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| Name | Class |
|---|---|
| Ratchadapiseksompotch Research Fund | UNKNOWN |
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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.
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| everolimus | Placebo Comparator | Everolimus administration with adjusted dose to target C trough (C0) level between 3-12 ng/mL |
|
| everolimus with atorvastatin 20 mg | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 20 mg | Drug | Add atorvastatin 20 mg and compare 12-hour AUC of everolimus between Arm everolimus and everolimus with atorvastatin 20 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 12-hour area under the time concentration curve of everolimus | compare when taking only everolimus to coadministered with atorvastatin | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function | Renal function : serum creatinine, 24 hour creatinine clearance 24 hour urine protein, Urinalysis Sample take at month 0,1,2,3 | 3 months |
| Liver function test | Total protein, Albumin, total bilirubin, direct bilirubin, AST, ALT, Alkaline phosphatase at month 0,1,2,3 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of 12-hour AUC and point of everolimus level | To correlate between 12-hour AUC and point of everolimus level | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anocha Wanitchanont, MD. | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Chulalongkorn Memorial Hospital | Bangkok | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11831546 | Background | Kovarik JM, Hartmann S, Hubert M, Berthier S, Schneider W, Rosenkranz B, Rordorf C. Pharmacokinetic and pharmacodynamic assessments of HMG-CoA reductase inhibitors when coadministered with everolimus. J Clin Pharmacol. 2002 Feb;42(2):222-8. doi: 10.1177/00912700222011148. |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Everolimus | Drug | Administration only everolimus, no atorvastatin. Everolimus administration with adjusted dose to target C trough (C0)level between 3-12 ng/mL. |
|
|
| 3 month |
| Lipid profile | Total cholesterol, Triglyceride, HDL, LDL at month 0,1,2,3 | 3 month |
| Rhabdomyolysis | Adverse drug reaction from atorvastatin by measured CPK at month 0,1,2,3 | 3 month |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |