Validation of Population Pharmacokinetic Model Derived From Healthy Volunteer in Kidney Transplant Recipients
- Conditions
- Kidney Transplantation
- Interventions
- Registration Number
- NCT02808065
- Lead Sponsor
- Seoul National University Hospital
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tacrolimus + Mycophenolate mofetil Tacrolimus - Tacrolimus + Mycophenolate mofetil Mycophenolate mofetil -
- Primary Outcome Measures
Name Time Method Tacrolimus concentration 0, 1, 2, 3, 4 hours post-dose
- Secondary Outcome Measures
Name Time Method Mycophenolate concentration 0, 1, 2, 3, 4 hours post-dose
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of