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AIIM Trial: Personalized Medicine for Kidney Transplants

This study is testing a new way to adjust medicine doses for people who have received a kidney transplant. It compares a personalized approach called Phenotypic Personalized Medicine (PPM) to the standard way doctors decide on medicine doses. The goal is to see if PPM can better optimize immunosuppression, which is medicine that prevents your body from rejecting the new kidney. Researchers will look at changes in kidney scarring (interstitial fibrosis) between 3 and 15 months after transplant. You might be able to join if you are an adult (18-99 years old) with end-stage renal disease who has received a kidney transplant and is taking tacrolimus. The study plans to enroll 34 participants, but its current status is unclear.

Study design
This is a pilot study, meaning it's a small-scale test to see if the study design works and to gather initial information. It will involve 34 participants.
What's involved
You would be recruited one month after your kidney transplant if you don't have rejection. The study will monitor changes in your kidney scarring from 3 months up to 15 months after transplant.
Compensation
Not stated in the trial record.
Follow-up
Your kidney function will be followed up to 15 months after your transplant.

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NCT05432765

AIIM Trial: Personalized Medicine Approach to Kidney Allograft Function

Not Yet Recruiting
NAAges 18–99InterventionalTreatment
University of Florida
~34 participants
Updated 2026-02-10 on ClinicalTrials.gov
What's tested:Phenotypic Personalized Medicine DosingStandard of Care Dosing

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in renal allograft interstitial fibrosis (IF) between 3-month baseline up to 15-month follow-up.
Measured over Change from 3-month baseline to 15-month follow-up

Conditions

Kidney Transplant Rejection

Explore related trials

Kidney Transplantation

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Ali Zarrinpar, MD PhD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Ali Zarrinpar, MD PhD
[email protected]
352-265-0606
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 or historical panel reactive antibodies of more than 50%
Blood Type (ABO) incompatibility or known moderate or strong donor specific antibodies
De novo or recurrent glomerulonephritis on 3-month biopsy
Lupus nephritis on 3-month biopsy
Focal segmental glomerulosclerosis on 3-month biopsy
BK polyomavirus nephropathy in current or prior transplant
Recipient of a bone marrow transplant
Recipient who is pregnant
Enrollment in a competing trial that would interfere with selection or alteration of immunosuppression
Inability to follow up with transplant center for up to 15 months after transplantation
Anticipated major surgery during the time of planned study
Major medical illness with life expectancy less than 15 months
Suspicion of noncompliance
Anticipated relocation to a location that would not allow follow up at local center in the next 18 months
Inability to tolerate normal range levels of tacrolimus

What this trial measures

  • Change in renal allograft interstitial fibrosis (IF) between 3-month baseline up to 15-month follow-up.Change from 3-month baseline 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%.