Study of Tolerant Kidney Transplant Recipients (FACTOR)

September 29, 2016 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Identification and Mechanistic Investigations of Tolerant Transplant Recipients

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.

Study Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Actual)

197

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • NIH Clinical Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  • Primary Care Clinics
  • Major Kidney (Renal) Transplant Programs

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
0 to 11 years
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
0 to 11 years
To use data from the registry to perform classical tests of hypotheses regarding the establishment of immune tolerance
Time Frame: 0 to 11 years
0 to 11 years
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
0 to 11 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Immune Tolerance Network (ITN)

Investigators

  • Study Chair: Kenneth Newell, MD, PhD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

April 18, 2011

First Submitted That Met QC Criteria

April 18, 2011

First Posted (Estimate)

April 20, 2011

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DAIT ITN507ST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: ImmPort Study ID: SDY546
  2. Study Protocol
    Information identifier: ImmPort Study ID: SDY546
  3. Study summary,-design, demographics,mechanistic assays,-study files et al.
    Information identifier: ImmPort Study ID: SDY546
  4. Individual Participant Data Set
    Information identifier: Study ID: FACTOR/ITN507ST
    Information comments: FACTOR/ITN507ST is the Study Identifier in the ITN TrialShare Clinical Trials Research Portal.
  5. Original articles w/data and reports; abstracts et al.
    Information identifier: Study ID: FACTOR/ITN507ST
    Information comments: FACTOR/ITN507ST is the Study Identifier in the ITN TrialShare Clinical Trials Research Portal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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