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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
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Renal transplant recipients need life long immunosuppression and one of the new drugs is everolimus. Everolimus is a potent immunosuppressive drug and one of the main side-effects are increased blood cholesterol levels. Many renal transplant recipients are treated with a cholesterol lowering agent, mainly fluvastatin. Rosuvastatin is a new cholesterol lowering drug on the market with a potential higher cholesterol lowering potency. In the present study the investigators will examine the hypothesis that rosuvastatin reduce cholesterol levels more than fluvastatin in renal transplant patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin | Experimental | Rosuvastatin treatment for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | 20 mg rosuvastatin for 4 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| compare the treatment efficacy (blood lipid lowering effect) of rosuvastatin versus fluvastatin | Compare the blood lipid levels before and after switch from fluvastatin to rosuvastatin | 4 weeks |
| Area Under Curve (AUC) of rosuvastatin in renal transplant recipients treated with everolimus. Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post dose. | Compare 24-h pharmacokinetics of renal transplant recipients with historic controls | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Area Under Curve (AUC) of everolimus during rosuvastatin versus fluvastatin therapy, including intracellular everolimus concentrations within T-lymphocytes. Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours post-dose. | 4 weeks | |
| 2. Investigate P-gp activity in whole blood in everolimus treated patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Ã…sberg, PhD | University of Oslo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital, Rikshospitalet | Oslo | 0027 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24521776 | Derived | Robertsen I, Asberg A, Granseth T, Vethe NT, Akhlaghi F, Ghareeb M, Molden E, Reier-Nilsen M, Holdaas H, Midtvedt K. More potent lipid-lowering effect by rosuvastatin compared with fluvastatin in everolimus-treated renal transplant recipients. Transplantation. 2014 Jun 27;97(12):1266-71. doi: 10.1097/01.TP.0000443225.66960.7e. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| 4 weeks |
| 3. Study inter individual variation in rosuvastatin and everolimus pharmacokinetics in renal transplant recipients due to polymorphism in the genes encoding P-gp, OATP1B1 and CYP3A5 | 4 weeks |
| 4. Compare effect of rosuvastatin versus fluvastatin therapy on the renal function (eGFR) | 4 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |