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OPTImization of the Dose of tacroliMUS by Bayesian Prediction

NCT03465410 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2021-01-08

No results posted yet for this study

Summary

The pharmacokinetics of tacrolimus (TAC) are characterized by high inter- and intra-individual variability with narrow therapeutic range. Currently, the limiting point of Tac drug monitoring is the inability to individualize doses during the first few days after transplantation. Our group developed a population pharmacokinetic model (PPK) identifying CYP3A4 \* 22 and CYP3A5 \* 3 polymorphisms and hematocrit as explanatory variables of the observed variability in pre-dose (Co) concentrations. According to this model, the proportion of patients that do not reach the therapeutic target is 40

Conditions

  • KIDNEY TRANSPLANTATION

Interventions

DRUG

Standard dosage of Tacrolimus

Immediate release Tacrolimus (Prograf/Adoport)

DRUG

Bayesian Prediction Tacrolimus dosage

Immediate release Tacrolimus (Prograf/Adoport)

Sponsors & Collaborators

  • NURIA LLOBERAS BLANCH

    lead OTHER

Principal Investigators

  • Núria Lloberas, PhD · Hospital Universitari de Bellvitge

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-21
Primary Completion
2020-09-21
Completion
2020-09-21

Countries

  • Spain

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 NCT03465410 on ClinicalTrials.gov