AIIM Trial: Personalized Medicine Approach to Kidney Allograft Function

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT05432765
Status
Not Yet Recruiting

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Conditions

  • Kidney Transplant Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Phenotypic Personalized Medicine Dosing — OTHER
    Phenotypic Personalized Medicine (PPM) will mediate mechanism-independent and patient specific optimization of immunosuppression. We have developed a powerful platform that allows the provider to use clinical data to construct a Parabolic Response Surface (PRS). Using this visualization of the data, the provider can them make a decision on the optimal combination of drug doses needed to achieve the desired outcome.
  • Standard of Care Dosing — OTHER
    Providers will decide on the combination of drug doses needed based on their overall assessment per standard of care.

Study Details

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.

Key Dates

Start date
Dec 31, 2026
Status verified
Feb 2026
Primary completion
Aug 12, 2030
Completion
Jan 1, 2031

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Physician Dosing
    Subjects will continue per SOC, where the management of their immunosuppression regimen will be determined by their physician per center practices, including dd-cfDNA data.
  • Experimental: PPM Dosing
    Subjects will have dd-cfDNA data analyzed by PPM. Data, such as drug levels and regimens, will be used to fit a 2nd order polynomial for each patient to build patient-specific dose-response profiles with covariates that include the administered drugs tacrolimus, steroids, and MMF/MPA. PPM will be used to derive an optimal combination of tacrolimus, MMF/MPA, and prednisone to achieve minimal renal allograft injury, while staying within the therapeutic range of the medications. All else being equal, the most efficacious combination with the lowest dose of tacrolimus will be utilized.

Primary Outcome Measure

Change in renal allograft interstitial fibrosis (IF) between 3-month baseline up to 15-month follow-up. [ Time Frame: Change from 3-month baseline to 15-month follow-up ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Florida Health ShandsGainesvilleFlorida32610
Ali Zarrinpar, MD PhD
[email protected]
352-265-0606
Alfonso Santos, MD
[email protected]
(352) 273-8821

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By research site
University of Florida Health Shands· Gainesville, FL

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