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Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival
This study is currently recruiting participants.
Verified by National Institute of Allergy and Infectious Diseases (NIAID), September 2008
Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00531921
  Purpose

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.


Condition
Heart Transplantation
Kidney Transplantation
Liver Transplantation
Lung Transplantation

MedlinePlus related topics: Heart Transplantation Kidney Transplantation Liver Transplantation Lung Transplantation
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Correlation of Donor Proinflammatory mRNA Profiles With Early Outcomes of Thoracic and Abdominal Transplantation

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Association between proinflammatory mRNA expression in donor samples and subsequent development of early organ dysfunction in the immediate period following transplantation [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Blood and tissue samples to evaluate the heart, kidney, liver, and lung


Estimated Enrollment: 450
Study Start Date: September 2007
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Kidney transplant patients from six specific sites
2
Liver transplant patients from six specific sites
3
Heart transplant patients from six specific sites
4
Lung transplant patients from six specific sites

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.
  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Transplant patients evaluated for the association between proinflammatory mRNA expression from donor samples and subsequent development of early organ dysfunction

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531921

Contacts
Contact: Tina Sledge, RN, BSN 301-496-3017 sledget@niaid.nih.gov

Locations
United States, Illinois
Northwestern Memorial Hospital (kidney) Recruiting
Chicago, Illinois, United States, 60611
Contact: Jane Charette         jane-charette@northwestern.edu    
Principal Investigator: John Friedewald, MD            
Northwestern Memorial Hospital (liver) Recruiting
Chicago, Illinois, United States, 60611
Contact: Jane Charette         jane-charette@northwestern.edu    
Principal Investigator: Mike Abecassis, MD            
United States, New York
Columbia University (lung) Recruiting
New York, New York, United States, 10032
Contact: Steven Kawut, MD         sk2097@columbia.edu    
Principal Investigator: Steven Kawut, MD            
Cornell University Medical College (kidney) Not yet recruiting
Ithaca, New York, United States, 14850
Contact: Maria Trantino         mat2026@med.cornell.edu    
Principal Investigator: Darshana Dadhania, MD            
Columbia University (liver) Recruiting
New York, New York, United States, 10032
Contact: Jonathan Kim         jk2805@columbia.edu    
Principal Investigator: Jean Emond, MD            
United States, Ohio
Cleveland Clinic Foundation (heart) Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Barbara Gus         gusb@ccf.org    
Principal Investigator: Randall Starling, MD            
United States, Pennsylvania
University of Pennsylvania (heart) Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary Kaminski, MD         mary.kaminski@uphs.upenn.edu    
Principal Investigator: Thomas Cappola, MD            
University of Pennsylvania (lung) Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary Kaminski         mary.kaminski@uphs.upenn.edu    
Principal Investigator: Jason Christie, MD            
University of Pennsylvania (kidney) Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary Kaminski         mary.kaminski@uphs.upenn.edu    
Principal Investigator: Alden Doyle, MD            
University of Pennsylvania (liver) Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary Kaminski         mary.kaminski@uphs.upenn.edu    
Principal Investigator: Kim Oltoff, MD            
United States, Wisconsin
University of Wisconsin (heart) Recruiting
Madison, Wisconsin, United States, 53706
Contact: Talley Mitchell         mmitchell@clinicaltrials.wisc.edu    
Principal Investigator: Nancy Sweitzer, MD            
University of Wisconsin (lung) Recruiting
Madison, Wisconsin, United States, 53706
Contact: Holly Thomas         HThomas@uwhealth.org    
Principal Investigator: Keith Meyer, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Abraham Shaked, MD, PhD University of Pennsylvania Medical Center
  More Information

Click here for the Clinical Trials in Organ Transplantation (CTOT) public Web site  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: DAIT/NIAID ( Associate Director, Clinical Research Program )
Study ID Numbers: DAIT CTOT-03
Study First Received: September 18, 2007
Last Updated: January 14, 2009
ClinicalTrials.gov Identifier: NCT00531921  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Heart Diseases
Kidney Diseases
Liver Diseases
Liver Failure
Lung Diseases
Transplant
Transplantation, Homologous
Rejection
Kidney Failure

Study placed in the following topic categories:
Liver Failure
Liver Diseases
Heart Diseases
Lung Diseases
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 16, 2009