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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Phenotypic Personalized Medicine Dosing
Other interventionPhenotypic 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 interventionProviders will decide on the combination of drug doses needed based on their overall assessment per standard of care.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Physician DosingActive comparator 1 intervention
Group B: PPM DosingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in renal allograft interstitial fibrosis (IF) between 3-month baseline up to 15-month follow-up.
Multiple studies have used this outcome because it 1) correlates well with renal function as measured by Creatinine Clearance (CrCl), 2) is a quantitative, continuous, and objective measure, thus needing fewer subjects to show a difference between groups in a small study, and 3) it is less susceptible to acute fluctuations than CrCl and more reflective of chronic injury. Renal allograft IF is a continuous variable that ranges from 0 to 100%.
Time frame
Change from 3-month baseline to 15-month follow-upSecondary outcomes
1
Change in Creatinine Clearance
This is a quantitative measure of kidney function.
Time frame
Change from 3-month baseline to 15-month follow-up2
Change in tubular atrophy and vacuolization on biopsy
Used as markers of allograft function and chronic allograft injury.
Time frame
Change from 3-month baseline to 15-month follow-up3
24-hour proteinuria
This would be performed using a 24-hour urine collection method for the greatest accuracy.
Time frame
Change from 3-month baseline to 15-month follow-up4
Cumulative tacrolimus exposure
Measured by a summation of total tacrolimus dose over the 12 months of study dosing and by the integration of the cumulative tacrolimus trough levels over the study period.
Time frame
At 15-month follow-upSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: