Immune Monitoring and Assay Development in Organ Transplant Recipients

Conditions

• Organ Transplantation
• Transplantation Immunology

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Accepted

Study Details

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

Key Dates

First listed

Jan 25, 2011

Start date

Nov 30, 2007

Status verified

Sep 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

5,000 participants (estimated)

Arms

• Arm: Immune complications
  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.
• Arm: Stable Transplant Recipient
  Patients who demonstrate immune stability characterized by stable graft function without evident complication. These patients serve as comparators for Group 1
• Arm: Pre-Transplant Longitudinal
  Patients who are candidates for kidney, pancreas, liver or lung transplant will be enrolled and followed longitudinally.
• Arm: Organ Donors
  Donors for individuals meeting the criteria for Cohorts 1-3
• Arm: Disease state
  Individuals with liver, renal or pulmonary diseases that may lead to the development or organ failure.
• Arm: Normal Volunteers

Primary Outcome Measure

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 [ Time Frame: Ongoing ]

Central Contacts

• Shine Thomas, CRC
  404-712-2004
  [email protected]

Locations (2)

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