NCT01283295|Recruiting
Immune Monitoring and Assay Development in Organ Transplant Recipients
IMP
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IMP
Sponsor study identifier
observational
5,000
1 country
2
Study Start
November 2007
Actual (reported)Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The purpose of this study to develop a well-characterized library of blood, biopsy tissue, and urine samples from transplant patients. Subjects without transplants will also be enrolled for comparison. Samples will be used to study the characteristics of patients undergoing transplantation that influence their response to transplant therapies and their reactions to drugs used in transplantation. This knowledge is important as it helps physicians design new drugs and tailor transplant therapies to the individual thereby reducing the side effects. In this study, people will be asked to donate blood, biopsy tissue and urine. Donation of these samples will not influence patients' treatments. These samples will be tested using a variety of biological tests to better understand how immunosuppressive drugs change the various components of the immune system. The tests will be for research only; no changes in an individual's treatment will be based on the results of tests performed in this study. If there is extra sample, the sample will be stored for use in other testing at a later date. The ultimate goal is find the right combination of medications for each individual patient while keeping their new organ working well. This study is a first step in that direction by perfecting tests used to characterize a patient's immune system
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2007
Actual (reported)January 24, 2011
Actual (reported)January 25, 2011
Actual (reported)December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
To generate a bank of well-characterized biological samples from human subjects prior to or following organ transplantation for the purpose of subsequent evaluation using new and existing immunological assays
Ongoing
Transplant recipients who develop a clinically recognized complication with potential immune etiology or ramifications. Examples include opportunistic infection, rejection, malignancy, alloantibody formation or immunosuppressive drug toxicity.
Patients who demonstrate immune stability characterized by stable graft function without evident complication. These patients serve as comparators for Group 1
Patients who are candidates for kidney, pancreas, liver or lung transplant will be enrolled and followed longitudinally.
Donors for individuals meeting the criteria for Cohorts 1-3
Individuals with liver, renal or pulmonary diseases that may lead to the development or organ failure.
Pediatric or adult organ transplant recipients, candidates for organ transplant, donors and normal volunteers of Emory University Hospital, the Emory Transplant Center or Children's Healthcare of Atlanta (CHOA)
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Emory University
Atlanta, Georgia, 30322, United States
PBMCs, serum, urine, kidney and liver biopsy samples, broncheolar lavage fluid
Aneesh K Mehta, MD
Emory University
First Submitted
January 24, 2011
First Posted
January 25, 2011
Study Start
November 2007
Actual (reported)Primary Completion
December 2027
EstimatedGastrointestinal Tolerability of MMF vs EC-MPS in Maintenance Transplant Patients Treated With Calcineurin Inhibitors
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 10, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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