The Pharmacokinetics of Sirolimus When Combined With Cyclosporine or Tacrolimus in Renal Transplant Patients
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|ClinicalTrials.gov Identifier: NCT00166816|
Recruitment Status : Unknown
Verified July 2001 by National Taiwan University Hospital.
Recruitment status was: Active, not recruiting
First Posted : September 14, 2005
Last Update Posted : September 14, 2005
|Condition or disease||Intervention/treatment||Phase|
|Transplantation Kidney Transplantation Immunosuppression||Drug: sirolimus, cyclosporine, tacrolimus||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Pharmacokinetics and Dosage Regimen of Sirolimus in a Cyclosporine or Tacrolimus-Based Immunosuppression in Renal Transplant Patients|
|Study Start Date :||March 2002|
|Estimated Study Completion Date :||June 2003|
- Pharmacokinetics of sirolimus in different regimens
- Dose-concentration relationship of sirolimus
- Efficacy of rejection prevention
- Dosage regimen of sirolimus + cyclosporine or tacrolimus
- Dose-concentration relationship of cyclosporine/tacrolimus
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): NCT00166816
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Study Chair:||Po-Huang Lee||National Taiwan University Hospital|