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Study of Tolerant Kidney Transplant Recipients (FACTOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01338779
Recruitment Status : Completed
First Posted : April 20, 2011
Last Update Posted : September 30, 2016
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
The purpose of this multi-center (observational) registry study is to establish a database of clinical and laboratory information that may help to identify any unique characteristics of tolerant participants that differ from participants who reject their kidney after discontinuing immunosuppressive drugs.

Condition or disease
Transplant Rejection Kidney Transplantation Renal Transplantation Renal Transplant Transplant Tolerance

Detailed Description:

Following kidney (renal) transplantation, one possible complication is rejection of the new kidney. This occurs as a results of the body's immune system attacking (or rejecting) the newly transplanted kidney. After transplant, medicines known as "immunosuppressive" or "anti-rejection" drugs are given to transplant recipients to help prevent rejection of the transplanted kidney. If a transplant recipient stops taking these medicines, they almost always reject their transplanted kidney. However, in some exceptionally rare instances, transplant recipients who stop taking these drugs do not reject their kidney, and the kidney keeps working. The recipients are said at that point to "tolerate" the transplanted kidney, and this condition is referred to as "tolerance".

In this study, participants will be asked to provide consent for the collection of extensive demographic and clinical information; medical histories; and blood and urine samples. Blood and urine samples collected will be used to perform specific assays to help define mechanisms of tolerance.

Originally the study included 11 groups as listed; however, at present only groups 1,4, and 8 remain active. Whereas the initial study duration was 6 years, this was extended to 11 years in order to follow over more extended time a B cell signature identified for tolerant kidney subjects and how this signature may change. (Refer to publications section: Newell, Kirk et al, J Clin Invest. 2010).

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Study Type : Observational
Actual Enrollment : 197 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification and Mechanistic Investigations of Tolerant Transplant Recipients
Study Start Date : May 2004
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Group 1 - kidney tolerant
Renal allograft recipients showing functional tolerance (normal and stable renal function) after discontinuation of immunosuppressive medications for at least 1 year (or based on the investigator's discretion).
Group 2 - acceptor
Enrollment for group 2 was closed. Renal transplant recipients with functioning allografts (not on dialysis) who had not received immunosuppressive medications for at least 1 year (or at investigator's discretion) but who had moderately impaired or gradually deteriorating renal function, defined as creatinine clearance (CrCl) < 40 mL/min and/or creatinine > 50% above baseline value, and thus did not qualify for group 1.
Group 3 - kidney graft loss
Enrollment for group 3 is closed. These were renal transplant recipients who had subsequently rejected and lost function of their transplanted kidney.
Group 4 - kidney monotherapy
Renal transplant recipients showing stable and normal renal function after receiving only prednisone 10 mg/day for at least 1 year (or based on the investigator's discretion).
Group 5 - kidney standard immunotherapy
Enrollment for group 5 is closed. Stable renal transplant recipients currently on standard immunosuppression.
Group 6 - kidney chronic rejector
Enrollment for group 6 is closed. Chronic allograft nephropathy group.
Group 7 - kidney identical twin
Enrollment for group 7 is closed.
Group 8 - living kidney donors
Corresponding to recipients in group 1 or 4.
Group 9 - healthy controls
Enrollment for group 9 is closed.
Group 10 - liver tolerant
Enrollment for group 10 is closed. Liver allograft recipients with functional tolerance (stable and normal liver function) after cessation of immunosuppressive medications for at least three years (or at investigator's discretion).
Group 11 - liver standard immunotherapy
Enrollment for group 11 is closed. Subjects with a liver transplant who never had an attempt made to discontinue gradually their immunosuppression and who are currently taking standard immunosuppressive medications and have stable and normal liver allograft function after at least 1 year of receiving these drugs.

Primary Outcome Measures :
  1. To identify individuals who have received a kidney transplant and who have achieved a state of immune tolerance to graft [ Time Frame: 0 to 11 years ]
  2. To create an electronic registry of data on the tolerant and comparison groups that will serve as the basis for statistical analyses [ Time Frame: 0 to 11 years ]
  3. To use data from the registry to perform classical tests of hypotheses regarding the establishment of immune tolerance [ Time Frame: 0 to 11 years ]
  4. To use data from the registry to create and assess predictive statistical models to model such variables as clinical features, duration of tolerant state, and time to onset of immune sensitization [ Time Frame: 0 to 11 years ]

Biospecimen Retention:   Samples With DNA
blood, urine and tissue samples

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • Primary Care Clinics
  • Major Kidney (Renal) Transplant Programs

Inclusion Criteria:

  • Must be a renal transplant recipient or living donor
  • Meet the criteria for inclusion in one of the study enrollment groups
  • Provide informed consent

Exclusion Criteria:

  • AIDS [includes all HIV-infected persons who have less than 200 cells/mm(3) CD4+ T-lymphocytes/microL, or a CD4+ T-lymphocyte/micro liter or a CD4+ T-lymphocyte percent of total lymphocytes less than 14, or who have been diagnosed with an AIDS-defining condition as defined by the Centers for Disease Control and Prevention (CDC)
  • Current malignancy requiring recent surgery, ongoing chemotherapy or radiation
  • Acute systemic infections within 30 days prior to enrollment
  • Pregnancy
  • Transplant of another organ

Note: Patients meeting any of the exclusion criteria, if identified to have been clinically tolerant prior to the occurrence of the excluding condition, will be enrolled and demographic data collected for the registry; however, the decision as to whether or not to collect blood, urine, and tissue samples will be deferred until the participant's condition improves and the clinically tolerant state persists.

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 identifier (NCT number): NCT01338779

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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
NIH Clinical Center
Bethesda, Maryland, United States, 20814
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98104
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
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Study Chair: Kenneth Newell, MD, PhD Emory University

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the site
Identifier: Study ID: FACTOR/ITN507ST
FACTOR/ITN507ST is the Study Identifier in the ITN TrialShare Clinical Trials Research Portal.
Original articles w/data and reports; abstracts et al.  This link exits the site
Identifier: Study ID: FACTOR/ITN507ST
FACTOR/ITN507ST is the Study Identifier in the ITN TrialShare Clinical Trials Research Portal.

Publications of Results:

Other Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT01338779     History of Changes
Obsolete Identifiers: NCT00083655
Other Study ID Numbers: DAIT ITN507ST
First Posted: April 20, 2011    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participant level data access is available to the public in: 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts; and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal.

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
B Cell Signature