Study of Tolerant Kidney Transplant Recipients
Completed
Conditions studied: Transplant Rejection, Kidney Transplantation, Renal Transplantation, Renal Transplant, Transplant Tolerance
In brief
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.
Key facts
- Study ID
- NCT01338779
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 197
- Starts
- 2004-05-01
- Expected to finish
- 2015-08-01
- Last updated by the study team
- 2016-09-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Must be a renal transplant recipient or living donor
- Meet the criteria for inclusion in one of the study enrollment groups
- Provide informed consent
You may not qualify if…
- 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.
Where it is running
- Emory University — Atlanta, Georgia, United States
- NIH Clinical Center — Bethesda, Maryland, United States
- Swedish Medical Center — Seattle, Washington, United States
- University of Wisconsin — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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