Clinical trial Recruiting at 2 sites Observational

Developing a library of samples from organ transplant patients

Official title: Immune Monitoring and Assay Development in Organ Transplant Recipients

Run by Emory University · NCT01283295 · Data updated 2026-11-12

This study is collecting blood, tissue, and urine samples from organ transplant patients and healthy volunteers to see how their bodies respond to transplant treatments and medications.

Quick facts

Study typeObservational
SexAll
Enrollment5000 (estimated)
SponsorEmory University
Academic / other
Locations2 sites (Atlanta, Georgia and 1 other locations)
StatusRecruiting
StartedNovember 2007
Main results expectedDecember 2027
Study endsDecember 2028
Registry record updatedSeptember 10, 2026
Trial IDNCT01283295 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include organ transplant recipients, candidates for transplantation, and healthy volunteers without end-stage organ disease.

Probably not a fit

Patients who do not meet the criteria for transplantation or have conditions that pose undue risk may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to create a well-characterized library of blood, biopsy tissue, and urine samples from organ transplant recipients, as well as from healthy volunteers for comparison. The samples will be analyzed to understand how patients respond to transplant therapies and the immunosuppressive drugs used in transplantation. By studying these biological samples, researchers hope to tailor transplant therapies to individual patients, potentially reducing side effects. Participation involves donating samples, which will not affect the participants' treatment plans.

Why it matters

Potential benefit: If successful, this study could lead to more personalized transplant therapies that minimize side effects for patients.

How similar studies have gone: Other studies have shown success in using biological samples to improve transplant therapies, indicating that this approach is promising.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Children's Healthcare of Atlanta
    Atlanta, Georgia, United States
    Recruiting
  • Emory University
    Atlanta, Georgia, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.