Immune Tolerance and Alloreactivity in Liver Transplant Recipients on Different Monotherapy Immunosuppressive Agents

Completed

Conditions studied: Liver Transplant Rejection, Immunosuppression

In brief

This study is being done with the purpose of trying to understand if and why transplant recipients may develop tolerance to their transplanted organ. Tolerance means being able to lower or take away immunosuppression (anti-rejection medications) without causing organ rejection.

Key facts

Study ID

NCT01678937

Run by

Northwestern University

People needed

31

Starts

2007-09-01

Expected to finish

2008-09-01

Last updated by the study team

2015-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age ≥18 years
• Orthotopic or Living-Related liver transplant (LT) recipient
• Monotherapy patients: > 6 months with stable graft function on current monotherapy (CNI, MMF, or rapamycin)
• Converting patients: CNI therapy converting to rapamycin or MMF monotherapy and > 6 months of stable graft function.
• >1 years post-LT without an acute rejection episode or chronic rejection
• Normal liver function tests (no recurrent HCV, chronic rejection, autoimmune hepatitis, etc.)
• No history of induction or lymphocyte depletion therapy

You may not qualify if…

• Multi-visceral organ recipients
• Graft dysfunction of any etiology
• Inadequate follow-up or available outcomes
• Unable to understand, sign or ask questions regarding the informed consent process and protocol

Where it is running

• Northwestern Memorial Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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