NCT06063213

Brief Summary

To develop a prospective quantitative liver allograft monitoring protocol and retrospectively validate the use of Phenotypic personalized medicine (PPM) in immunosuppression dosing in liver transplant recipients.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Dec 2023Oct 2026

First Submitted

Initial submission to the registry

September 26, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

September 26, 2023

Last Update Submit

March 3, 2026

Conditions

Transplant Complication

Outcome Measures

Primary Outcomes (1)

  • Episodes of rejection

    Patients will be followed for six months after transplantation according to standard of care. Episodes of biopsy proven rejection will be counted.

    6 months

Secondary Outcomes (1)

  • Episodes of infection

    6 months

Study Arms (2)

Liver Transplant Group

Patients \<1 month post-surgery for liver transplant only.

Liver-Kidney Transplant Group

Patients \<1 month post-surgery for simultaneous kidney-liver transplant only.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that are simultaneous Liver Kidney Transplant recipients that are one month post transplant. Patients that are Liver Transplant recipients that are one month post transplant.

You may qualify if:

  • At least 18 years of age
  • At least one-month post-transplant
  • Recipient of a liver transplant alone or a simultaneous liver-kidney transplant

You may not qualify if:

  • Unwilling to provide informed consent
  • Recipient of a previous bone marrow or stem cell transplant
  • Pregnant
  • Unlikely to be able to comply with the study requirements, as determined by the PI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 2, 2023

Study Start

December 15, 2023

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

US(1)