Liver Transplant RecipientsPROGENI-LINCT01672164
Discovery and Validation of Proteogenomic Biomarker Panels in Liver Transplant Recipients
An observational study of Liver Transplant Recipients and Liver Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Recipients, Liver Transplantation
- How many people
- 202 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Liver Transplant Recipients
Who may be able to join
- Subjects undergoing primary deceased-donor or living donor liver transplantation;
- Subject must be able to understand and provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611
Cleveland Clinic Foundation
Cleveland, Ohio, 44295
Baylor University Medical Center
Dallas, Texas, 75246
Mount Sinai School of Medicine
New York, New York, 10029
Mayo Clinic
Phoenix, Arizona, 85054
About this study
Official title: Discovery and Validation of Proteogenomic Biomarker Panels in a Prospective Serial Blood and Urine Monitoring Study of Liver Transplant Recipients - Transplant Proteogenomics
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.
- Conditions
- Liver Transplant Recipients, Liver Transplantation
- Keywords
- proteogenomic biomarker panels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Liver Transplant Recipients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Rejection
The primary endpoint is the incidence of biopsy proven AR at 3, 12 and 24 months after LT.
Measured: 3 months after liver transplant
Acute Rejection
Measured: 12 months after liver transplant
Acute Rejection
Measured: 24 months after liver transplant
Secondary outcomes (12)
Severity of acute rejection
Severity (initial grade, steroid-responsive vs. refractory by biopsy) and clinical/biochemical resolution following treatment of AR
Measured: Baseline (Visit 1) to Month 24 (Visit 12):
Recurrent Hepatitis-C Virus (HCV-R)
Incidence, severity (grade, stage), and treatment (requirement for, response rates) of HCV-R
Measured: Baseline (Visit 1) to Month 24 (Visit 12)
Chronic Kidney Disease(CKD)
Incidence, severity (stage, need for renal replacement therapy or kidney transplantation), and response to treatment (CNI reduction/withdrawal ± MPA or mTOR) of CKD
Measured: Baseline (Visit 1) to Month 24 (Visit 12)
Incidence of death, graft loss, and need for liver retransplantation
Measured: Baseline (Visit 1) to Month 24 (Visit 12)
Incidence of opportunistic infections, malignancy, and cardiovascular complications
Measured: Baseline (Visit 1) to Month 24 (Visit 12)
mRNA expression profiles of peripheral blood (AR, HCV-R, CKD)
Measured: Baseline (Visit 1) to Month 24 (Visit 12)
mRNA expression profiles of liver biopsies (AR, HCV-R)
Measured: Baseline (Visit 1) to Month 24 (Visit 12)
Protein expression profiles of plasma ( AR, HCV-R, CKD)
Measured: Baseline (Visit 1) to Month 24 (Visit 12)
Protein expression profiles of urine (CKD)
Measured: Baseline (Visit 1) to Month 24 (visit 12)
microRNA Profiling Plasma & Cells
Measured: Baseline (Visit 1) to Month 24 (Visit 12)
Multiparameter Flow Cytometry - Viral Pathogens
Measured: Baseline (Visit 1) to Month 24 (Visit 12)
Viral Monitoring - EBV & CMV
Measured: Baseline (Visit 1) to Month 24 (Visit 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Clinical Trials in Organ Transplantation
- Responsible party
- Sponsor
- Investigators
- Josh Levitsky, MD, MS, Study chair, Northwestern UniversityMichael Abecassis, MD, MBA, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672164
- Sponsor's protocol ID
- DAIT CTOT-14
- Acronym
- PROGENI-LI
- Status last verified
- Sep 2026
- First submitted
- 16 Aug 2012
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery and Validation of Proteogenomic Biomarker Panels in a Prospective Serial Blood and Urine Monitoring Study of Liver Transplant Recipients - Transplant Proteogenomics
- ClinicalTrials.gov ID
- NCT01672164
- Acronym / sponsor ID
- PROGENI-LI / DAIT CTOT-14
- Conditions
- Liver Transplant Recipients, Liver Transplantation
- Keywords
- proteogenomic biomarker panels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Clinical Trials in Organ Transplantation
- Study start
- Aug 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Transplant Recipients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver Transplant Recipients
Key inclusion criteria (2 listed)
- Subjects undergoing primary deceased-donor or living donor liver transplantation;
- Subject must be able to understand and provide informed consent.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Acute Rejection
Time frame: 12 months after liver transplant
Acute Rejection
Time frame: 24 months after liver transplant
12 secondary outcomes
Severity of acute rejection
Time frame: Baseline (Visit 1) to Month 24 (Visit 12):
Recurrent Hepatitis-C Virus (HCV-R)
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
Chronic Kidney Disease(CKD)
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
Incidence of death, graft loss, and need for liver retransplantation
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
Incidence of opportunistic infections, malignancy, and cardiovascular complications
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
mRNA expression profiles of peripheral blood (AR, HCV-R, CKD)
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
mRNA expression profiles of liver biopsies (AR, HCV-R)
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
Protein expression profiles of plasma ( AR, HCV-R, CKD)
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
Protein expression profiles of urine (CKD)
Time frame: Baseline (Visit 1) to Month 24 (visit 12)
microRNA Profiling Plasma & Cells
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
Multiparameter Flow Cytometry - Viral Pathogens
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
Viral Monitoring - EBV & CMV
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
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Recruiting
Peer Support for Liver Transplant Recipients With History of ALD
Alcohol Use Disorder, Alcohol Related Liver Disease
Active, not recruitingPhase 4
Semaglutide vs Sitagliptin
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josh Levitsky, MD, MS study chair
Northwestern University
Michael Abecassis, MD, MBA principal investigator
Northwestern University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant Recipients and Liver Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Rejection (time frame: 3 months after liver transplant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.