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A Cohort Study of Operationally Tolerant Allograft Recipients (ALLTOL)

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ClinicalTrials.gov Identifier: NCT02743793
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : May 25, 2018
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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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.

Condition or disease Intervention/treatment
Kidney Transplant Liver Transplant Procedure: Blood Draw

Study Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study of Operationally Tolerant Allograft Recipients (ITN063ST)
Study Start Date : June 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Operationally Tolerant Kidney or Liver Allograft Recipients

Operational tolerance at baseline is defined as:

  • an 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 (Day 0), based on the participant's medical history.
 Procedure: Blood Draw
Other Names:
  • Phlebotomy
  • Venesection
  • Venipuncture


Outcome Measures
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Primary Outcome Measures :
  1. Kaplan-Meier Analysis of Time-to-Occurrence: Percentage of Participants with Loss of Operational Tolerance by Visit [ Time Frame: Day 0 and years 1,2,3,4, and 5 ]

    Operational tolerance (to their kidney or liver transplant) defined by:

    • Absence of rejection, as determined by medical history;
    • Maintenance off immunosuppressive medication, with the exception of short courses of steroids for nonallograft related conditions; and
    • Normal and stable allograft function, defined respectively as liver function tests (ALT, GGT-for liver transplant recipients) or serum creatinine (for kidney transplant recipients) that have not increased more than 50% above the participant's baseline liver function test or serum creatinine value. The baseline value is the liver function tests or serum creatinine drawn at the screening (Day 0) visit.


Secondary Outcome Measures :
  1. Kaplan-Meier Analysis of Time-to-Occurrence: Percentage of Participants that Develop de novo Anti-Human Leukocyte Antigen (HLA) Antibody or Donor Specific Antibodies (DSA) by Visit [ Time Frame: Day 0 and years 1,2,3,4, and 5 ]
  2. Kaplan-Meier Analysis of Time-to-Occurrence:Percentage of Participants that Develop First Episode of Rejection by Visit [ Time Frame: Day 0 and years 1,2,3,4, and 5 ]
    First Episode of Acute Rejection, Steroid Resistant Rejection and Chronic Rejection

  3. Kaplan-Meier Analysis of Time-to-Occurrence: Percentage of Participants that Experience Graft Loss by Visit [ Time Frame: Day 0 and years 1,2,3,4, and 5 ]
  4. Kaplan-Meier Analysis of Time-to-Occurrence: Percentage of Participant Survival by Visit [ Time Frame: Day 0 and years 1,2,3,4, and 5 ]
    All-cause mortality, liver or kidney transplant recipients.

  5. Changes in Renal Function Over Time in Renal Transplant Recipients by Visit [ Time Frame: Day 0 and years 1,2,3,4, and 5 ]
    Defined as estimated glomerular filtration rate (GFR) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)

  6. Changes in Liver Function Tests (LFTs) Over Time in Liver Transplant Recipients by Visit [ Time Frame: Day 0 and years 1,2,3,4, and 5 ]
    Serum alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT)

  7. Kaplan-Meier Analysis of Time-to-Occurrence: Incidence of Biliary Complications in Liver Transplant Recipients by Visit [ Time Frame: Day 0 and years 1,2,3,4, and 5 ]
    Incidence of medical outcomes associated with long-term immunosuppression such as diabetes, hypertension, hyperlipidemia.

  8. Incidence of Diabetes or Use of Concomitant Medications for Hypertension and/or Hyperlipidemia by Visit [ Time Frame: Day 0 and years 1,2,3,4, and 5 ]

Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Operationally tolerant recipients of liver or kidney allografts
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
    • 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:

    1. liver function tests (ALT, GGT) for liver transplant recipients,

    2. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743793


Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Samvika Mehra    415-476-2574    Samvika.Mehra@ucsf.edu   
Principal Investigator: Sandy Feng, MD, PhD         
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30324
Contact: Rivka Elbein    404-712-4117    rselbei@emory.edu   
Principal Investigator: Kenneth Newell, MD, PhD         
United States, Illinois
Ann & Robert H. Lurie Children's Memorial Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Joy Ito    312-227-4559    jito@luriechildrens.org   
Principal Investigator: Estella Alonso, MD         
United States, Pennsylvania
University of Pennsylvania Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary C Shaw    215-614-0528    mary.shaw@uphs.upenn.edu   
Principal Investigator: Abraham Shaked, MD, PhD         
Children's Hospital of Pittsburg of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Catherine Scott    412-692-7673    catherine.scott3@chp.edu   
Principal Investigator: George Mazariegos, MD         
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
Investigators
Study Chair: Laurence A. Turka, M.D. Massachusetts General Hospital: Transplantation
More Information
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Additional Information:
National Institute of Allergy and Infectious Diseases (NIAID)  This link exits the ClinicalTrials.gov site
Immune Tolerance Network (ITN)  This link exits the ClinicalTrials.gov site
ITN ALLTOL Study website  This link exits the ClinicalTrials.gov site

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02743793     History of Changes
Other Study ID Numbers: DAIT ITN063ST
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
single organ liver or kidney allograft
operationally tolerant allograft recipients
longitudinal follow-up