AIIM Trial: Protecting Kidney Function After Transplantation Using Augmented Intelligence Based Immunosuppression Dosing
University of Florida
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.
Description
In this pilot/feasibility trial the investigators will assess the feasibility of the trial design described below and perform a pilot study to obtain information for the design of a future multicenter randomized controlled trial (RCT). These goals will be achieved within the three year span of this program. The study has organized the investigator team to be able to achieve the following goals: 1) obtain regulatory approval, 2) optimize the clinical trial design, 3) recruit patients, 4) conduct the study, including optimization of immunosuppression regimen and monitoring the endpoints of inter…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adult (18 years of age or older) patients with end-stage renal disease (ESRD) * Recipient of a first or subsequent deceased donor kidney transplant * Clinical indication to receive tacrolimus as the primary immunosuppression * Willing and able to provide written informed consent to participate Exclusion Criteria: * Recipients of transplanted organs other than kidney * Recipients of a transplant from a monozygotic (identical) sibling * Human Leukocyte Antigen (HLA)-identical donor (zero out of six antigen mismatch donor) * Recipient of third or more transplant * Current…
Interventions
- OtherPhenotypic Personalized Medicine Dosing
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.
- OtherStandard of Care Dosing
Providers will decide on the combination of drug doses needed based on their overall assessment per standard of care.
Location
- University of Florida Health ShandsGainesville, Florida