). At week 4 LFTs. Week 5-8 medication reduction to 1mg Tac / 100mg CsA. Week 8 LFTs. Week 9-12 reduction to 0.5mg Tac/ 50mg CsA. Week 12 LFTs. Week 13-16 reduction to 0mg. Week 16 liver biopsy \& LFTs. Weekly LFTs performed Week 17-20. Monthly LFTs for the next 3 months. LFTs every 3 months for monitoring.

Controlled weaning of immunosuppression

Eligibility Criteria

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

You may qualify if:

  • To be eligible to participate in this study, patients must:
  • Be between 18 and 65 years of age.
  • Be recipients of a hepatic allograft.
  • Be less than 3 months post-transplant and be experiencing rejection, or be a minimum of 3 months post-transplant with or without presently experiencing rejection.
  • Be healthy live liver donors

You may not qualify if:

  • Patients with the following conditions may not participate in the study:
  • Patients under the age of 18 and over the age of 65.
  • Patients who are positive for Human Immunodeficiency Virus (HIV),
  • Patients who have detectable levels of HCV RNA, and HBV DNA, at the time of enrollment.
  • Patients who have a combined transplant and/or have been re-transplanted.
  • Patients taking immunosuppression for other diseases besides their liver transplant.
  • Patients unable to give written informed consent in accordance with research ethics board guidelines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

  • Chruscinski A, Rojas-Luengas V, Moshkelgosha S, Issachar A, Luo J, Yowanto H, Lilly L, Smith R, Renner E, Zhang J, Epstein M, Grant D, McEvoy CM, Konvalinka A, Humar A, Adeyi O, Fischer S, Volmer FH, Taubert R, Jaeckel E, Juvet S, Selzner N, Levy GA. Evaluation of a gene expression biomarker to identify operationally tolerant liver transplant recipients: the LITMUS trial. Clin Exp Immunol. 2022 Jan 28;207(1):123-139. doi: 10.1093/cei/uxab011.

    PMID: 35020854DERIVED

Study Officials

  • Gary Levy, M.D.

    University Health Network, University of Toronto

    PRINCIPAL INVESTIGATOR

  • Leslie Lilly, M.D.

    University Health Network, Toronto

    STUDY CHAIR

  • Nazia Selzner, M.D. PhD.

    University Health Network, Toronto

    STUDY CHAIR

  • Meaghan MacArthur, M.Ed

    University Health Network, Toronto

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator, Professor, O. Ont. MD. FRCP AGAF

Study Record Dates

First Submitted

September 2, 2015

First Posted

September 4, 2015

Study Start

April 1, 2015

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

September 30, 2021

Record last verified: 2021-09

Locations

CA(1)