Renal TransplantationPhase 4OPTIMALNCT02010320
Computer Guided Doing of Tacrolimus in Renal Transplantation
A Phase 4 study testing Computer dosing and Standard dose determination in people with Renal Transplantation, run by University of Oslo School of Pharmacy at 1 site in Norway.
Trial summary
Dosing of tacrolimus is challenging due to the large inter-individual variation in its pharmacokinetics. The investigators have developed a pharmacokinetics population model that can be used to estimate individual doses of tacrolimus in renal transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Computer dosing and Standard dose determination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2014to Jul 2014
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- renal transplant recipients using tacrolimus as part of their immunosuppression
- above 18 years
- signed informed consent
Who cannot join
- no specific
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Testing of Pharmacokinetic Population Models for Dosing of Transplanted Patients
Dosing of tacrolimus is challenging due to the large inter-individual variation in its pharmacokinetics. The investigators have developed a pharmacokinetics population model that can be used to estimate individual doses of tacrolimus in renal transplant recipients. The model will be prospective tested in a randomized clinical trial.
The hypothesis is that the computer model is superior to experienced transplant physicians in reaching and keeping the patients in the target range of tacrolimus.
Read the detailed description
Patients will be randomized to either computer or standard dosing strategies at time of transplantation or as early after transplantation as possible in case of deceased donor transplants.
For patients in the computer arm the model will calculate the dose with the highest probability to reach the specified concentration target.
For all concentrations a predictive error will be calculated and this will be the primary endpoint that the statistics will be calculated on.
All patients will be followed for between 8 to 12 weeks post-transplant, according to center praxis.
- Conditions
- Renal Transplantation
- Being tested
- Computer dosing, Standard dose determination
- Keywords
- population model, pharmacokinetic, tacrolimus, therapeutic drug monitoring, individualized dosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer dosingOther
Pharmacokinetic population model for individual dose estimations of tacrolimus based on concentrations measurements and inclusion of relevant covariates
Standard dose determinationOther
Tacrolimus dose determination according to trough concentrations and standard TDM at the clinic
| Study group | Role | What they receive |
|---|---|---|
| Computer dosed | Experimental | Patients for which the computer model will calculate the individual doses Receives: Other: Computer dosing |
| Control | Active comparator | Patients which will get their tacrolimus doses determined by experience transplant physicians Receives: Other: Standard dose determination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive error (Cpred-Cobs)
Predictive error will be calculated as the computer predicted concentration minus the measured concentration over the first 8 to 12 weeks post-transplant in the computer group. The calculations will be binned into weekly assessments.
Measured: 8 to 12 weeks
Reaching the target concentration
In each arm the deviation of the observed concentration front he preset target concentration will be calculated for each measured concentration. The deviations will be compared between the two arms.
Measured: 8 to 12 weeks post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionJul 2014
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 Renal TransplantationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo School of Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Rikshospitalet University Hospital
- Responsible party
- Sponsor
- Investigators
- Anders Åsberg, PhD, Study chair, OUS-Rikshospitalet and University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010320
- Sponsor's protocol ID
- OPTIMAL-13
- Acronym
- OPTIMAL
- Status last verified
- Dec 2014
- First submitted
- 9 Dec 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Storset E, Asberg A, Skauby M, Neely M, Bergan S, Bremer S, Midtvedt K. Improved Tacrolimus Target Concentration Achievement Using Computerized Dosing in Renal Transplant Recipients--A Prospective, Randomized Study. Transplantation. 2015 Oct;99(10):2158-66. doi: 10.1097/TP.0000000000000708.
PubMed 25886918
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Testing of Pharmacokinetic Population Models for Dosing of Transplanted Patients
- ClinicalTrials.gov ID
- NCT02010320
- Acronym / sponsor ID
- OPTIMAL / OPTIMAL-13
- Conditions
- Renal Transplantation
- Keywords
- population model, pharmacokinetic, tacrolimus, therapeutic drug monitoring, individualized dosing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Oslo School of PharmacyUniversity, hospital or other
- Collaborators
- Rikshospitalet University Hospital
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 12 Dec 2013 (estimated)
- 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.
Dosing of tacrolimus is challenging due to the large inter-individual variation in its pharmacokinetics. The investigators have developed a pharmacokinetics population model that can be used to estimate individual doses of tacrolimus in renal transplant recipients. The model will be prospective tested in a randomized clinical trial.
The hypothesis is that the computer model is superior to experienced transplant physicians in reaching and keeping the patients in the target range of tacrolimus.
Detailed description
Patients will be randomized to either computer or standard dosing strategies at time of transplantation or as early after transplantation as possible in case of deceased donor transplants.
For patients in the computer arm the model will calculate the dose with the highest probability to reach the specified concentration target.
For all concentrations a predictive error will be calculated and this will be the primary endpoint that the statistics will be calculated on.
All patients will be followed for between 8 to 12 weeks post-transplant, according to center praxis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer dosed | Experimental | Other: Computer dosingPatients for which the computer model will calculate the individual doses |
| Control | Active comparator | Other: Standard dose determinationPatients which will get their tacrolimus doses determined by experience transplant physicians |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- renal transplant recipients using tacrolimus as part of their immunosuppression
- above 18 years
- signed informed consent
Key exclusion criteria (1 listed)
- no specific
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 |
|---|---|---|
| Computer dosingPharmacokinetic population model for individual dose estimations of tacrolimus based on concentrations measurements and inclusion of relevant covariates | Other | Computer dosed |
| Standard dose determinationTacrolimus dose determination according to trough concentrations and standard TDM at the clinic | Other | Control |
Primary outcome
Predictive error (Cpred-Cobs)
Time frame: 8 to 12 weeks
Predictive error will be calculated as the computer predicted concentration minus the measured concentration over the first 8 to 12 weeks post-transplant in the computer group. The calculations will be binned into weekly assessments.
Reaching the target concentration
Time frame: 8 to 12 weeks post-transplant
In each arm the deviation of the observed concentration front he preset target concentration will be calculated for each measured concentration. The deviations will be compared between the two arms.
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 3 Dec 2014.
- Derived from this study: PubMed 25886918Storset E, Asberg A, Skauby M, Neely M, Bergan S, Bremer S, Midtvedt K. Improved Tacrolimus Target Concentration Achievement Using Computerized Dosing in Renal Transplant Recipients--A Prospective, Randomized Study. Transplantation. 2015 Oct;99(10):2158-66. doi: 10.1097/TP.0000000000000708.
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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.
Anders Åsberg, PhD study chair
OUS-Rikshospitalet and University of Oslo
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 Computer dosing and Standard dose determination in people with Renal Transplantation, run by University of Oslo School of Pharmacy at 1 site in Norway.
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 1 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 3 Dec 2014. 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 Norway. 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?
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?
Predictive error (Cpred-Cobs) (time frame: 8 to 12 weeks). 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 NCT02010320, 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 3 Dec 2014.