PPM Dosing for Rejection; Transplant, Kidney

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Florida Health Shands, Gainesville, FL
Rejection; Transplant, Kidney
Phenotypic Personalized Medicine Dosing - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The objective of the proposed study it to perform a pilot clinical trial both to establish feasibility of applying a computational, augmented intelligence based approach, Phenotypic Precision Medicine (PPM), to optimizing combination drug therapy and to gather preliminary data to support a larger fully powered multi-center clinical trial. The key rationale for this clinical selection is that we have the technical, biological, and medical expertise in this disease, a wealth of experience in the use of PPM in both in vitro and the clinical setting, and a robust and integrated transplant program with a well-functioning clinical trial infrastructure.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Change from 3-month baseline to 15-month follow-up

At 15-month follow-up
Cumulative tacrolimus exposure
Change from 3-month baseline to 15-month follow-up
24-hour proteinuria
Change in Creatinine Clearance
Change in renal allograft interstitial fibrosis (IF) between 3-month baseline up to 15-month follow-up.
Change in tubular atrophy and vacuolization on biopsy

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Physician Dosing
1 of 2
PPM Dosing
1 of 2
Active Control
Experimental Treatment

34 Total Participants · 2 Treatment Groups

Primary Treatment: PPM Dosing · No Placebo Group · Phase < 1

PPM Dosing
Other
Experimental Group · 1 Intervention: Phenotypic Personalized Medicine Dosing · Intervention Types: Other
Physician Dosing
Other
ActiveComparator Group · 1 Intervention: Phenotypic Personalized Medicine Dosing · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from 3-month baseline to 15-month follow-up
Closest Location: University of Florida Health Shands · Gainesville, FL
Photo of Gainesville  1Photo of Gainesville  2
N/AFirst Recorded Clinical Trial
1 TrialsResearching Rejection; Transplant, Kidney
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a recipient of a deceased donor kidney transplant.
You have a clinical indication to receive tacrolimus as the primary immunosuppression.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References