Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients
The Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients, and the Effect of ABCB1、CYP3A4、CYP3A5、PORGenetic Polymorphism on the Two Drugs
1 other identifier
interventional
14
1 country
1
Brief Summary
The purpose of this study is to understand the effects of everolimus on tacrolimus pharmacokinetics (pk) in patients receiving de novo kidney transplants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2014
Longer than P75 for phase_4
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
First Submitted
Initial submission to the registry
March 2, 2014
CompletedFirst Posted
Study publicly available on registry
March 4, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2019
CompletedJuly 24, 2019
July 1, 2018
4.8 years
March 2, 2014
July 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic profiles
Pharmacokinetic parameters include the maximum concentration, trough concentration, area under the whole-blood concentration-time curve between 0 and 12 hours, time to maximum concentration, volume of distribution at steady state, and clearance at steady state.
Post-operation day 8-10
Secondary Outcomes (1)
Acute rejection
Within the first 2 weeks post-transplantation
Study Arms (2)
Everolimus
EXPERIMENTALEverolimus/Tacrolimus/Methylprednisolone \& Prednisolone
Mycophenolate mofetil
ACTIVE COMPARATORMycophenolate mofetil/Tacrolimus/ Methylprednisolone \& Prednisolone
Interventions
Everolimus: 1 mg orally every 12 hours from post-operation day 1 to achieve trough concentrations of 3-8 ng/mL
Mycophenolate mofetil: 10-15 mg/kg orally every 12 hours from post-operation day 1 (decrease 50% dose if white blood cell \< 4000/mcL)
Tacrolimus: 0.05-0.075 mg/kg orally every 12 hours from post-operation day 1 to achieve trough concentrations of 8-12 ng/mL
Methylprednisolone: 50 mg iv every 6 hours on post-operation day 1, 40 mg iv every 6 hours on post-operation day 2, 30 mg iv every 6 hours on post-operation day 3, 20 mg iv every 6 hours on post-operation day 4, 20 mg iv every 8 hours on post-operation day 5, 20 mg iv every 12 hours on post-operation day 6, 20 mg iv on post-operation day 7
Prednisolone: 20 mg orally once a day from post-operation day 8 to post-operation week 4, then titrated gradually
Eligibility Criteria
You may qualify if:
- De novo kidney transplants
- years old
- aspartate aminotransferase/alanine aminotransferase within 2 times the upper limit of normal range
You may not qualify if:
- Pregnancy
- Tuberculosis
- Hepatitis B or C carrier status
- Human immunodeficiency virus-positive status
- Retransplantation or multiorgan transplantation
- History of rheumatoid arthritis
- Use of drugs that might have enhanced or inhibited CYP3A4 or P-gp activity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meng-Kun Tsai
National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2014
First Posted
March 4, 2014
Study Start
April 1, 2014
Primary Completion
January 15, 2019
Study Completion
January 15, 2019
Last Updated
July 24, 2019
Record last verified: 2018-07