NCT01283295 Immune Monitoring and Assay Development in Organ Transplant Recipients
| NCT ID | NCT01283295 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Organ Transplantation |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2007-11 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2007-11 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * Recipients of or candidates for organ transplantation or organ donors for recipients under evaluation at Emory University or CHOA * Normal volunteers to include 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 Children's 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.
Contact & Investigator
Aneesh K Mehta, MD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT01283295 clinical trial?
This trial is open to participants of all sexes, studying Organ Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01283295 currently recruiting?
Yes, NCT01283295 is actively recruiting participants. Contact the research team at shine.thomas@emoryhealthcare.org for enrollment information.
Where is the NCT01283295 trial being conducted?
This trial is being conducted at Atlanta, United States, Atlanta, United States.
Who is sponsoring the NCT01283295 clinical trial?
NCT01283295 is sponsored by Emory University. The principal investigator is Aneesh K Mehta, MD at Emory University. The trial plans to enroll 5,000 participants.