Pharmacokinetic of Everolimus and Atorvastatin Co-administration

Chulalongkorn University

Status: Completed

Conditions: Difference of 12-hour AUC

Treatments: Drug: Everolimus; Drug: Atorvastatin 20 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01780948

A7478

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Patient don't want to participate in the study
• Post renal transplantation recipient who have normal lipid profile

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups, including a placebo group

everolimus

Placebo Comparator group

Description:

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

Treatment:

Drug: Atorvastatin 20 mg

everolimus with atorvastatin 20 mg

Experimental group

Description:

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)

Treatment:

Drug: Everolimus