Pharmacokinetic of Everolimus and Atorvastatin Co-administration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-01-31

Brief Summary

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Hypothesis : In renal transplantation recipient who received immunosuppressive drug "certican" and have hypercholesterolemia will get lipid lower drug-HMG Co-A reductase inhibitors. Because atorvastatin and everolimus have metabolism via Cytochrome P450 subfamily 3A4 both, so investigator made the hypothesis that when patients received everolimus with atorvastatin will change area under the time concentration curve of everolimus.

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Detailed Description

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Population : Thai postrenal transplantation recipient who received everolimus and have hypercholesterolemia in posttransplantation clinic at Faculty of Medicine, Chulalongkorn University.

Study Design : Experimental study, Two-sample crossover study Sample size calculation :N = 18 Primary outcome : 12-hour area under the time concentration curve of everolimus Secondary outcome : renal function (serum creatinine, creatinine clearance)

Method :

1. Patients will random to everolimus or everolimus with atorvastatin 20 mg arm for 1 month.
2. Take blood sample for everolimus concentration at time 0,0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 hour
3. After first blood sample, patients will received everolimus only for 1 month (wash out period)
4. Patients will switch to another arm eg.patient who had received everolimus will switch to everolimus with atorvastatin 20 mg for 1 month
5. Take blood sample for everolimus concentration at time 0,0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 hour
6. Everolimus level will analyse for 12-hour AUC of everolimus.

Conditions

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Difference of 12-hour AUC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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everolimus

Everolimus administration with adjusted dose to target C trough (C0) level between 3-12 ng/mL

Group Type PLACEBO_COMPARATOR

Atorvastatin 20 mg

Intervention Type DRUG

Add atorvastatin 20 mg and compare 12-hour AUC of everolimus between Arm everolimus and everolimus with atorvastatin 20 mg

everolimus with atorvastatin 20 mg

Co-administration of everolimus and atorvastatin. Everolimus administration with adjusted dose to target C trough (C0)level between 3-12 ng/mL.

Atorvastatin 20 mg/day (fixed dose)

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

Administration only everolimus, no atorvastatin. Everolimus administration with adjusted dose to target C trough (C0)level between 3-12 ng/mL.

Interventions

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Atorvastatin 20 mg

Add atorvastatin 20 mg and compare 12-hour AUC of everolimus between Arm everolimus and everolimus with atorvastatin 20 mg

Intervention Type DRUG

Everolimus

Administration only everolimus, no atorvastatin. Everolimus administration with adjusted dose to target C trough (C0)level between 3-12 ng/mL.

Intervention Type DRUG

Other Intervention Names

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Lipitor 20 mg Everolimus alone

Eligibility Criteria

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Inclusion Criteria

* Post renal transplantation recipient who received immunosuppressive drug Everolimus and has hypercholesterolemia
* Co everolimus level within 3-12 ng/mL
* Informed consent
* Patient can follow research methodology