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OpenTrials
Completed

NCT Number: NCT01672164

Discovery and Validation of Proteogenomic Biomarker Panels in Liver Transplant Recipients

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.

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Key information

Conditions

Liver Transplant Recipients Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Acute Rejection

    Time frame: 3 months after liver transplant

    The primary endpoint is the incidence of biopsy proven AR at 3, 12 and 24 months after LT.

  2. Acute Rejection

    Time frame: 12 months after liver transplant

  3. Acute Rejection

    Time frame: 24 months after liver transplant

Secondary outcomes

  1. Severity of acute rejection

    Time frame: Baseline (Visit 1) to Month 24 (Visit 12):

    Severity (initial grade, steroid-responsive vs. refractory by biopsy) and clinical/biochemical resolution following treatment of AR

  2. Recurrent Hepatitis-C Virus (HCV-R)

    Time frame: Baseline (Visit 1) to Month 24 (Visit 12)

    Incidence, severity (grade, stage), and treatment (requirement for, response rates) of HCV-R

  3. Chronic Kidney Disease(CKD)

    Time frame: Baseline (Visit 1) to Month 24 (Visit 12)

    Incidence, severity (stage, need for renal replacement therapy or kidney transplantation), and response to treatment (CNI reduction/withdrawal ± MPA or mTOR) of CKD

  4. Incidence of death, graft loss, and need for liver retransplantation

    Time frame: Baseline (Visit 1) to Month 24 (Visit 12)

  5. Incidence of opportunistic infections, malignancy, and cardiovascular complications

    Time frame: Baseline (Visit 1) to Month 24 (Visit 12)

  6. mRNA expression profiles of peripheral blood (AR, HCV-R, CKD)

    Time frame: Baseline (Visit 1) to Month 24 (Visit 12)

  7. mRNA expression profiles of liver biopsies (AR, HCV-R)

    Time frame: Baseline (Visit 1) to Month 24 (Visit 12)

  8. Protein expression profiles of plasma ( AR, HCV-R, CKD)

    Time frame: Baseline (Visit 1) to Month 24 (Visit 12)

  9. Protein expression profiles of urine (CKD)

    Time frame: Baseline (Visit 1) to Month 24 (visit 12)

  10. microRNA Profiling Plasma & Cells

    Time frame: Baseline (Visit 1) to Month 24 (Visit 12)

  11. Multiparameter Flow Cytometry - Viral Pathogens

    Time frame: Baseline (Visit 1) to Month 24 (Visit 12)

  12. Viral Monitoring - EBV & CMV

    Time frame: Baseline (Visit 1) to Month 24 (Visit 12)

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Clinical Trials in Organ Transplantation

Registry information

Official study title

Discovery and Validation of Proteogenomic Biomarker Panels in a Prospective Serial Blood and Urine Monitoring Study of Liver Transplant Recipients - Transplant Proteogenomics

Acronym: PROGENI-LI

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 24, 2012
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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