Immune Monitoring and Assay Development in Organ Transplant Recipients (IMP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Aneesh K. Mehta, Emory University
ClinicalTrials.gov Identifier:
NCT01283295
First received: January 24, 2011
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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


Condition
Organ Transplant
Immunology

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immune Monitoring and Assay Development in Organ Transplant Recipients

Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

PBMCs, serum, urine, kidney and liver biopsy samples, broncheolar lavage fluid


Estimated Enrollment: 5000
Study Start Date: November 2007
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
Stable Transplant Recipient
Patients who demonstrate immune stability characterized by stable graft function without evident complication. These patients serve as comparators for Group 1
Pre-Transplant Longitudinal
Patients who are candidates for kidney, pancreas, liver or lung transplant will be enrolled and followed longitudinally.
Organ Donors
Donors for individuals meeting the criteria for Cohorts 1-3
Disease state
Individuals with liver, renal or pulmonary diseases that may lead to the development or organ failure.
Normal Volunteers

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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)

Criteria

Inclusion Criteria:

  • recipients of or candidates for organ transplantation or organ donors for recipients under evaluation at Emory University or CHOA
  • normal volunteers, including individuals without any known end-stage organ disease who are not on any immunosuppressive medication, and individuals with conditions requiring immunosuppression (i.e. dermatological diseases) that do not require transplant therapies
  • ability to understand the purposes and risks of the study and willingly give written informed consent, or in the case of minors, ability to give minor assent (children older than 5 years of age), in conjunction with written guardian consent

Exclusion Criteria:

  • patients who fail to meet the criteria for transplantation or post-transplant follow-up by Emory or Childrens Healthcare of Atlanta physicians
  • Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating. Specific conditions include but are not limited to: anemia prohibitive of phlebotomy, coagulopathy or technical considerations that would prevent acquisition of sufficient tissue on biopsy for clinical use, or medical urgency preventing timely administration of the consenting process.
  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: NCT01283295

Contacts
Contact: Shine Thomas, CRC 404-712-2004 shine.thomas@emoryhealthcare.org
Contact: Beth Begley, RN 404-712-7168 beth.begley@emoryhealthcare.org

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Tauri Harden, CRC         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Aneesh K Mehta, MD Emory University
  More Information

No publications provided

Responsible Party: Aneesh K. Mehta, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01283295     History of Changes
Other Study ID Numbers: IRB00006248, IMP
Study First Received: January 24, 2011
Last Updated: June 9, 2014
Health Authority: United States: Emory University Institutional Review Board

ClinicalTrials.gov processed this record on July 24, 2014