Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Sur… (NCT00531921) | Clinical Trial Compass
CompletedNot Applicable
Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival
United States313 participantsStarted 2007-09
Plain-language summary
Activity of genes in donor tissues that are involved in inflammation are thought to be involved with early organ dysfunction, increased immune responses in transplant recipients, and organ rejection. The purpose of this study is to determine the relationship between genetic expression in donor and recipient tissue with transplant survival. Participants in this study will have received heart, lung, liver, or kidney transplants.
Who can participate
Age range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for all participants:
* Received single lung, heart, kidney, or liver transplant
* Specimens of donor tissues have been collected
* Parent or guardian willing to provide informed consent, if applicable
Inclusion Criteria for Kidney or Liver Transplant Participants:
* 70 years old or younger
Inclusion Criteria for Heart or Lung Transplant Participants:
* Between 16 and 70 years old
Exclusion Criteria for All Participants:
* Previous solid organ transplant
* Need for combined organ transplant
* HIV or hepatitis C virus infection
* Recipient of an organ from a hepatitis C virus-infected donor
* Clinical evidence of systemic bacterial infection in the recipient at the time of transplantation
* Living donor transplant recipient of either a kidney, liver, or lung
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Association between proinflammatory mRNA expression in donor samples and subsequent development of early organ dysfunction in the immediate period following transplantation
Timeframe: Within first 7 days after transplant
2
Association of mRNA expression of proinflammatory mediatros in the transplanted organ in the immediate pre and post-reperfusion period with subsequent incidence of acute rejection and expression of genes involved in cell mediated immunity
Timeframe: 12 months after transplant
Trial details
NCT IDNCT00531921
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)