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Discovery and Validation of Proteogenomic Biomarker Panels in Liver Transplant Recipients (PROGENI-LI)

This study has been completed.
Sponsor:
Collaborator:
Clinical Trials in Organ Transplantation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01672164
First received: August 16, 2012
Last updated: September 1, 2016
Last verified: September 2016
  Purpose
The main focus of this study is to develop blood and/or urine tests that will help to detect early signs of rejection in people who have had a liver transplant. Researchers will examine blood, urine, and tissue samples and try to identify markers for certain conditions such as rejection, response to therapy, and scarring of the liver. Additionally, researchers would like to identify biomarkers that can detect damage to the native kidneys before blood levels of creatinine rises. By studying gene expression, researchers hope to be able to diagnose these conditions earlier and improve liver survival.

Condition
Liver Transplant Recipients
Liver Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Discovery and Validation of Proteogenomic Biomarker Panels in a Prospective Serial Blood and Urine Monitoring Study of Liver Transplant Recipients - Transplant Proteogenomics

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Acute Rejection [ Time Frame: 3 months after liver transplant ] [ Designated as safety issue: Yes ]
    The primary endpoint is the incidence of biopsy proven AR at 3, 12 and 24 months after LT.

  • Acute Rejection [ Time Frame: 12 months after liver transplant ] [ Designated as safety issue: Yes ]
  • Acute Rejection [ Time Frame: 24 months after liver transplant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Severity of acute rejection [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12): ] [ Designated as safety issue: Yes ]
    Severity (initial grade, steroid-responsive vs. refractory by biopsy) and clinical/biochemical resolution following treatment of AR

  • Recurrent Hepatitis-C Virus (HCV-R) [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ] [ Designated as safety issue: Yes ]
    Incidence, severity (grade, stage), and treatment (requirement for, response rates) of HCV-R

  • Chronic Kidney Disease(CKD) [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ] [ Designated as safety issue: Yes ]
    Incidence, severity (stage, need for renal replacement therapy or kidney transplantation), and response to treatment (CNI reduction/withdrawal ± MPA or mTOR) of CKD

  • Incidence of death, graft loss, and need for liver retransplantation [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ] [ Designated as safety issue: Yes ]
  • Incidence of opportunistic infections, malignancy, and cardiovascular complications [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ] [ Designated as safety issue: Yes ]
  • mRNA expression profiles of peripheral blood (AR, HCV-R, CKD) [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ] [ Designated as safety issue: No ]
  • mRNA expression profiles of liver biopsies (AR, HCV-R) [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ] [ Designated as safety issue: No ]
  • Protein expression profiles of plasma ( AR, HCV-R, CKD) [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ] [ Designated as safety issue: No ]
  • Protein expression profiles of urine (CKD) [ Time Frame: Baseline (Visit 1) to Month 24 (visit 12) ] [ Designated as safety issue: No ]
  • microRNA Profiling Plasma & Cells [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ] [ Designated as safety issue: No ]
  • Multiparameter Flow Cytometry - Viral Pathogens [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ] [ Designated as safety issue: No ]
  • Viral Monitoring - EBV & CMV [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
whole blood, plasma, serum, urine supernatant, urine pellet and tissue

Enrollment: 202
Study Start Date: August 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Liver Transplant Recipients

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Liver Transplant Recipients
Criteria

Inclusion Criteria:

  • Subjects undergoing primary deceased-donor or living donor liver transplantation;
  • Subject must be able to understand and provide informed consent.

Exclusion Criteria:

  • Need for combined organ transplantation;
  • Previous solid organ and/or islet cell transplantation;
  • Infection with HIV;
  • Allergy to iodine;
  • Inability or unwillingness of a participant to comply with study protocol;
  • Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672164

Locations
United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
United States, Illinois
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44295
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Clinical Trials in Organ Transplantation
Investigators
Study Chair: Josh Levitsky, MD, MS Northwestern University Feinberg School of Medicine
Principal Investigator: Michael Abecassis, MD, MBA Northwestern University Feinberg School of Medicine
  More Information

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01672164     History of Changes
Other Study ID Numbers: DAIT CTOT-14 
Study First Received: August 16, 2012
Last Updated: September 1, 2016
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Data and Safety Monitoring Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: The plan is to share data in ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools that are available to researchers who register online and subsequently receive DAIT approval.

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
proteogenomic biomarker panels

ClinicalTrials.gov processed this record on December 09, 2016