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Sponsored by: |
National Taiwan University Hospital |
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Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00166829 |
The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.
Condition | Intervention | Phase |
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Kidney Transplantation |
Drug: sirolimus, tacrolimus, mycophenolate mofetil |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study |
Official Title: | The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus |
Estimated Enrollment: | 40 |
Study Start Date: | May 2004 |
The controlled clinical trial held in NTUH in 2001 revealed that the bioavailability of tacrolimus when combined with sirolimus is lower than that reported in the literature where tacrolimus was not combined with sirolimus. To determine if the difference was due to the drug interaction between sirolimus and tacrolimus, a controlled clinical trial was proposed.
The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.
Ages Eligible for Study: | 13 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Meng-Kun Tsai, MD, PhD | 886-2-23123456 ext 5622 | mark9@ha.mc.ntu.edu.tw |
Contact: Fe-Lin L Wu, PhD | 886-2-23123456 ext 8389 | flwu@ha.mc.ntu.edu.tw |
Taiwan | |
National Taiwan University Hospital | Recruiting |
Taipei, Taiwan, 100 | |
Contact: Meng-Kun Tsai, MD, PhD 886-2-23123456 ext 5622 mark9@ha.mc.ntu.edu.tw | |
Contact: Fe-Lin L Wu, PhD 886-2-23123456 ext 8389 flwu@ha.mc.ntu.edu.tw | |
Principal Investigator: Meng-Kun Tsai, MD, PhD |
Study Chair: | Po-Huang Lee, MD, PhD | National Taiwan University Hospital |
Study ID Numbers: | 920606 |
Study First Received: | September 12, 2005 |
Last Updated: | March 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00166829 |
Health Authority: | Taiwan: Department of Health |
Tacrolimus Sirolimus Mycophenolic acid Immunosuppressive Agents |
Immunosuppression Kidney Transplantation Transplantation |
Sirolimus Clotrimazole Miconazole Tioconazole |
Mycophenolate mofetil Mycophenolic Acid Tacrolimus |
Anti-Bacterial Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Antifungal Agents |
Therapeutic Uses Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |