A Cohort Study of Operationally Tolerant Allograft Recipients

Stopped early

Conditions studied: Kidney Transplant, Liver Transplant

In brief

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.

Key facts

Study ID

NCT02743793

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

41

Starts

2016-06-30

Expected to finish

2020-03-24

Last updated by the study team

2021-09-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 m\^2.
• 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 may not qualify 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.

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's Memorial Hospital of Chicago — Chicago, Illinois, United States
• University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburg of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.