AIIM Trial: Personalized Medicine Approach to Kidney Allograft Function (NCT05432765) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
AIIM Trial: Personalized Medicine Approach to Kidney Allograft Function
United States34 participantsStarted 2026-12
Plain-language 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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in renal allograft interstitial fibrosis (IF) between 3-month baseline up to 15-month follow-up.
Timeframe: Change from 3-month baseline to 15-month follow-up