Liver TransplantationMAPLENCT04793360
Molecular Assessment and Profiling of Liver Transplant Recipients
An observational study of Liver Transplantation and Biomarkers, run by CareDx at 26 sites in United States.
Trial summary
The objective of this protocol is to conduct longitudinal and prospective studies of liver transplant recipients, using a multimodality approach, akin to that used in kidney transplantation. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Liver Transplantation, Biomarkers
- What is being tested?
- LiverCare
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 26 sitesUnited States
- Study dates
- 26 May 2021to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All liver transplant patients without exclusion criteria will be eligible to enter the study. Patients will be approached by the study team at the time of transplant or within 60 days post-transplant to discuss the trial, consent and enrollment.
Who may be able to join
- Liver transplant recipients <60 days post-transplant (de-novo or re-transplant).
- Participant is willing and able to give informed consent for participation in the trial.
- Male or Female, aged 12 years or above (Gillick Competent).
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
Who cannot join
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- Has evidence of significant post-transplant impairment of hepatic function which is unlikely to improve (determined by the PI).
- Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- Participant with life expectancy of less than 6 months or is inappropriate for diagnostic monitoring through regular blood sampling.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- Participants who have participated in another research trial involving an investigational product in the past 12 weeks*.
- Multi-organ transplant recipients or dual organ transplant recipients.
- Patients with significant needle phobia.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
University of Michigan
Ann Arbor, Michigan, 48109
Piedmont Healthcare
Atlanta, Georgia, 30309
University of Maryland Medical Center
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02215
Medical Unversity of South Carolina
Charleston, South Carolina, 29425
Atrium Health
Charlotte, North Carolina, 28204
University of Cincinnati
Cincinnati, Ohio, 45267
Methodist Health System
Dallas, Texas, 75203
Henry Ford Health System
Detroit, Michigan, 48202
Duke University
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66160
Keck Medical Center of USC
Los Angeles, California, 90033
University of Tennessee_Methodist Healthcare
Memphis, Tennessee, 38104
Intermountain Medical Center
Murray, Utah, 84107
Tulane University
New Orleans, Louisiana, 70112
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
University of Nebraska Medical Center/ Nebraska Medicine
Omaha, Nebraska, 68198
Virginia Commonwealth University
Richmond, Virginia, 23219
University of Washington
Seattle, Washington, 98195
Washington Unversity in St. Louis
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
Westchester Medical Center
Valhalla, New York, 10595
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
The objective of this protocol is to conduct longitudinal and prospective studies of liver transplant recipients, using a multimodality approach, akin to that used in kidney transplantation. The primary aim will compare the clinical outcomes of LiverCare post-transplant surveillance in liver transplant with standard of care consisting of liver function tests, DSA measurements, drug level monitoring, and 'for cause' biopsy. The protocol will assess the correlation between clinical events (e.g. rejection, recurrent disease, biliary obstruction), dd-cfDNA levels, gene expression profiling, ability to assess microchimerism, develop predictive analytics, infectious disease diagnoses and finally examine graft histology.
- Conditions
- Liver Transplantation, Biomarkers
- Being tested
- LiverCare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiverCareDevice
The LiverCare kits contains Streck tubes and PAX gene tubes, which will be collected at the surveillance schedule outlined above, but also prior to any liver biopsy or DSA measurement. For patients who have a histological diagnosis of allograft rejection who are undergoing treatment, serial monitoring of LiverCare will be performed following the schedule above. All research blood tests will be timed with standard clinical testing to avoid any additional needle sticks.
| Study group | Role | What they receive |
|---|---|---|
| LiverCare Surveillance | Participants undergoing orthotopic liver transplant (de-novo or re-transplant) will be considered for this study Receives: Device: LiverCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
To correlate the results of LiverCare with clinically significant events impacting post-transplant clinical outcomes, histological findings, and the development of de novo Donor Specific Antibody (DSA)
LiverCare will be measured 7 times in year 1 and quarterly each year. A total of 15 surveillance points per subject in addition to for-cause testing based on clinical changes. Liver care will be collected at the time of all histologic analyses whether 'for cause' or 'surveillance'
Measured: 2 years of accrual and 3 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start26 May 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CareDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kanish Mohib, PhD, Study director, CareDx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793360
- Sponsor's protocol ID
- SN-C-00015
- Acronym
- MAPLE
- Status last verified
- Sep 2026
- First submitted
- 8 Mar 2021
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Assessment and Profiling of Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT04793360
- Acronym / sponsor ID
- MAPLE / SN-C-00015
- Conditions
- Liver Transplantation, Biomarkers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- CareDxIndustry (pharma, biotech, devices)
- Study start
- 26 May 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 11 Mar 2021 (actual)
- 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 objective of this protocol is to conduct longitudinal and prospective studies of liver transplant recipients, using a multimodality approach, akin to that used in kidney transplantation. The primary aim will compare the clinical outcomes of LiverCare post-transplant surveillance in liver transplant with standard of care consisting of liver function tests, DSA measurements, drug level monitoring, and 'for cause' biopsy. The protocol will assess the correlation between clinical events (e.g. rejection, recurrent disease, biliary obstruction), dd-cfDNA levels, gene expression profiling, ability to assess microchimerism, develop predictive analytics, infectious disease diagnoses and finally examine graft histology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LiverCare Surveillance | – | Device: LiverCareParticipants undergoing orthotopic liver transplant (de-novo or re-transplant) will be considered for this study |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All liver transplant patients without exclusion criteria will be eligible to enter the study. Patients will be approached by the study team at the time of transplant or within 60 days post-transplant to discuss the trial, consent and enrollment.
Key inclusion criteria (4 listed)
- Liver transplant recipients <60 days post-transplant (de-novo or re-transplant).
- Participant is willing and able to give informed consent for participation in the trial.
- Male or Female, aged 12 years or above (Gillick Competent).
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
Key exclusion criteria (8 listed)
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- Has evidence of significant post-transplant impairment of hepatic function which is unlikely to improve (determined by the PI).
- Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- Participant with life expectancy of less than 6 months or is inappropriate for diagnostic monitoring through regular blood sampling.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiverCareThe LiverCare kits contains Streck tubes and PAX gene tubes, which will be collected at the surveillance schedule outlined above, but also prior to any liver biopsy or DSA measurement. For patients who have a histological diagnosis of allograft rejection who are undergoing treatment, serial monitoring of LiverCare will be performed following the schedule above. All research blood tests will be timed with standard clinical testing to avoid any additional needle sticks. | Device | LiverCare Surveillance |
Primary outcome
To correlate the results of LiverCare with clinically significant events impacting post-transplant clinical outcomes, histological findings, and the development of de novo Donor Specific Antibody (DSA)
Time frame: 2 years of accrual and 3 years follow up
LiverCare will be measured 7 times in year 1 and quarterly each year. A total of 15 surveillance points per subject in addition to for-cause testing based on clinical changes. Liver care will be collected at the time of all histologic analyses whether 'for cause' or 'surveillance'
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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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.
Kanish Mohib, PhD study director
CareDx
26 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 Transplantation and Biomarkers, run by CareDx at 26 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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 3 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 26 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?
This study is still under way. Results are not available in the source record yet.
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?
To correlate the results of LiverCare with clinically significant events impacting post-transplant clinical outcomes, histological findings, and the development of de novo Donor Specific Antibody (DSA) (time frame: 2 years of accrual and 3 years follow up). 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 3 Sep 2026.