at San Francisco, California and other locations
study started
estimated completion
Sandy Feng, MD, PhD



Antirejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent their bodies from rejecting the new organ. Some organ transplant recipients can stop taking anti-rejection medicines without rejecting their transplanted organ (this is called 'tolerance'). The purpose of this study will collect samples and data from 'tolerant' liver or kidney transplant recipients in order to find out: The purpose of this study is to collect samples and data in order to find out: - How long liver or kidney transplant recipients can remain tolerant; - What happens in the tolerant recipient's body over time; and - If there are patterns in the body that are linked to tolerance.

Official Title

A Prospective Cohort Study of Operationally Tolerant Allograft Recipients (ITN063ST)


Kidney Transplant Liver Transplant single organ liver or kidney allograft operationally tolerant allograft recipients longitudinal follow-up Blood Draw


You can join if…

  • Recipient of single organ liver or kidney allograft from a living or deceased donor;
  • At screening, operationally tolerant, as defined by:
  • Absence of any immunosuppressive therapy for ≥52 weeks prior to the screening visit, and
  • No evidence of allograft rejection in the 52 weeks prior to the screening visit, based on the allograft recipient's medical history.
  • Normal allograft function, defined as:
  • For liver transplant recipients: Liver function tests (ALT, GGT) both less than or equal to the upper limit of normal (ULN); and,
  • For kidney transplant recipients: Serum creatinine value corresponds to an estimated GFR > 45 ml/min/1.73 m2.

  • Receiving regular follow-up for a kidney or liver transplant by a local physician:

--Participants must be willing to allow the study team to contact and share medical information with this local physician.

  • Ability to sign informed consent.

You CAN'T join if...

  • Current malignancy requiring recent surgery, ongoing chemotherapy, or radiation;
  • Transplant of another organ;
  • Current drug or alcohol dependency;
  • Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial; and
  • Inability to comply with the study visit schedule and required assessments.


  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • Ann & Robert H. Lurie Children's Memorial Hospital of Chicago accepting new patients
    Chicago Illinois 60611 United States

Lead Scientist


accepting new patients
Start Date
Completion Date
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
ITN ALLTOL Study website
Study Type
Last Updated