Status:
NOT_YET_RECRUITING
AIIM Trial: Personalized Medicine Approach to Kidney Allograft Function
Lead Sponsor:
University of Florida
Conditions:
Kidney Transplant Rejection
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief 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...
Detailed Description
In this pilot/feasibility trial the investigators will assess the feasibility of the trial design described below and perform a pilot study to obtain information for the design of a future multicenter...
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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05432765
Start Date
December 1 2025
End Date
January 1 2027
Last Update
January 27 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Florida Health Shands
Gainesville, Florida, United States, 32610