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

Seoul National University

Status: Unknown

Conditions: Kidney Transplantation

Treatments: Drug: Mycophenolate mofetil; Drug: Tacrolimus

Study type: Observational

Funder types: Other

Identifiers

NCT02808065

17-2016-001-5

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Tacrolimus + Mycophenolate mofetil

Treatment:

Drug: Tacrolimus

Drug: Mycophenolate mofetil