Validation of Population Pharmacokinetic Model Derived From Healthy Volunteer in Kidney Transplant Recipients

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

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-10-31

Brief Summary

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Pharmacokinetic model to predict interaction between tacrolimus and mycophenolate was developed through clinical trial with healthy volunteer. The purpose of this study is to confirm predictability of developed pharmacokinetic model in kidney transplant recipients.

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Detailed Description

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Study participants take their immunosuppressant as usual. One day, blood is drawn at predose and 1, 2, 3, 4-hour postdose to compare observed concentration with model-predicted concentration of tacrolimus and mycophenolate.

Conditions

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Kidney Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tacrolimus + Mycophenolate mofetil

Tacrolimus

Intervention Type DRUG

Administered dose were individualized according to their own prescription

Mycophenolate mofetil

Intervention Type DRUG

Administered dose were individualized according to their own prescription

Interventions

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Tacrolimus

Administered dose were individualized according to their own prescription

Intervention Type DRUG

Mycophenolate mofetil

Administered dose were individualized according to their own prescription

Intervention Type DRUG

Other Intervention Names

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Prograf Cellcept

Eligibility Criteria

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Inclusion Criteria

* Age of 18 years or older
* At least 6 months after kidney transplantation
* Were on tacrolimus alone or tacrolimus plus mycophenolate based immunosuppressive regimen
* Maintained stable dose of immunosuppressants for at least two weeks

Exclusion Criteria

* AST or ALT \>3 upper limit of normal range
* Had gastrointestinal disorder that may affect an absorption of drug
* Coadministration of drugs that may affect the pharmacokinetics of immunosuppressive drug
* Multi-organ transplant recipient
* Severe psychiatric disorder
* Drug or alcohol abuser
* Pregnant
* Low compliance

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No