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

June 17, 2016 updated by: Yon Su Kim, Seoul National University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

40 kidney transplant recipients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tacrolimus + Mycophenolate mofetil
Drug: Tacrolimus
Administered dose were individualized according to their own prescription
Other Names:
  • Prograf
Drug: Mycophenolate mofetil
Administered dose were individualized according to their own prescription
Other Names:
  • Cellcept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tacrolimus concentration
Time Frame: 0, 1, 2, 3, 4 hours post-dose
0, 1, 2, 3, 4 hours post-dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Mycophenolate concentration
Time Frame: 0, 1, 2, 3, 4 hours post-dose
0, 1, 2, 3, 4 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ministry of Food and Drug Safety, Korea

Investigators

  • Principal Investigator: Yon Su Kim, M.D., Ph.D., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

June 17, 2016

First Submitted That Met QC Criteria

June 17, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 17, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-2016-001-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Transplantation

Clinical Trials on Tacrolimus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe