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Sponsored by: |
National Taiwan University Hospital |
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Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00166816 |
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.
Condition | Intervention | Phase |
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Transplantation Kidney Transplantation Immunosuppression |
Drug: sirolimus, cyclosporine, tacrolimus |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | The Pharmacokinetics and Dosage Regimen of Sirolimus in a Cyclosporine or Tacrolimus-Based Immunosuppression in Renal Transplant Patients |
Estimated Enrollment: | 40 |
Study Start Date: | March 2002 |
Estimated Study Completion Date: | June 2003 |
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.
Ages Eligible for Study: | 13 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 900604, NTUH S010 |
Study First Received: | September 12, 2005 |
Last Updated: | September 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00166816 History of Changes |
Health Authority: | Taiwan: Department of Health |
Sirolimus Tacrolimus Cyclosporine Pharmacokinetics |
Immunosuppressive Agents Immunosuppression Kidney Transplantation Transplantation |
Sirolimus Anti-Bacterial Agents Cyclosporine Immunologic Factors Clotrimazole Miconazole |
Antifungal Agents Tioconazole Tacrolimus Antirheumatic Agents Immunosuppressive Agents Cyclosporins |
Sirolimus Anti-Infective Agents Cyclosporine Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Tacrolimus |
Antibiotics, Antineoplastic Cyclosporins Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Antifungal Agents Therapeutic Uses Antirheumatic Agents Dermatologic Agents |