Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Tolerance Post Liver Transplantation

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

December 15, 2015

Primary Completion Date

February 10, 2020

Study Completion Date

July 8, 2022

Conditions
Liver TransplantLiver Transplantation
Interventions
BIOLOGICAL

Immunosuppression withdrawal

"Participants will initiate calcineurin inhibitor (CNI) withdrawal after at least 3 weeks of stable liver function, as documented by liver function tests (direct bilirubin, alanine aminotransferase and gamma-glutamyl transferase) separated by at least 1 week in the 3 week period prior to withdrawal.~CNI withdrawal will occur in eight 3 week intervals with each subsequent reduction based on liver function tests over the prior 3 week interval.~Participants on CNI and prednisone will undergo withdrawal from the two therapies concurrently.~If participants are weaned off the CNI successfully, they will initiate non-CNI withdrawal. The non-CNI withdrawal includes two dose reductions of approximately 50% over a 6 week period each, after which the drug will be discontinued."

Trial Locations (7)

10032

Columbia University Medical Center, New York

15213

University of Pittsburgh Medical Center, Pittsburgh

19104

Hospital of the University of Pennsylvania, Philadelphia

60611

Northwestern University Feinberg School of Medicine, Chicago

75246

Baylor University Medical Center at Dallas, Dallas

94143

University of California, San Francisco Medical Center, San Francisco

02114

Massachusetts General Hospital, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Immune Tolerance Network (ITN)

NETWORK

collaborator

PPD Development, LP

INDUSTRY

collaborator

Rho Federal Systems Division, Inc.

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH