100
Participants
Start Date
December 15, 2015
Primary Completion Date
February 10, 2020
Study Completion Date
July 8, 2022
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."
Columbia University Medical Center, New York
University of Pittsburgh Medical Center, Pittsburgh
Hospital of the University of Pennsylvania, Philadelphia
Northwestern University Feinberg School of Medicine, Chicago
Baylor University Medical Center at Dallas, Dallas
University of California, San Francisco Medical Center, San Francisco
Massachusetts General Hospital, Boston
Collaborators (1)
Immune Tolerance Network (ITN)
NETWORK
PPD Development, LP
INDUSTRY
Rho Federal Systems Division, Inc.
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH