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| ID | Type | Description | Link |
|---|---|---|---|
| NTUH S010 |
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The purpose of this study is to understand the pharmacokinetic of sirolimus in different regimens, as well as the dose-level relationship of cyclosporine and tacrolimus, and design the most appropriate cyclosporine/sirolimus/steroid or tacrolimus/sirolimus/steroid dose regimen for Taiwanese.
The dose and pharmacokinetic of an immunosuppressant may differ in different ethnics, and different combinations.
The purpose of this study is to determine the dose-level relationship of sirolimus through pharmacokinetic study. The dose-level relationship of cyclosporine and tacrolimus was also assessed. From clinical outcome and blood level of sirolimus and cyclosporine or tacrolimus, we can design the most appropriate cyclosporine/sirolimus/steroid or tacrolimus/sirolimus/steroid dose regimen for Taiwanese.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sirolimus, cyclosporine, tacrolimus | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of sirolimus in different regimens | ||
| Dose-concentration relationship of sirolimus |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of rejection prevention | ||
| Dosage regimen of sirolimus + cyclosporine or tacrolimus | ||
| Dose-concentration relationship of cyclosporine/tacrolimus |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Po-Huang Lee | National Taiwan University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15899725 | Result | Wu FL, Tsai MK, Chen RR, Sun SW, Huang JD, Hu RH, Chen KH, Lee PH. Effects of calcineurin inhibitors on sirolimus pharmacokinetics during staggered administration in renal transplant recipients. Pharmacotherapy. 2005 May;25(5):646-53. doi: 10.1592/phco.25.5.646.63593. | |
| 19670189 | Derived | Tsai MK, Wu FL, Lai IR, Lee CY, Hu RH, Lee PH. Decreased acute rejection and improved renal allograft survival using sirolimus and low-dose calcineurin inhibitors without induction therapy. Int J Artif Organs. 2009 Jun;32(6):371-80. doi: 10.1177/039139880903200608. |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D016572 | Cyclosporine |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D003524 | Cyclosporins |
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| D010456 |
| Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |