The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus
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|ClinicalTrials.gov Identifier: NCT00166829|
Recruitment Status : Unknown
Verified August 2003 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : September 14, 2005
Last Update Posted : March 8, 2007
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplantation||Drug: sirolimus, tacrolimus, mycophenolate mofetil||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus|
|Study Start Date :||May 2004|
- The influence of sirolimus on the pharmacokinetics of tacrolimus in renal transplant patients
- Compare the outcome of tacrolimus/sirolimus and tacrolimus/mycophenolate in rejection prevention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00166829
|Contact: Meng-Kun Tsai, MD, PhD||886-2-23123456 ext email@example.com|
|Contact: Fe-Lin L Wu, PhD||886-2-23123456 ext firstname.lastname@example.org|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Meng-Kun Tsai, MD, PhD 886-2-23123456 ext 5622 email@example.com|
|Contact: Fe-Lin L Wu, PhD 886-2-23123456 ext 8389 firstname.lastname@example.org|
|Principal Investigator: Meng-Kun Tsai, MD, PhD|
|Study Chair:||Po-Huang Lee, MD, PhD||National Taiwan University Hospital|