A Cohort Study of Operationally Tolerant Allograft Recipients



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:Any
Updated:5/27/2018
Start Date:June 2016
End Date:January 2021

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A Prospective Cohort Study of Operationally Tolerant Allograft Recipients (ITN063ST)

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.


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.
We found this trial at
5
sites
Pittsburgh, Pennsylvania
Principal Investigator: George Mazariegos, MD
Phone: 412-692-7673
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Principal Investigator: Kenneth Newell, MD, PhD
Phone: 404-712-4117
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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Chicago, Illinois 60611
Principal Investigator: Estella Alonso, MD
Phone: 312-227-4559
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Chicago, IL
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Philadelphia, Pennsylvania
Principal Investigator: Abraham Shaked, MD, PhD
Phone: 215-614-0528
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Philadelphia, PA
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San Francisco, California 94143
Principal Investigator: Sandy Feng, MD, PhD
Phone: 415-476-2574
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San Francisco, CA
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