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Computer Guided Doing of Tacrolimus in Renal Transplantation

NCT ID: NCT02010320

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-07-31

Brief Summary

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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

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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

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Renal Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Computer dosed

Patients for which the computer model will calculate the individual doses

Group Type EXPERIMENTAL

Computer dosing

Intervention Type OTHER

Pharmacokinetic population model for individual dose estimations of tacrolimus based on concentrations measurements and inclusion of relevant covariates

Control

Patients which will get their tacrolimus doses determined by experience transplant physicians

Group Type ACTIVE_COMPARATOR

Standard dose determination

Intervention Type OTHER

Tacrolimus dose determination according to trough concentrations and standard TDM at the clinic

Interventions

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Computer dosing

Pharmacokinetic population model for individual dose estimations of tacrolimus based on concentrations measurements and inclusion of relevant covariates

Intervention Type OTHER

Standard dose determination

Tacrolimus dose determination according to trough concentrations and standard TDM at the clinic

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* renal transplant recipients using tacrolimus as part of their immunosuppression
* above 18 years
* signed informed consent

Exclusion Criteria

* no specific
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rikshospitalet University Hospital

OTHER

Sponsor Role collaborator

University of Oslo School of Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anders Åsberg, PhD

Role: STUDY_CHAIR

OUS-Rikshospitalet and University of Oslo

Locations

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Olso university hospital - Rikshospitalet

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 25886918 (View on PubMed)

Other Identifiers

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OPTIMAL-13

Identifier Type: -

Identifier Source: org_study_id