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A Cohort Study of Operationally Tolerant Allograft Recipients (ALLTOL)

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ClinicalTrials.gov Identifier: NCT02743793
Recruitment Status : Terminated (COVID-19 pandemic and potential risks to study participants and study staff.)
First Posted : April 19, 2016
Last Update Posted : April 13, 2020
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
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study of Operationally Tolerant Allograft Recipients (ITN063ST)
Actual Study Start Date : June 30, 2016
Actual Primary Completion Date : March 24, 2020
Actual Study Completion Date : March 24, 2020
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;
  • No evidence of allograft rejection in the 52 weeks prior to the screening visit (Day 0), based on the participant's medical history; and

  • Normal and stable allograft function at screening visit defined as-

    • For liver transplant recipients: Liver function tests (ALT, GGT) both less than or equal to the upper limit of normal (ULN)
    • For kidney transplant recipients: Serum creatinine value corresponds to an estimated glomerular filtration rate (GFR) > 45 ml/min/1.73 m^2.
 Procedure: Blood Draw
Other Names:
  • Phlebotomy
  • Venesection
  • Venipuncture


Outcome Measures
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Primary Outcome Measures :
  1. Time to Loss of Operational Tolerance [ Time Frame: Day 0 to Year 5 ]

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

    • Absence of rejection (biopsy-proven or clinical rejection), as determined by medical history;
    • Maintenance off immunosuppressive medication, except for short courses of steroids for non-allograft related conditions (i.e., asthma); and

    • Normal and stable allograft function:

      • For liver transplant recipients-Liver function tests (ALT, GGT) that have not increased more than 50% above the participant's baseline values; and
      • For kidney transplant recipients- Serum creatinine values that have not increased more than 25% above the participant's baseline values.


Secondary Outcome Measures :
  1. Time to Development of Anti-Human Leukocyte Antigen (HLA) Antibody or Donor Specific Antibodies (DSA) [ Time Frame: Day 0 to Year 5 ]

    Time to development of either:

    1. de novo HLA antibodies (anti-HLA Ab) post-transplant. Alloantibody is defined as an antibody produced following the introduction of an alloantigen into the system of an individual lacking that particular antigen; OR
    2. Donor Specific Antibodies (DSA), a newly developed alloantibody that is against the donor organ.

    Alloantibodies are important mediators of acute and chronic rejection.


  2. Time to First Episode of Biopsy-Proven or Clinical Acute Rejection, Steroid Resistant Rejection and/or Chronic Rejection [ Time Frame: Day 0 to Year 5 ]
    Time to first episode of acute rejection, steroid resistant rejection and/or chronic rejection.

  3. Time to Graft Loss [ Time Frame: Day 0 to Year 5 ]
    Time to graft loss, not including participant death with functioning graft.


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, 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.
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
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30324
United States, Illinois
Ann & Robert H. Lurie Children's Memorial Hospital of Chicago
Chicago, Illinois, United States, 60611
United States, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburg of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
Investigators
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Study Chair: Sindhu Chandran, M.D. Immune Tolerance Network (ITN)
More Information
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Additional Information:

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02743793    
Other Study ID Numbers: DAIT ITN063ST
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
single organ liver or kidney allograft
operationally tolerant allograft recipients
longitudinal follow-up