Status:
UNKNOWN
The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Kidney Transplantation
Eligibility:
All Genders
13-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.
Detailed Description
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 c...
Eligibility Criteria
Inclusion
- De novo kidney transplant patients
- Aged 13 - 65 years
- Having aminotransferase concentrations within 2 times the upper limit of normal
Exclusion
- Pregnancy
- Tuberculosis
- Hepatitis B or C carrier status
- Human immunodeficiency virus-positive status
- Retransplantation or multi-organ transplantation
- History of rheumatoid arthritis
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00166829
Start Date
May 1 2004
Last Update
March 8 2007
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100