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Summary

at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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)

Keywords

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

Eligibility

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
  • 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 respectively as:
  • liver function tests (ALT, GGT) for liver transplant recipients,
  • serum creatinine for kidney transplant recipients,
  • below the upper limit of normal (ULN) as defined by ranges from Harrison's Principles of Internal Medicine, 18th edition.
  • 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.

  • and 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.

Locations

  • 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
  • Emory University School of Medicine accepting new patients
    Atlanta, Georgia, 30324, United States
  • Children's Hospital of Pittsburg of UPMC accepting new patients
    Pittsburgh, Pennsylvania, 15224, United States
  • University of Pennsylvania Medical Center accepting new patients
    Philadelphia, Pennsylvania, 19104, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Links
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
ITN ALLTOL Study website
ID
NCT02743793
Lead Scientist
Sandy Feng
Study Type
Observational
Last Updated
September 13, 2017
I’m interested in this study!