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
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 Type :||Observational|
|Actual Enrollment :||41 participants|
|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|
Operationally Tolerant Kidney or Liver Allograft Recipients
Operational tolerance at baseline is defined as:
Procedure: Blood Draw
- 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.
- 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:
- 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
- Donor Specific Antibodies (DSA), a newly developed alloantibody that is against the donor organ.
Alloantibodies are important mediators of acute and chronic rejection.
- 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.
- 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
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
|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|
|Study Chair:||Sindhu Chandran, M.D.||Immune Tolerance Network (ITN)|