Molecular Assessment and Profiling of Liver Transplant Recipients

Liver Transplantation Clinical Trial

— MAPLE  

Official title:

Molecular Assessment and Profiling of Liver Transplant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04793360
• Other study ID #: SN-C-00015
• Status: Recruiting
• Start date: May 26, 2021
• Est. completion date: March 31, 2028

Study information

• Verified date: February 2024
• Source: CareDx
• Contact: Anna Thomas
• Phone: (352) 359-1981
• Email: athomas[@]caredx.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: March 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Biomarkers
• Liver Transplantation

Intervention

Device:
• LiverCare
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Piedmont Healthcare	Atlanta	Georgia
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center (BIDMC)	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical Unversity of South Carolina	Charleston	South Carolina
United States	Atrium Health	Charlotte	North Carolina
United States	University of Cincinnati	Cincinnati	Ohio
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Methodist Health System	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University	Durham	North Carolina
United States	University of Iowa	Iowa City	Iowa
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Keck Medical Center of USC	Los Angeles	California
United States	University of Tennessee_Methodist Healthcare	Memphis	Tennessee
United States	Intermountain Medical Center	Murray	Utah
United States	Tulane University	New Orleans	Louisiana
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	INTEGRIS Baptist Medical Center	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center/ Nebraska Medicine	Omaha	Nebraska
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Washington Unversity in St. Louis	Saint Louis	Missouri
United States	University of Utah, Division of Transplantation & Advanced Hepatobiliary Surgery	Salt Lake City	Utah
United States	University of California San Diego	San Diego	California
United States	University of Washington	Seattle	Washington
United States	Tampa General Hospital	Tampa	Florida
United States	Westchester Medical Center	Valhalla	New York
United States	MedStar Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
CareDx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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'	2 years of accrual and 3 years follow up