Kidney Transplant RejectionAIIMNCT05432765
AIIM Trial: Personalized Medicine Approach to Kidney Allograft Function
A study testing Phenotypic Personalized Medicine Dosing in people with Kidney Transplant Rejection, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- Phenotypic Personalized Medicine Dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to 1 Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Florida Health Shands
Gainesville, Florida, 32610
Ali Zarrinpar, MD PhD, 352-265-0606, ali.zarrinpar@surgery.ufl.edu
Alfonso Santos, MD, (352) 273-8821, Alfonso.Santos@medicine.ufl.edu
About this study
Official title: AIIM Trial: Protecting Kidney Function After Transplantation Using Augmented Intelligence Based Immunosuppression Dosing
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.
Read the 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 randomized controlled trial (RCT). These goals will be achieved within the three year span of this program. The study has organized the investigator team to be able to achieve the following goals: 1) obtain regulatory approval, 2) optimize the clinical trial design, 3) recruit patients, 4) conduct the study, including optimization of immunosuppression regimen and monitoring the endpoints of interest, 5) conduct statistical analysis of the results, and 6) analyze the findings. Thirty-four subjects will be recruited at the time of kidney transplantation. Inclusion and exclusion criteria are listed below. All subjects will be started with institutional standard of care (SOC): quadruple immunosuppressive therapy with in-duction (basiliximab or antithymocyte globulin), tacrolimus, steroids, and mycophenolate mofetil/mycophenolic acid (MMF/MPA). Maintenance immunosuppression after transplantation will also be determined by the center per SOC. At recruitment, one month after transplantation, subjects without biopsy proven rejection will be recruited and enrolled in the baseline monitoring period of the study. Monitoring includes weekly dd-cfDNA (donor-derived cell-free DNA) measurements, drawn at the same time as SOC labs, up to three months after transplantation. Subjects will continue to be seen per clinical SOC Both SOC and dd-cfDNA labs will be obtained per patient preference (commercial lab, mobile phlebotomy, or at UF). Dd-cfDNA assessments will be performed at a Clinical Laboratory Improvement Amendments (CLIA)-approved centralized location per company standards. Clinical SOC includes an updated history and physical, including a full medication history, biochemical and hematological measurements, and drug exposure of tacrolimus monitored by obtaining trough level measurements. Three months after transplantation, a graft biopsy will be obtained and analyzed by an expert renal pathologist. Patients with evidence of rejection on biopsy will be excluded. Patients without rejection (Banff Classification 2018 active or chronic cellular or antibody mediated rejection) will undergo balanced randomization (1:1) to one of the following treatment arms:
- Control arm: 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.
- Treatment arm: 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 pro-files 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.
In either arm, if a change is made in the immunosuppression regimen, SOC and dd-cfDNA labs will be obtained one week later to assess for changes and for the regimen to be adjusted accordingly. If no change is made in the immunosuppression regimen, the subject will continue with their SOC labs and clinic visit schedule. All subjects will undergo a protocol biopsy at the completion of the study at 15 months (12 months after first biopsy).
- Conditions
- Kidney Transplant Rejection
- Being tested
- Phenotypic Personalized Medicine Dosing, Standard of Care Dosing
- Keywords
- Kidney, Transplant, dd-cf DNA, Personalized Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenotypic Personalized Medicine DosingOther
Phenotypic 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 DosingOther
Providers will decide on the combination of drug doses needed based on their overall assessment per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Physician Dosing | Active comparator | 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. Receives: Other: Standard of Care Dosing |
| PPM Dosing | Experimental | 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. Receives: Other: Phenotypic Personalized Medicine Dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Change from 3-month baseline to 15-month follow-up
Secondary outcomes (4)
Change in Creatinine Clearance
This is a quantitative measure of kidney function.
Measured: Change from 3-month baseline to 15-month follow-up
Change in tubular atrophy and vacuolization on biopsy
Used as markers of allograft function and chronic allograft injury.
Measured: Change from 3-month baseline to 15-month follow-up
24-hour proteinuria
This would be performed using a 24-hour urine collection method for the greatest accuracy.
Measured: Change from 3-month baseline to 15-month follow-up
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.
Measured: At 15-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study startDec 2026 (estimated)
- Primary completion12 Aug 2030 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Zarrinpar, MD PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432765
- Sponsor's protocol ID
- IRB202201106
- Acronym
- AIIM
- Status last verified
- Feb 2026
- First submitted
- 6 Jun 2022
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will use methods in place from previous and ongoing studies to customize a data management system for the AIIM Trial. Data from study visits will be acquired on paper and processed using a REDCap database provided by the UF Clinical and Translational Science Institute and stored on secure UF servers. Initial examination of data will include descriptive statistics, frequency distributions, and histograms to identify outliers and missing data and to check data source adequacy. This process will be supervised by the PI and lead statistician. Any entry error and/or inconsistency will be discussed during meetings with the study team. Quarterly statistical summaries and progress reports will be generated by the statisticians for review by all investigators. This will be delivered in the form of a web-based platform using the R Shiny app to closely monitor participants accrual and maximize data quality.
Publications
Zarrinpar A, Busuttil RW. Liver transplantation: past, present and future. Nat Rev Gastroenterol Hepatol. 2013 Jul;10(7):434-40. doi: 10.1038/nrgastro.2013.88. Epub 2013 Jun 11.
PubMed 23752825Starzl TE, Iwatsuki S, Shaw BW Jr, Gordon RD, Esquivel CO. Immunosuppression and other nonsurgical factors in the improved results of liver transplantation. Semin Liver Dis. 1985 Nov;5(4):334-43. doi: 10.1055/s-2008-1040630.
PubMed 3909427Tanzi MG, Undre N, Keirns J, Fitzsimmons WE, Brown M, First MR. Pharmacokinetics of prolonged-release tacrolimus and implications for use in solid organ transplant recipients. Clin Transplant. 2016 Aug;30(8):901-11. doi: 10.1111/ctr.12763. Epub 2016 Jun 18.
PubMed 27220013Marcen R. Immunosuppressive drugs in kidney transplantation: impact on patient survival, and incidence of cardiovascular disease, malignancy and infection. Drugs. 2009 Nov 12;69(16):2227-43. doi: 10.2165/11319260-000000000-00000.
PubMed 19852526Williams D, Haragsim L. Calcineurin nephrotoxicity. Adv Chronic Kidney Dis. 2006 Jan;13(1):47-55. doi: 10.1053/j.ackd.2005.11.001.
PubMed 16412970di Paolo S, Teutonico A, Stallone G, Infante B, Schena A, Grandaliano G, Battaglia M, Ditonno P, Schena PF. Cyclosporin exposure correlates with 1 year graft function and histological damage in renal transplanted patients. Nephrol Dial Transplant. 2004 Aug;19(8):2107-12. doi: 10.1093/ndt/gfh344. Epub 2004 Jun 8.
PubMed 15187199Fortin MC, Raymond MA, Madore F, Fugere JA, Paquet M, St-Louis G, Hebert MJ. Increased risk of thrombotic microangiopathy in patients receiving a cyclosporin-sirolimus combination. Am J Transplant. 2004 Jun;4(6):946-52. doi: 10.1111/j.1600-6143.2004.00428.x.
PubMed 15147429U.S. Multicenter FK506 Liver Study Group. A comparison of tacrolimus (FK 506) and cyclosporine for immunosuppression in liver transplantation. N Engl J Med. 1994 Oct 27;331(17):1110-5. doi: 10.1056/NEJM199410273311702.
PubMed 7523946Ekberg H, Grinyo J, Nashan B, Vanrenterghem Y, Vincenti F, Voulgari A, Truman M, Nasmyth-Miller C, Rashford M. Cyclosporine sparing with mycophenolate mofetil, daclizumab and corticosteroids in renal allograft recipients: the CAESAR Study. Am J Transplant. 2007 Mar;7(3):560-70. doi: 10.1111/j.1600-6143.2006.01645.x. Epub 2007 Jan 22.
PubMed 17229079Ekberg H, Bernasconi C, Tedesco-Silva H, Vitko S, Hugo C, Demirbas A, Acevedo RR, Grinyo J, Frei U, Vanrenterghem Y, Daloze P, Halloran P. Calcineurin inhibitor minimization in the Symphony study: observational results 3 years after transplantation. Am J Transplant. 2009 Aug;9(8):1876-85. doi: 10.1111/j.1600-6143.2009.02726.x. Epub 2009 Jun 26.
PubMed 19563339
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIIM Trial: Protecting Kidney Function After Transplantation Using Augmented Intelligence Based Immunosuppression Dosing
- ClinicalTrials.gov ID
- NCT05432765
- Acronym / sponsor ID
- AIIM / IRB202201106
- Conditions
- Kidney Transplant Rejection
- Keywords
- Kidney, Transplant, dd-cf DNA, Personalized Medicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- 12 Aug 2030 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 randomized controlled trial (RCT). These goals will be achieved within the three year span of this program. The study has organized the investigator team to be able to achieve the following goals: 1) obtain regulatory approval, 2) optimize the clinical trial design, 3) recruit patients, 4) conduct the study, including optimization of immunosuppression regimen and monitoring the endpoints of interest, 5) conduct statistical analysis of the results, and 6) analyze the findings. Thirty-four subjects will be recruited at the time of kidney transplantation. Inclusion and exclusion criteria are listed below. All subjects will be started with institutional standard of care (SOC): quadruple immunosuppressive therapy with in-duction (basiliximab or antithymocyte globulin), tacrolimus, steroids, and mycophenolate mofetil/mycophenolic acid (MMF/MPA). Maintenance immunosuppression after transplantation will also be determined by the center per SOC. At recruitment, one month after transplantation, subjects without biopsy proven rejection will be recruited and enrolled in the baseline monitoring period of the study. Monitoring includes weekly dd-cfDNA (donor-derived cell-free DNA) measurements, drawn at the same time as SOC labs, up to three months after transplantation. Subjects will continue to be seen per clinical SOC Both SOC and dd-cfDNA labs will be obtained per patient preference (commercial lab, mobile phlebotomy, or at UF). Dd-cfDNA assessments will be performed at a Clinical Laboratory Improvement Amendments (CLIA)-approved centralized location per company standards. Clinical SOC includes an updated history and physical, including a full medication history, biochemical and hematological measurements, and drug exposure of tacrolimus monitored by obtaining trough level measurements. Three months after transplantation, a graft biopsy will be obtained and analyzed by an expert renal pathologist. Patients with evidence of rejection on biopsy will be excluded. Patients without rejection (Banff Classification 2018 active or chronic cellular or antibody mediated rejection) will undergo balanced randomization (1:1) to one of the following treatment arms:
- Control arm: 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.
- Treatment arm: 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 pro-files 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.
In either arm, if a change is made in the immunosuppression regimen, SOC and dd-cfDNA labs will be obtained one week later to assess for changes and for the regimen to be adjusted accordingly. If no change is made in the immunosuppression regimen, the subject will continue with their SOC labs and clinic visit schedule. All subjects will undergo a protocol biopsy at the completion of the study at 15 months (12 months after first biopsy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physician Dosing | Active comparator | Other: Standard of Care DosingSubjects will continue per SOC, where the management of their immunosuppression regimen will be determined by their physician per center practices, including dd-cfDNA data. |
| PPM Dosing | Experimental | Other: Phenotypic Personalized Medicine DosingSubjects 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenotypic Personalized Medicine DosingPhenotypic 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. | Other | PPM Dosing |
| Standard of Care DosingProviders will decide on the combination of drug doses needed based on their overall assessment per standard of care. | Other | Physician Dosing |
Primary outcome
Change in renal allograft interstitial fibrosis (IF) between 3-month baseline up to 15-month follow-up.
Time frame: 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%.
4 secondary outcomes
Change in Creatinine Clearance
Time frame: Change from 3-month baseline to 15-month follow-up
Change in tubular atrophy and vacuolization on biopsy
Time frame: Change from 3-month baseline to 15-month follow-up
24-hour proteinuria
Time frame: Change from 3-month baseline to 15-month follow-up
Cumulative tacrolimus exposure
Time frame: At 15-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Results publication: PubMed 23752825Zarrinpar A, Busuttil RW. Liver transplantation: past, present and future. Nat Rev Gastroenterol Hepatol. 2013 Jul;10(7):434-40. doi: 10.1038/nrgastro.2013.88. Epub 2013 Jun 11.
- Results publication: PubMed 3909427Starzl TE, Iwatsuki S, Shaw BW Jr, Gordon RD, Esquivel CO. Immunosuppression and other nonsurgical factors in the improved results of liver transplantation. Semin Liver Dis. 1985 Nov;5(4):334-43. doi: 10.1055/s-2008-1040630.
- Results publication: PubMed 27220013Tanzi MG, Undre N, Keirns J, Fitzsimmons WE, Brown M, First MR. Pharmacokinetics of prolonged-release tacrolimus and implications for use in solid organ transplant recipients. Clin Transplant. 2016 Aug;30(8):901-11. doi: 10.1111/ctr.12763. Epub 2016 Jun 18.
- Results publication: PubMed 19852526Marcen R. Immunosuppressive drugs in kidney transplantation: impact on patient survival, and incidence of cardiovascular disease, malignancy and infection. Drugs. 2009 Nov 12;69(16):2227-43. doi: 10.2165/11319260-000000000-00000.
- Results publication: PubMed 16412970Williams D, Haragsim L. Calcineurin nephrotoxicity. Adv Chronic Kidney Dis. 2006 Jan;13(1):47-55. doi: 10.1053/j.ackd.2005.11.001.
- Results publication: PubMed 15187199di Paolo S, Teutonico A, Stallone G, Infante B, Schena A, Grandaliano G, Battaglia M, Ditonno P, Schena PF. Cyclosporin exposure correlates with 1 year graft function and histological damage in renal transplanted patients. Nephrol Dial Transplant. 2004 Aug;19(8):2107-12. doi: 10.1093/ndt/gfh344. Epub 2004 Jun 8.
- Results publication: PubMed 15147429Fortin MC, Raymond MA, Madore F, Fugere JA, Paquet M, St-Louis G, Hebert MJ. Increased risk of thrombotic microangiopathy in patients receiving a cyclosporin-sirolimus combination. Am J Transplant. 2004 Jun;4(6):946-52. doi: 10.1111/j.1600-6143.2004.00428.x.
- Results publication: PubMed 7523946U.S. Multicenter FK506 Liver Study Group. A comparison of tacrolimus (FK 506) and cyclosporine for immunosuppression in liver transplantation. N Engl J Med. 1994 Oct 27;331(17):1110-5. doi: 10.1056/NEJM199410273311702.
- Results publication: PubMed 17229079Ekberg H, Grinyo J, Nashan B, Vanrenterghem Y, Vincenti F, Voulgari A, Truman M, Nasmyth-Miller C, Rashford M. Cyclosporine sparing with mycophenolate mofetil, daclizumab and corticosteroids in renal allograft recipients: the CAESAR Study. Am J Transplant. 2007 Mar;7(3):560-70. doi: 10.1111/j.1600-6143.2006.01645.x. Epub 2007 Jan 22.
- Results publication: PubMed 19563339Ekberg H, Bernasconi C, Tedesco-Silva H, Vitko S, Hugo C, Demirbas A, Acevedo RR, Grinyo J, Frei U, Vanrenterghem Y, Daloze P, Halloran P. Calcineurin inhibitor minimization in the Symphony study: observational results 3 years after transplantation. Am J Transplant. 2009 Aug;9(8):1876-85. doi: 10.1111/j.1600-6143.2009.02726.x. Epub 2009 Jun 26.
- Individual participant dataSharing planned: No. The investigators will use methods in place from previous and ongoing studies to customize a data management system for the AIIM Trial. Data from study visits will be acquired on paper and processed using a REDCap database provided by the UF Clinical and Translational Science Institute and stored on secure UF servers. Initial examination of data will include descriptive statistics, frequency distributions, and histograms to identify outliers and missing data and to check data source adequacy. This process will be supervised by the PI and lead statistician. Any entry error and/or inconsistency will be discussed during meetings with the study team. Quarterly statistical summaries and progress reports will be generated by the statisticians for review by all investigators. This will be delivered in the form of a web-based platform using the R Shiny app to closely monitor participants accrual and maximize data quality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of Florida Health Shands
Gainesville, United States
Ali Zarrinpar, MD PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenotypic Personalized Medicine Dosing in people with Kidney Transplant Rejection, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in renal allograft interstitial fibrosis (IF) between 3-month baseline up to 15-month follow-up. (time frame: Change from 3-month baseline to 15-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05432765, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.