Study of Tolerant Kidney Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01338779
First received: April 18, 2011
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

Following kidney transplantation, one possible complication is rejection of the new kidney. This occurs because the body's immune system tries to attack (or reject) the newly transplanted kidney. After transplant, medicines known as "immunosuppressive" or "anti-rejection" drugs are given to everyone 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".

The purpose of this 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
Immune System Diseases
Graft Rejection
Kidney Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification and Mechanistic Investigations of Tolerant Transplant Recipients

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • To identify individuals who have received a kidney transplant and who have achieved a state of immune tolerance to graft. [ Time Frame: 0 to 8 years ] [ Designated as safety issue: No ]
  • 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 8 years ] [ Designated as safety issue: No ]
  • To use data from the registry to perform classical tests of hypotheses regarding the establishment of immune tolerance. [ Time Frame: 0 to 8 years ] [ Designated as safety issue: No ]
  • 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 8 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood, urine and tissue samples


Enrollment: 225
Study Start Date: May 2004
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1 - kidney tolerant
Group 2 - acceptor
Enrollment for group 2 was closed
Group 3 - kidney graft loss
Enrollment for group 3 is closed
Group 4 - kidney monotherapy
Group 5 - kidney standard immunotherapy
Enrollment for group 5 is closed
Group 6 - kidney chronic rejector
Enrollment for group 6 is closed
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
Group 11 - liver standard immunotherapy
Enrollment for group 11 is closed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

primary care clinic major kidney transplant programs

Criteria

Inclusion Criteria:

  • Must be a renal transplant recipient or living donor
  • Meet the criteria for inclusion in one of the study 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 Center for Disease Control (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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01338779

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
NIH Clinical Center
Bethesda, Maryland, United States
United States, Washington
Swedish Medical Center
Seattle, Washington, United States
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Immune Tolerance Network (ITN)
Investigators
Study Chair: Kenneth Newell, MD, PhD Emory University
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01338779     History of Changes
Obsolete Identifiers: NCT00083655
Other Study ID Numbers: DAIT ITN507ST
Study First Received: April 18, 2011
Last Updated: June 4, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Tolerance
Renal
Allograft

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014