NCT02808065UnknownNot Applicable
Validation of Population Pharmacokinetic Model Derived From Healthy Volunteer in Kidney Transplant Recipients
Seoul National University Hospital1 site in 1 country40 target enrollmentStarted: May 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Tacrolimus concentration
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Low compliance
Arms & Interventions
Tacrolimus + Mycophenolate mofetil
Intervention: Tacrolimus (Drug)
Tacrolimus + Mycophenolate mofetil
Intervention: Mycophenolate mofetil (Drug)
Outcomes
Primary Outcomes
Tacrolimus concentration
Time Frame: 0, 1, 2, 3, 4 hours post-dose
Secondary Outcomes
- Mycophenolate concentration(0, 1, 2, 3, 4 hours post-dose)
Investigators
Yon Su Kim
Principal Investigator
Seoul National University Hospital
Study Sites (1)
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