AIIM Trial: Personalized Medicine Approach to Kidney Allograft Function
ConditionKidney Transplant Rejection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Phenotypic Personalized Medicine Dosing
- Standard of Care Dosing
Treatment groups
34 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov