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Computer Guided Doing of Tacrolimus in Renal Transplantation

NCT02010320 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-12-03

No results posted yet for this study

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. 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.

Conditions

  • Renal Transplantation

Interventions

OTHER

Computer dosing

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

OTHER

Standard dose determination

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

Sponsors & Collaborators

  • Rikshospitalet University Hospital

    collaborator OTHER

  • University of Oslo School of Pharmacy

    lead OTHER

Principal Investigators

  • Anders Åsberg, PhD · OUS-Rikshospitalet and University of Oslo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02010320 on ClinicalTrials.gov