Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine
PPM - Pro
2 other identifiers
interventional
62
2 countries
3
Brief Summary
Clinical trial applying Phenotypic Precision Medicine (PPM) to tacrolimus dosing in liver and/or kidney transplant recipients to show improvement in maintaining drug trough levels within the target range.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2018
Typical duration for phase_2
3 active sites
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
First Submitted
Initial submission to the registry
May 4, 2018
CompletedFirst Posted
Study publicly available on registry
May 17, 2018
CompletedStudy Start
First participant enrolled
September 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedResults Posted
Study results publicly available
December 10, 2021
CompletedDecember 10, 2021
December 1, 2021
1.7 years
May 4, 2018
November 12, 2021
December 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tacrolimus Target Trough Level Maintenance
Percentage of Days Far (\> 2 ng/mL) Out of Range of Tacrolimus Target Trough Level
2 weeks
Study Arms (2)
Standard of Care
ACTIVE COMPARATORStandard of Care Tacrolimus Drug Dosing
Phenotypic Precision Medicine (PPM)
EXPERIMENTALPPM-based Computation Assisted Drug Dosing
Interventions
Tacrolimus dosing based on application of PPM.
Dosing of calcineurin inhibitor, tacrolimus
Eligibility Criteria
You may qualify if:
- adults undergoing liver and/or kidney transplantation
You may not qualify if:
- transplant patients with contraindications to tacrolimus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
UCLA
Los Angeles, California, 90095, United States
UF Health at the University of Florida
Gainesville, Florida, 32610, United States
National University of Singapore
Singapore, 119077, Singapore
Related Publications (1)
Khong J, Lee M, Warren C, Kim UB, Duarte S, Andreoni KA, Shrestha S, Johnson MW, Battula NR, McKimmy DM, Beduschi T, Lee JH, Li DM, Ho CM, Zarrinpar A. Tacrolimus dosing in liver transplant recipients using phenotypic personalized medicine: A phase 2 randomized clinical trial. Nat Commun. 2025 May 16;16(1):4558. doi: 10.1038/s41467-025-59739-6.
PMID: 40379675DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ali Zarrinpar
- Organization
- University of Florida
Study Officials
- PRINCIPAL INVESTIGATOR
Ali Zarrinpar, MD PhD
University of Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2018
First Posted
May 17, 2018
Study Start
September 21, 2018
Primary Completion
June 2, 2020
Study Completion
August 31, 2021
Last Updated
December 10, 2021
Results First Posted
December 10, 2021
Record last verified: 2021-12