Biomarkers in Transplant Recipients
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ClinicalTrials.gov Identifier: NCT01163578 |
Recruitment Status :
Recruiting
First Posted : July 15, 2010
Last Update Posted : April 2, 2020
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Sponsor:
University of Pittsburgh
Information provided by (Responsible Party):
Rakesh Sindhi, University of Pittsburgh
Tracking Information | |||||
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First Submitted Date | June 29, 2010 | ||||
First Posted Date | July 15, 2010 | ||||
Last Update Posted Date | April 2, 2020 | ||||
Study Start Date | March 2005 | ||||
Estimated Primary Completion Date | March 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Rejection [ Time Frame: 90 day post transplantation (clinical severity) ] Biopsy-proven acute cellular rejection
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Original Primary Outcome Measures |
Rejection or Graft vs. Host Disease [ Time Frame: 90 day post transplantation (clinical severity) ] | ||||
Change History | |||||
Current Secondary Outcome Measures |
Thresholds of immunosuppression [ Time Frame: Yearly post transplantation ] Blood levels and doses of the various immunosuppressants at one year. For example, Tacrolimus is measured as nanograms/ml in whole blood, Mycophenolate mofetil is measured in doses of mg/day, or as blood levels in micrograms/ml, steroids doses are measured in mg/day, Sirolimus is measured in doses of mg/day, or as blood levels in nanograms/ml in whole blood.
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Biomarkers in Transplant Recipients | ||||
Official Title | Study of Biomarkers in Solid Organ and Bone Marrow Transplant Recipients to Better Treat Rejection | ||||
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. | ||||
Detailed Description | All transplant recipients receive periodic monitoring of drug levels and laboratory tests to assess adequacy of immunosuppression and allograft function. These are performed when the recipient is admitted to the hospital after transplantation or for a complication such as acute rejection or toxicity, or when the recipient is an outpatient.
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Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description: blood, saliva, intestinal and liver biospy samples, urine, stool
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Sampling Method | Non-Probability Sample | ||||
Study Population | Individuals who are listed and or recipients of solid organ or bone marrow transplantation. | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
1200 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | March 2025 | ||||
Estimated Primary Completion Date | March 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT01163578 | ||||
Other Study ID Numbers | IRB0405628 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement | Not Provided | ||||
Responsible Party | Rakesh Sindhi, University of Pittsburgh | ||||
Study Sponsor | University of Pittsburgh | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | University of Pittsburgh | ||||
Verification Date | April 2020 |