Validation of Population Pharmacokinetic Model Derived From Healthy Volunteer in Kidney Transplant Recipients
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 17, 2016
CompletedFirst Posted
Study publicly available on registry
June 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJune 21, 2016
June 1, 2016
5 months
June 17, 2016
June 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tacrolimus concentration
0, 1, 2, 3, 4 hours post-dose
Secondary Outcomes (1)
Mycophenolate concentration
0, 1, 2, 3, 4 hours post-dose
Study Arms (1)
Tacrolimus + Mycophenolate mofetil
Interventions
Administered dose were individualized according to their own prescription
Administered dose were individualized according to their own prescription
Eligibility Criteria
40 kidney transplant recipients
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yon Su Kim, M.D., Ph.D.
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 17, 2016
First Posted
June 21, 2016
Study Start
May 1, 2016
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
June 21, 2016
Record last verified: 2016-06