Transplant Surgery »  Research »  Clinical Research »  Clinical Trials »  ALLTOL

A Cohort Study of Operationally Tolerant Allograft Recipients

Official Title:

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

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
N/A Observational N/A and older National Institute of Allergy and Infectious Diseases (NIAID) DAIT ITN063ST
NCT02743793
Enrolling patients

Study Design:


Principal Investigator

Professor of Surgery
Division of Transplant Surgery
Director, Abdominal Transplant Fellowship Program

Clinical Research Coordinator

UCSF Medical Center at Parnassus
(415) 476-2574 Phone

Trial 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.

Eligibility

Inclusion Criteria:
  • 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.
Exclusion Criteria:
  • 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.

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 1/26/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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