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

• Status: Unknown status
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Ministry of Food and Drug Safety, Korea
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

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