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Phenotypic Precision Medicine
Personalized Medicine Dosing for Kidney Transplant Rejection (AIIM Trial)
Phase < 1
Waitlist Available
Led By Ali Zarrinpar, MD PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical indication to receive tacrolimus as the primary immunosuppression
Adult (18 years of age or older) patients with end-stage renal disease (ESRD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from 3-month baseline to 15-month follow-up
Awards & highlights
AIIM Trial Summary
This trial is to establish the feasibility of using a computer-based approach to optimize combination drug therapy, and to gather preliminary data to support a larger trial.
Who is the study for?
This trial is for adults over 18 with end-stage renal disease who have received a kidney transplant and need tacrolimus immunosuppression. They must be able to consent and follow up at the center for 15 months. It's not for those intolerant to tacrolimus, with certain donor mismatches, multiple transplants, high antibody levels, incompatible blood types, specific kidney diseases on biopsy, prior bone marrow transplant or pregnancy.Check my eligibility
What is being tested?
The AIIM Trial tests a computational method called Phenotypic Personalized Medicine Dosing to optimize drug therapy in kidney transplant patients. This pilot study aims to prove it's feasible and gather data for a larger trial by using this approach specifically with tacrolimus dosing.See study design
What are the potential side effects?
While the trial description does not specify side effects directly related to the intervention being tested (PPM), typical risks may include issues related to incorrect dosing of medications such as tacrolimus which can lead to either increased risk of rejection or toxicity.
AIIM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need tacrolimus as my main immune system suppressant.
Select...
I am an adult with end-stage kidney disease.
Select...
I have received a kidney transplant from a deceased donor.
AIIM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from 3-month baseline to 15-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from 3-month baseline to 15-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in renal allograft interstitial fibrosis (IF) between 3-month baseline up to 15-month follow-up.
Secondary outcome measures
24-hour proteinuria
Change in Creatinine Clearance
Change in tubular atrophy and vacuolization on biopsy
+1 moreAIIM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PPM DosingExperimental Treatment1 Intervention
Subjects will have dd-cfDNA data analyzed by PPM. Data, such as drug levels and regimens, will be used to fit a 2nd order polynomial for each patient to build patient-specific dose-response profiles with covariates that include the administered drugs tacrolimus, steroids, and MMF/MPA. PPM will be used to derive an optimal combination of tacrolimus, MMF/MPA, and prednisone to achieve minimal renal allograft injury, while staying within the therapeutic range of the medications. All else being equal, the most efficacious combination with the lowest dose of tacrolimus will be utilized.
Group II: Physician DosingActive Control1 Intervention
Subjects will continue per SOC, where the management of their immunosuppression regimen will be determined by their physician per center practices, including dd-cfDNA data.
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,671 Total Patients Enrolled
Ali Zarrinpar, MD PhDPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
62 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I received a transplant from my identical twin.I need tacrolimus as my main immune system suppressant.My biopsy from 3 months ago shows I have lupus affecting my kidneys.I have blood type incompatibility or strong antibodies against a donor.My kidney biopsy shows new or returning inflammation.I have received an organ transplant, but it was not a kidney.I have had BK virus infection in my kidney after a transplant.I am an adult with end-stage kidney disease.I have received a kidney transplant from a deceased donor.My donor is a perfect HLA match.My biopsy shows focal segmental glomerulosclerosis.I cannot tolerate the drug tacrolimus at normal doses.My doctor expects me to live more than 15 months.I have received a bone marrow transplant.I expect to have major surgery during the study period.
Research Study Groups:
This trial has the following groups:- Group 1: Physician Dosing
- Group 2: PPM Dosing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age limit for this research project set at 45 years or older?
"Eligible patients must be over 18 and younger than 99 to be included in this trial."
Answered by AI
Are there any contraindications to participating in this clinical trial?
"Individuals who have rejection; transplant, kidney and are aged 18 to 99 may be eligible for this trial. Up to 34 people in total will be accepted."
Answered by AI
Are researchers still looking for study participants?
"Unfortunately, this particular clinical trial is not searching for patients at the moment. Although the last update was on August 25th, 2022, the study was originally posted on October 1st, 2022. Although this study is not recruiting candidates anymore, there are 31 other trials presently searching for patients right now."
Answered by AI
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