Biomarkers in Transplant Recipients to Improve Outcomes
Study of Biomarkers in Solid Organ and Bone Marrow Transplant Recipients to Better Treat Rejection
1 other identifier
observational
1,200
1 country
1
Brief Summary
The objective of this study is to evaluate whether certain proteins, expressed in biological tissues can indict a better understanding of the effect of drugs that are used to treat rejection, and of processes leading to rejection and rejection-free outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 29, 2010
CompletedFirst Posted
Study publicly available on registry
July 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
September 9, 2025
September 1, 2025
25 years
June 29, 2010
September 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rejection
Biopsy-proven acute cellular rejection
90 day post transplantation (clinical severity)
Secondary Outcomes (1)
Thresholds of immunosuppression
Yearly post transplantation
Eligibility Criteria
Individuals who are listed and or recipients of solid organ or bone marrow transplantation.
You may qualify if:
- Recipients of abdominal, thoracic and bone marrow allografts that are receiving inpatient and outpatient follow-up with routine laboratory tests at the University of Pittsburgh Medical Center.
- All Ages
- Subject or parents are able to read and understand the informed consent
You may not qualify if:
- Subjects and/or their parents who are unable to read and understand informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Related Publications (2)
Ashokkumar C, Sun Q, Ningappa M, Higgs BW, Mazariegos G, Zeevi A, Sindhi R. Antithymocyte globulin facilitates alloreactive T-cell apoptosis by means of caspase-3: potential implications for monitoring rejection-free outcomes. Transplantation. 2015 Jan;99(1):164-70. doi: 10.1097/TP.0000000000000289.
PMID: 25531894DERIVEDAshokkumar C, Gabriellan A, Ningappa M, Mazariegos G, Sun Q, Sindhi R. Increased monocyte expression of sialoadhesin during acute cellular rejection and other enteritides after intestine transplantation in children. Transplantation. 2012 Mar 15;93(5):561-4. doi: 10.1097/TP.0b013e3182449189.
PMID: 22249367DERIVED
Biospecimen
blood, saliva, intestinal and liver biospy samples, urine, stool
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rakesh Sindhi, MD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Surgery
Study Record Dates
First Submitted
June 29, 2010
First Posted
July 15, 2010
Study Start
March 1, 2005
Primary Completion (Estimated)
March 1, 2030
Study Completion (Estimated)
March 1, 2030
Last Updated
September 9, 2025
Record last verified: 2025-09