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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02808065
• Other study ID #: 17-2016-001-5
• Status: Recruiting
• Phase: N/A
• First received: June 17, 2016
• Last updated: June 17, 2016
• Start date: May 2016
• Est. completion date: October 2016

Study information

• Verified date: June 2016
• Source: Seoul National University Hospital
• Contact: Jae Hyun Kim
• Phone: 82-2-2072-0335
• Email: jaerung90[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Tacrolimus
Administered dose were individualized according to their own prescription
• Mycophenolate mofetil
Administered dose were individualized according to their own prescription

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ministry of Food and Drug Safety, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tacrolimus concentration		0, 1, 2, 3, 4 hours post-dose	No
Secondary	Mycophenolate concentration		0, 1, 2, 3, 4 hours post-dose	No