Clinical trial NCT02743793: A Cohort Study of Operationally Tolerant Allograft Recipients
Official title: A Prospective Cohort Study of Operationally Tolerant Allograft Recipients (ITN063ST)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kidney Transplant
Liver Transplant
Keywords: single organ liver or kidney allograft
operationally tolerant allograft recipients
longitudinal follow-up
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Immune Tolerance Network (ITN)
name: PPD Development, LP
name: Rho Federal Systems Division, Inc.
First posted: 2016-04-19
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Operationally tolerant recipients of liver or kidney allografts

Brief 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.

Detailed description: This is a multi-center, prospective, observational study in which operationally tolerant recipients of liver or kidney allografts will be followed longitudinally, with annual collections of clinical data and biological samples. All participants will be followed for the duration of the study, regardless of changes in their tolerance status.

Participants will be recruited by three main pathways:

1. Tolerant participants from current and past Immune Tolerance Network (ITN) trials, including those who have already completed trial participation and those who are anticipated to complete trial participation,
2. Tolerant participants referred by ITN affiliated investigators, academic and community transplant physicians and directly through outreach to transplant affinity groups such as the National Kidney Foundation (NKF), and
3. Tolerant participants from the general transplant community who are reachable through general contact channels such as the ITN website, word-of-mouth referrals from existing participants, and social media.

Eligibility criteria: 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, 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.

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.

Primary outcomes:
measure: Time to Loss of Operational Tolerance
timeFrame: From operational tolerance to ITN063ST study completion, assessed up to 60 months
Secondary outcomes:
measure: Time to Development of Anti-Human Leukocyte Antigen (HLA) Antibody or Donor Specific Antibodies (DSA)
timeFrame: Day 0 (Study Enrollment) to Study Completion (Up to 3.7 years)
measure: Number of Participants With Biopsy-Proven or Clinical Acute Rejection, Steroid Resistant Rejection and/or Chronic Rejection
timeFrame: Day 0 (Study Enrollment) to Study Completion (Up to 3.7 years)
measure: Number of Participants With Graft Loss, Not Including Death With a Functioning Graft
timeFrame: Day 0 (Study Enrollment) to Study Completion (Up to 3.7 years)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Memorial Hospital of Chicago
state: Illinois
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburg of UPMC
state: Pennsylvania
Study officials:
affiliation: Immune Tolerance Network (ITN)
name: Sindhu Chandran, M.D.
role: STUDY_CHAIR
References: