Proteogenomic Monitoring and Assessment of Liver Transplant Recipients ("Mini-Liver")

May 20, 2026 updated by: Amna Daud, Northwestern University
This study is being done to test blood, urine and tissue samples to see if this can help decide if CKD (Chronic Kidney Disease), AR (Acute Rejection) and HCV (Hepatitis C Virus) can be identified in its early stages. CKD damage to the kidneys, AR and HCV all lower the body's ability to function properly. Early detection of these conditions could assist with successful treatment and possibly lead to less repeat organ transplants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

With the advent of more sensitive molecular techniques, biomarkers of kidney transplant rejection have been proposed that are potentially much more sensitive, specific and rapidly testable than conventional predictors of graft function such as GFR or tissue biopsies. Some of the early biomarkers during this evolution were the Cytotoxic T-cell (CTL) transcripts like perforin, granzyme B and fas ligand 11-13 for acute rejection. In the case of CAN/IFTA and CKD the molecular mechanisms and testable biomarkers also remain unclear. A few studies have reported the involvement of TGF-beta, extracellular matrix proteins like fibronectin and thrombopondin and tissue inhibitors of metalloproteins (TIMPs) as being upregulated in patients with Chronic Allograft Nephropathy (CAN/IFTA). Most of these studies were done in kidney transplant biopsies and the challenge of testing their expression and correlation in PBL as a minimally invasive tool was only addressed in a few studies. Another limitation of these first studies was the lack of the power to profile genes globally. To this end the advent of DNA microarrays has brought about a quantum leap in the ability to profile thousands of genes simultaneously. Thus far, microarray analysis has been reported in kidney transplant studies implicating gene signatures for acute rejection in transplant biopsies as well as for the first time by us in peripheral blood. To our knowledge only two studies have tried to profile CAN/IFTA in peripheral blood. A recent study attempted to validate three genes that were derived from a microarray analysis of kidney biopsies using RT-qPCR. All three genes were significantly differentially expressed in urine but not in PBL. Another study using microarrays showed that among a panel of 49 peripheral blood genes that were purported to distinguish "operational tolerance" in kidney rejection, 33 genes could also distinguish "chronic rejection" with 86% specificity.

Most of the studies in the literature, including our own, as well as our more recent unpublished peripheral blood gene expression studies of AR and CAN/IFTA reveal clear molecular signatures for both these forms of transplant outcomes. In sum, these data establish a first proof of concept that peripheral blood gene expression profiling can be used to develop markers of kidney allograft rejection and chronic kidney injury.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The intention of our biomarker panel is to be broadly applicable to all patients with liver transplant with the assumption that there are common underlying molecular mechanisms of CKD and AR (and HCV) that can be detected hopefully at early stages of disease. We therefore want to validate and test our biomarker panel in a broad collection of patient types.

Description

Inclusion Criteria:

  1. Male and female recipients of all races, ≥18 years of age.
  2. Patients undergoing primary or subsequent living or deceased donor liver transplantation.
  3. Subject and/or guardian must be able to provide informed consent.
  4. Subject and/or guardian must be able to comply with the study protocol.

Exclusion Criteria:

1. Inability or unwillingness of a participant and/or guardian to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proteogenomic Biomarkers for CKD, AR and HCV
Time Frame: At time of liver biopsy
To validate specific proteogenomic biomarker panels for CKD and AR (and HCV) in a prospective serial blood and urine monitoring study of liver transplant recipients
At time of liver biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scripps Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Josh Levitsky, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU 26737

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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