Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival

Completed

• Conditions: Heart Transplantation; Liver Transplantation; Lung Transplantation; Kidney Transplantation

• Registration Number: NCT00531921
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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.

Detailed Description

Inflammation and injuries to transplanted organs during the immediate post-operative period may be linked to early organ dysfunction and higher rates of transplant rejection in the recipient. Currently, mRNA expression of proinflammatory genes in donor tissues is thought to be a risk factor for early organ transplant dysfunction, increased expression of the recipients cell-mediated immunity genes, and organ rejection. The purpose of this study is to test the association between proinflammatory mRNA expression in donor samples and subsequent development of early organ dysfunction in kidney, lung, and liver transplant recipients. This study will also test the effects of proinflammatory mediators expressed in the transplanted organ pre- and post-reperfusion on organ rejection and genes expressed in cell mediated immune responses. This will be achieved by identifying the proinflammatory immune responses and their mechanisms.

This study will consist of up to 11 study visits over a period of 2 years. The baseline visit will occur 24 hours prior to organ transplantation. Follow-up visits will occur daily for Days 1 to 3 (for lung transplant recipients only) and on Day 7, Week 6, and Months 3, 6, 9, 12, 18, and 24 post-transplant. At the baseline visit, a physical exam, medical history, demographics, vital signs measurements, blood collection, and collection of donor tissue sample will occur. For most or all other study visits, medication and adverse events tracking and blood collection will occur. Depending on the transplant type, participants will undergo the following procedures:

* Heart: Participants will undergo a heart biopsy that is part of standard clinical care following a heart transplant. An echocardiogram and an electrocardiogram will occur at most visits.

* Kidney: Renal biopsies will be performed 1 hour after reperfusion at the time of surgery. Urine collection will occur at most visits.

* Liver: Liver biopsies will be performed at the time of procurement and within 1 hour of reperfusion.

* Lung: Participants will undergo bronchoalveolar lavage that is part of standard clinical care following a lung transplant. A chest x-ray, an arterial blood gas test, a pulmonary function test, and 6-minute walking test will occur at some visits.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-18
• Study First Submitted QC: 2007-09-18
• Study First Posted: 2007-09-19
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-03
• Last Update Posted: 2013-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	12 months after transplant
Association between proinflammatory mRNA expression in donor samples and subsequent development of early organ dysfunction in the immediate period following transplantation	Within first 7 days after transplant

Trial Locations

Locations (5)

University of Pennsylvania (heart, kidney, liver, lung); 🇺🇸 Philadelphia, Pennsylvania, United States

Columbia University (lung and liver); 🇺🇸 New York, New York, United States

Cornell University Medical College (kidney); 🇺🇸 Ithaca, New York, United States

Northwestern Memorial Hospital (kidney and liver); 🇺🇸 Chicago, Illinois, United States

University of Wisconsin (heart and lung); 🇺🇸 Madison, Wisconsin, United States