PharmacokineticsMISSIONNCT06095895
Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment
An observational study of Pharmacokinetics and Area Under Curve, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
This is a prospective observational study of MIPD in clinical practice for paediatric kidney transplant patients using tacrolimus and mycophenolic acid in Radboudumc. Dose individualization in paediatric kidney transplant patients using the InsightRX platform is performed as standard care, meaning that a… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Pharmacokinetics, Area Under Curve, Tacrolimus
- What is being tested?
- venipuncture
- How many people
- 29 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Mar 2024to 20 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Paediatric kidney transplant patients from Radboudumc using tacrolimus and/or mycophenolic acid. We will collect data for one year, in this period we expect to include 30 patients.
Who may be able to join
- Kidney transplant patients using tacrolimus and/or mycophenolic acid
- Age between 0 and 18 years
- Indication for an AUC measurement - judgement of clinician
Who cannot join
- Incapacitated patients
- No informed consent
- Not proficient in the Dutch language
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective observational study of MIPD in clinical practice for paediatric kidney transplant patients using tacrolimus and mycophenolic acid in Radboudumc. Dose individualization in paediatric kidney transplant patients using the InsightRX platform is performed as standard care, meaning that a pharmacokinetic model and drug levels measured at t=0, t=1 and t=2 hours will be used to calculate the exposure. Based on the estimated exposure, the pharmacist gives a dose recommendation to the physician, who can then modify the dosage of mycophenolic acid or tacrolimus. The selected dose and the measured MPA and tacrolimus concentrations will be used to predict the future exposure. A second exposure measurement will be performed to evaluate whether our model is able to predict future exposure.
- Conditions
- Pharmacokinetics, Area Under Curve, Tacrolimus, Immunosuppressive Agents, Mycophenolic Acid
- Being tested
- venipuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venipunctureOther
An additional measurement of exposure of mycophenolic acid and/or tacrolimus will be performed
What is being measured
The primary outcome is the main question the study is designed to answer.
Bias
Mean prediction error
Measured: 1 year
Precision
Root mean squared error
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start15 Mar 2024
- Primary completion15 Nov 2024
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nynke Jager, Dr, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095895
- Sponsor's protocol ID
- NL85390.091.23
- Acronym
- MISSION
- Status last verified
- Nov 2025
- First submitted
- 16 Oct 2023
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heida A, Cornelissen EAM, Aarnoutse RE, de Winter BCM, Keizer RJ, Ter Heine R, Jager NGL. Structured Evaluation of Model-Informed Precision Dosing of Mycophenolic Acid and Tacrolimus in Pediatric Patients with Kidney Disease. Clin Pharmacokinet. 2026 Sep 30. doi: 10.1007/s40262-026-01708-3. Online ahead of print.
PubMed 42814375
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment
- ClinicalTrials.gov ID
- NCT06095895
- Acronym / sponsor ID
- MISSION / NL85390.091.23
- Conditions
- Pharmacokinetics, Area Under Curve, Tacrolimus, Immunosuppressive Agents, Mycophenolic Acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 23 Oct 2023 (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 is a prospective observational study of MIPD in clinical practice for paediatric kidney transplant patients using tacrolimus and mycophenolic acid in Radboudumc. Dose individualization in paediatric kidney transplant patients using the InsightRX platform is performed as standard care, meaning that a pharmacokinetic model and drug levels measured at t=0, t=1 and t=2 hours will be used to calculate the exposure. Based on the estimated exposure, the pharmacist gives a dose recommendation to the physician, who can then modify the dosage of mycophenolic acid or tacrolimus. The selected dose and the measured MPA and tacrolimus concentrations will be used to predict the future exposure. A second exposure measurement will be performed to evaluate whether our model is able to predict future exposure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Paediatric kidney transplant patients from Radboudumc using tacrolimus and/or mycophenolic acid. We will collect data for one year, in this period we expect to include 30 patients.
Key inclusion criteria (3 listed)
- Kidney transplant patients using tacrolimus and/or mycophenolic acid
- Age between 0 and 18 years
- Indication for an AUC measurement - judgement of clinician
Key exclusion criteria (3 listed)
- Incapacitated patients
- No informed consent
- Not proficient in the Dutch language
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 |
|---|---|---|
| venipunctureAn additional measurement of exposure of mycophenolic acid and/or tacrolimus will be performed | Other | – |
Primary outcome
Bias
Time frame: 1 year
Mean prediction error
Precision
Time frame: 1 year
Root mean squared error
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Derived from this study: PubMed 42814375Heida A, Cornelissen EAM, Aarnoutse RE, de Winter BCM, Keizer RJ, Ter Heine R, Jager NGL. Structured Evaluation of Model-Informed Precision Dosing of Mycophenolic Acid and Tacrolimus in Pediatric Patients with Kidney Disease. Clin Pharmacokinet. 2026 Sep 30. doi: 10.1007/s40262-026-01708-3. Online ahead of print.
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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. This study is not recruiting at the moment.
Nynke Jager, Dr principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacokinetics and Area Under Curve, run by Radboud University Medical Center at 1 site in Netherlands.
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 3 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: finished, as of the sponsor's last update on 2 Dec 2025. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bias (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT06095895, which also lists 1 linked publication.
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 2 Dec 2025.