Solid Organ TransplantPhase 4BRUNO-PICNCT06529536
Utilising Genotype Informed Bayesian Dosing of Tacrolimus in Children Post Solid Organ Transplantation.
A Phase 4 study testing Genotyping for CYP3A4 and CYP3A5 genes, Use of NextDose platform and Tacrolimus in people with Solid Organ Transplant, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial summary
This study aims to evaluate the efficacy of genotype-informed Bayesian dosing of tacrolimus in optimising drug exposure among paediatric solid organ transplant recipients. By tailoring tacrolimus dosage based on individual genetic makeup and using Bayesian modeling to predict drug levels, the researchers hope to… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Solid Organ Transplant
- What is being tested?
- Genotyping for CYP3A4 and CYP3A5 genes, Use of NextDose platform and Tacrolimus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Aug 2024to 2 Aug 2027
- Phase
- Phase 4
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 1-18 years of age
- Kidney, liver or heart transplant recipients
- Participant and/or parent consent to the study (prospective arm only)
Who cannot join
- Previous liver transplant.
- Lung OR Intestinal transplant.
- Insufficient time before transplant for pharmacogenomic analysis (prospective arm only)
- Immunosuppressant regimen not containing tacrolimus immediate release product
- Known hypersensitivity to tacrolimus and/or its formulation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Royal Children's Hospital
Melbourne, Victoria, 3052
Dhrita Khatri, 03 9936 6087, pharmaco.genomics@mcri.edu.au
David Metz, 03 9345 5533, david.metz@rch.org.au
About this study
Official title: Genotype Informed Bayesian Dosing of Tacrolimus in Solid Organ Transplant- Pharmacogenomic Implementation in Children
This study aims to evaluate the efficacy of genotype-informed Bayesian dosing of tacrolimus in optimising drug exposure among paediatric solid organ transplant recipients. By tailoring tacrolimus dosage based on individual genetic makeup and using Bayesian modeling to predict drug levels, the researchers hope to increase the likelihood of achieving therapeutic drug concentrations while minimising the risk of adverse events associated with subtherapeutic or supratherapeutic exposure.
Read the detailed description
Tacrolimus, a calcineurin inhibitor is an effective immunosuppressant for solid organ transplants (SOT). Due to its narrow therapeutic index and individual variability in its pharmacokinetics (PK), this can lead to inefficacy, toxicities and suboptimal outcomes.
Tacrolimus is typically administered orally twice daily, with a starting dose scaled linearly to body weight (mg/kg). Dose is then adjusted based on measured steady-state trough (pre-dose) whole blood tacrolimus concentrations, to bring to within a desired "therapeutic range". However, this dosing strategy remains associated with incomplete effectiveness and toxicities in a substantial proportion of recipients, related to under- or over-exposure respectively.
Cytochrome P450 CYP3A4 and CYP3A5 enzymes metabolise tacrolimus, with research suggesting a link between genetic variants for these isoenzymes and achievement of tacrolimus target levels. Genotyping for the CYP3A5 \& CYP3A4 gene prior to SOT can identify individuals who are at risk of high or low tacrolimus levels, and guide tacrolimus dosing prior to transplantation. Bayesian prediction is a pharmaco-statistical technique that uses population pharmacokinetic data and individual patient characteristics to accurately predict the tacrolimus dose required to achieve a target concentration. Subtherapeutic levels post-transplant, increases the risk of acute rejection. Furthermore, failure to maintain the target tacrolimus range for the first 6 months significantly raises the chance of rejection, donor-specific antibody formation and graft loss.
Genotype informed dosing algorithms may optimise and ameliorate sub-therapeutic levels, thus potentially reducing the risk of rejection or toxicity, with subsequent Bayesian dosing increasing time within the range of safe and effective concentrations in the subsequent weeks (as shown in adult kidney transplant recipients).
To determine if implementing a genotype-informed Bayesian dosing of tacrolimus is superior to standard weight-based dosing and empiric dose adjustment to trough concentrations post SOT, a combined retrospective/prospective cohort study in Solid Organ Transplant recipients will be undertaken at The Royal Children's Hospital Melbourne.
The outcomes from the Retrospective cohort (over a 5-year period) using clinician-led therapeutic drug monitoring will be compared with the Prospective cohort (n=45), using genotype to predict initial tacrolimus doses and predictive Bayesian dosing for ongoing tacrolimus dosing over a 8-week period.
- Conditions
- Solid Organ Transplant
- Being tested
- Genotyping for CYP3A4 and CYP3A5 genes, Use of NextDose platform, Tacrolimus
- Keywords
- Tacrolimus, Pharmacogenomics, Bayesian, Paediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genotyping for CYP3A4 and CYP3A5 genesDiagnostic test
Genotyping: Patients in the prospective (intervention) arm will undergo genotyping using Illumina's genome-wide genotyping array (Infinium Global Screening Array). Pre-transplant genotyping will test for CYP3A5 *3, *6, *7, *8 and *9 alleles, and will test for CYP3A4*22 only (with CYP3A4*1 reported if no variant corresponding to *22 was present).
The determined diplotypes for CYP3A5 will be matched with predicted phenotypes using the Clinical Pharmacogenetics Implementation Consortium (CPIC®) proposed genotype-to-phenotype translation table. The assignment of the phenotype is outlined in the CPIC guidelines which will used to predict initial dose of tacrolimus. In addition, influence of CYP3A4 will be incorporated based on recent literature and interventional trials. Initial dose in BRUNO-PIC will use allometric size scaling from adult dose, with adjustment based on genotype (CYP3A4 \& CYP3A5)
Use of NextDose platformDevice
NextDose platform is a forecasting tool used to predict tacrolimus dosage. It is a freely available tool and will be used in accordance with guideline. The dosing recommendations will be led by the academic pharmacist in consultation with the PI. This tool will use genotype-informed Bayesian dosing to help predict the time course of tacrolimus concentrations in the body.
TacrolimusDrug
Also called Prograf (Brand)
Tacrolimus is administered to all patients post SOT at The Royal Children's Hospital (RCH)
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort: Pre-emptive CYP3A5/3A4 genotype combined with a Bayesian dose prediction | Experimental | Planned SOT recipients where initial tacrolimus dosing will be based on genotype and subsequent doses predicted using Bayesian revised dosing using NextDose. NextDose, a web-based tool is a model-informed precision dosing software tool used to optimise dosage regimens. It uses Bayesian statistics to integrate prior drug information from a population pharmacokinetic (popPK) model, individual characteristics, and drug concentrations to provide the most accurate individual pharmacokinetic (PK) estimates. The popPK model, a mathematical-statistical model developed from real patient data, captures the drug's typical pharmacokinetics, its variability among individuals and over time, and the factors influencing this variability. By leveraging prior knowledge about a drug's PK along with individual patient data and drug concentrations, the software accurately estimates individual PK parameters with minimal drug concentration data. Tacrolimus dose, form, frequency, \& duration will be assessed Receives: Diagnostic Test: Genotyping for CYP3A4 and CYP3A5 genes; Device: Use of NextDose platform; Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with tacrolimus concentration within the acceptable range (80-125% of concentration target, Cssavg) on post-transplant dosing day 4 (DD4), Week 3 and Week 8
To measure the proportion of cohort with tacrolimus concentration within 80-125% of concentration target on post-transplant dosing day 4 (DD4), week 3 and week 8 - within 80-125% of Cssavg target (where Cssavg is the average steady state concentration).
Measured: Post transplantation at Day 4, Week 3 and week 8
Secondary outcomes (6)
Time taken to reach target tacrolimus concentrations post-transplant.
Median time to acceptable range (80-125% Cssavg) in the immediate post-transplant period.
Measured: Post transplantation through first 8-week period
Time with tacrolimus concentrations within the acceptable range over the first 8 weeks post-transplantation.
Time within acceptable range (80-125% of Cssavg) over the first 8 weeks post-transplant
Measured: Post transplantation through first 8-week period
Proportion of participants with acceptable trough tacrolimus concentrations immediately post-transplant (day 4).
Proportion of tacrolimus concentrations within 80-125% of Csstrough target (steady-state trough concentrations) on DD4
Measured: Post transplantation at Day 4
Number of tacrolimus dose adjustments made over the first 8 weeks post transplant.
Number of dose adjustments of tacrolimus based on therapeutic window approach (TWA) and/or Bayesian.
Measured: Post transplantation at Week 8
Safety of genotype-informed Bayesian dosing within the first 8 weeks post transplant
Safety of genotype-informed Bayesian dosing, including description of number of clinical outcomes: rejection, donor-specific antibody formation; tacrolimus toxicities of new onset diabetes after transplantation.
Measured: From first dose of Tacrolimus through to 8 weeks post transplantation
Feasibility of genotype-informed Bayesian dosing and barriers to implementation.
To record any barriers or challenges that occur in using genotyping and Bayesian dosing for dose prediction of tacrolimus. These can include any technical failures of the NextDose platform for dosing predictions or data access.
Measured: From first dose of Tacrolimus through to 8 weeks post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start5 Aug 2024
- Primary completionAug 2027 (estimated)
- Study completion2 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Organ TransplantStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label trial with a prospective intervention arm and a retrospective standard of care comparator arm. Forty-five SOT recipients will be recruited from The Royal Children's Hospital Melbourne (with retrospective controls taken from the immediately prior 5 years). For all eligible SOT patients, a pre-emptive CYP3A5 and CYP3A4 genotype will be combined with a population PK model to predict optimal initial tacrolimus dose. In addition, genotype-informed Bayesian revised dosing will be applied to all transplant recipients over the subsequent 8-weeks post-transplant. The prospective arm will be compared with a retrospective arm (using standard mg/kg dosing plus therapeutic drug monitoring) where the primary outcome is the proportion of participants in each cohort with tacrolimus concentration (steady-state average concentration) within 80-125% of concentration target (Cssavg) on post-transplant dosing DD4, Week 3 \& Week 8.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Conyers, Principal investigator, Murdoch Childrens Research InstituteDavid Metz, MBBS, PhD, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529536
- Sponsor's protocol ID
- 2023/ETH02699
- Acronym
- BRUNO-PIC
- Status last verified
- Feb 2026
- First submitted
- 26 Jul 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified data set collected for this analysis of this study will be available six months after publication of the primary outcome. The study protocol and analysis plan will also be available. The data must be obtained from the Murdoch Children's Research Institute. Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the Study Management Group must see and approve the data analysis plan describing how the data will be analysed, there must be an agreement around appropriate acknowledgment and any additional costs involved must be covered. Should the Study Management Group be unavailable, this role is delegated to the Murdoch Children's Research Institute. Data will only be shared with a recognized research organisation which has approved the proposed analysis plan.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotype Informed Bayesian Dosing of Tacrolimus in Solid Organ Transplant- Pharmacogenomic Implementation in Children
- ClinicalTrials.gov ID
- NCT06529536
- Acronym / sponsor ID
- BRUNO-PIC / 2023/ETH02699
- Conditions
- Solid Organ Transplant
- Keywords
- Tacrolimus, Pharmacogenomics, Bayesian, Paediatrics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- 2 Aug 2027 (estimated)
- First posted
- 31 Jul 2024 (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.
This study aims to evaluate the efficacy of genotype-informed Bayesian dosing of tacrolimus in optimising drug exposure among paediatric solid organ transplant recipients. By tailoring tacrolimus dosage based on individual genetic makeup and using Bayesian modeling to predict drug levels, the researchers hope to increase the likelihood of achieving therapeutic drug concentrations while minimising the risk of adverse events associated with subtherapeutic or supratherapeutic exposure.
Detailed description
Tacrolimus, a calcineurin inhibitor is an effective immunosuppressant for solid organ transplants (SOT). Due to its narrow therapeutic index and individual variability in its pharmacokinetics (PK), this can lead to inefficacy, toxicities and suboptimal outcomes.
Tacrolimus is typically administered orally twice daily, with a starting dose scaled linearly to body weight (mg/kg). Dose is then adjusted based on measured steady-state trough (pre-dose) whole blood tacrolimus concentrations, to bring to within a desired "therapeutic range". However, this dosing strategy remains associated with incomplete effectiveness and toxicities in a substantial proportion of recipients, related to under- or over-exposure respectively.
Cytochrome P450 CYP3A4 and CYP3A5 enzymes metabolise tacrolimus, with research suggesting a link between genetic variants for these isoenzymes and achievement of tacrolimus target levels. Genotyping for the CYP3A5 \& CYP3A4 gene prior to SOT can identify individuals who are at risk of high or low tacrolimus levels, and guide tacrolimus dosing prior to transplantation. Bayesian prediction is a pharmaco-statistical technique that uses population pharmacokinetic data and individual patient characteristics to accurately predict the tacrolimus dose required to achieve a target concentration. Subtherapeutic levels post-transplant, increases the risk of acute rejection. Furthermore, failure to maintain the target tacrolimus range for the first 6 months significantly raises the chance of rejection, donor-specific antibody formation and graft loss.
Genotype informed dosing algorithms may optimise and ameliorate sub-therapeutic levels, thus potentially reducing the risk of rejection or toxicity, with subsequent Bayesian dosing increasing time within the range of safe and effective concentrations in the subsequent weeks (as shown in adult kidney transplant recipients).
To determine if implementing a genotype-informed Bayesian dosing of tacrolimus is superior to standard weight-based dosing and empiric dose adjustment to trough concentrations post SOT, a combined retrospective/prospective cohort study in Solid Organ Transplant recipients will be undertaken at The Royal Children's Hospital Melbourne.
The outcomes from the Retrospective cohort (over a 5-year period) using clinician-led therapeutic drug monitoring will be compared with the Prospective cohort (n=45), using genotype to predict initial tacrolimus doses and predictive Bayesian dosing for ongoing tacrolimus dosing over a 8-week period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label trial with a prospective intervention arm and a retrospective standard of care comparator arm. Forty-five SOT recipients will be recruited from The Royal Children's Hospital Melbourne (with retrospective controls taken from the immediately prior 5 years). For all eligible SOT patients, a pre-emptive CYP3A5 and CYP3A4 genotype will be combined with a population PK model to predict optimal initial tacrolimus dose. In addition, genotype-informed Bayesian revised dosing will be applied to all transplant recipients over the subsequent 8-weeks post-transplant. The prospective arm will be compared with a retrospective arm (using standard mg/kg dosing plus therapeutic drug monitoring) where the primary outcome is the proportion of participants in each cohort with tacrolimus concentration (steady-state average concentration) within 80-125% of concentration target (Cssavg) on post-transplant dosing DD4, Week 3 \& Week 8.
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort: Pre-emptive CYP3A5/3A4 genotype combined with a Bayesian dose prediction | Experimental | Diagnostic Test: Genotyping for CYP3A4 and CYP3A5 genes, Device: Use of NextDose platform, Drug: TacrolimusPlanned SOT recipients where initial tacrolimus dosing will be based on genotype and subsequent doses predicted using Bayesian revised dosing using NextDose. NextDose, a web-based tool is a model-informed precision dosing software tool used to optimise dosage regimens. It uses Bayesian statistics to integrate prior drug information from a population pharmacokinetic (popPK) model, individual characteristics, and drug concentrations to provide the most accurate individual pharmacokinetic (PK) estimates. The popPK model, a mathematical-statistical model developed from real patient data, captures the drug's typical pharmacokinetics, its variability among individuals and over time, and the factors influencing this variability. By leveraging prior knowledge about a drug's PK along with individual patient data and drug concentrations, the software accurately estimates individual PK parameters with minimal drug concentration data. Tacrolimus dose, form, frequency, \& duration will be assessed |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 1-18 years of age
- Kidney, liver or heart transplant recipients
- Participant and/or parent consent to the study (prospective arm only)
Key exclusion criteria (5 listed)
- Previous liver transplant.
- Lung OR Intestinal transplant.
- Insufficient time before transplant for pharmacogenomic analysis (prospective arm only)
- Immunosuppressant regimen not containing tacrolimus immediate release product
- Known hypersensitivity to tacrolimus and/or its formulation.
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 |
|---|---|---|
| Genotyping for CYP3A4 and CYP3A5 genesGenotyping: Patients in the prospective (intervention) arm will undergo genotyping using Illumina's genome-wide genotyping array (Infinium Global Screening Array). Pre-transplant genotyping will test for CYP3A5 *3, *6, *7, *8 and *9 alleles, and will test for CYP3A4*22 only (with CYP3A4*1 reported if no variant corresponding to *22 was present). The determined diplotypes for CYP3A5 will be matched with predicted phenotypes using the Clinical Pharmacogenetics Implementation Consortium (CPIC®) proposed genotype-to-phenotype translation table. The assignment of the phenotype is outlined in the CPIC guidelines which will used to predict initial dose of tacrolimus. In addition, influence of CYP3A4 will be incorporated based on recent literature and interventional trials. Initial dose in BRUNO-PIC will use allometric size scaling from adult dose, with adjustment based on genotype (CYP3A4 \& CYP3A5) | Diagnostic test | Prospective Cohort: Pre-emptive CYP3A5/3A4 genotype combined with a Bayesian dose prediction |
| Use of NextDose platformNextDose platform is a forecasting tool used to predict tacrolimus dosage. It is a freely available tool and will be used in accordance with guideline. The dosing recommendations will be led by the academic pharmacist in consultation with the PI. This tool will use genotype-informed Bayesian dosing to help predict the time course of tacrolimus concentrations in the body. | Device | Prospective Cohort: Pre-emptive CYP3A5/3A4 genotype combined with a Bayesian dose prediction |
| TacrolimusAlso: Prograf (Brand)Tacrolimus is administered to all patients post SOT at The Royal Children's Hospital (RCH) | Drug | Prospective Cohort: Pre-emptive CYP3A5/3A4 genotype combined with a Bayesian dose prediction |
Primary outcome
Proportion of participants with tacrolimus concentration within the acceptable range (80-125% of concentration target, Cssavg) on post-transplant dosing day 4 (DD4), Week 3 and Week 8
Time frame: Post transplantation at Day 4, Week 3 and week 8
To measure the proportion of cohort with tacrolimus concentration within 80-125% of concentration target on post-transplant dosing day 4 (DD4), week 3 and week 8 - within 80-125% of Cssavg target (where Cssavg is the average steady state concentration).
6 secondary outcomes
Time taken to reach target tacrolimus concentrations post-transplant.
Time frame: Post transplantation through first 8-week period
Time with tacrolimus concentrations within the acceptable range over the first 8 weeks post-transplantation.
Time frame: Post transplantation through first 8-week period
Proportion of participants with acceptable trough tacrolimus concentrations immediately post-transplant (day 4).
Time frame: Post transplantation at Day 4
Number of tacrolimus dose adjustments made over the first 8 weeks post transplant.
Time frame: Post transplantation at Week 8
Safety of genotype-informed Bayesian dosing within the first 8 weeks post transplant
Time frame: From first dose of Tacrolimus through to 8 weeks post transplantation
Feasibility of genotype-informed Bayesian dosing and barriers to implementation.
Time frame: From first dose of Tacrolimus through to 8 weeks post transplantation
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 25 Feb 2026.
- Individual participant dataSharing planned: Yes. The de-identified data set collected for this analysis of this study will be available six months after publication of the primary outcome. The study protocol and analysis plan will also be available. The data must be obtained from the Murdoch Children's Research Institute. Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the Study Management Group must see and approve the data analysis plan describing how the data will be analysed, there must be an agreement around appropriate acknowledgment and any additional costs involved must be covered. Should the Study Management Group be unavailable, this role is delegated to the Murdoch Children's Research Institute. Data will only be shared with a recognized research organisation which has approved the proposed analysis plan.
Related trials for Solid Organ Transplant
Recruiting
Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
Heart Transplant Patients, Kidney Transplant Patients
RecruitingPhase 2
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
Immunization; Infection, Transplantation Infection
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
Active, not recruitingPhase 2
Viral Specific T-cells for Treatment of Viral Infections After Solid Organ Transplant
Solid Organ Transplant, Viral Infection
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
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.
Rachel Conyers principal investigator
Murdoch Childrens Research Institute
David Metz, MBBS, PhD principal investigator
Murdoch Childrens Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Genotyping for CYP3A4 and CYP3A5 genes, Use of NextDose platform and Tacrolimus in people with Solid Organ Transplant, run by Murdoch Childrens Research Institute at 1 site in Australia.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 25 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 Australia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Rachel Conyers (03 9936 6770, pharmaco.genomics@mcri.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with tacrolimus concentration within the acceptable range (80-125% of concentration target, Cssavg) on post-transplant dosing day 4 (DD4), Week 3 and Week 8 (time frame: Post transplantation at Day 4, Week 3 and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2026.