Status:
UNKNOWN
Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Transplantation
Kidney Transplantation
Eligibility:
All Genders
13-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to understand the pharmacokinetics of sirolimus tablets in different regimens in newly renal transplant patients, and the effect of dosage form conversion on the concentra...
Detailed Description
Sirolimus tablets will be available more than one year after the launch of sirolimus solution. Most patients on sirolimus solution will use sirolimus tablet instead. The purpose of this study is to u...
Eligibility Criteria
Inclusion
- ages of 18 and 65, renal transplant patients
Exclusion
- pregnancy, tuberculosis, hepatitis B or C carrier status, human immunodeficiency virus-positive status, retransplantation or multiorgan transplantation, or history of rheumatoid arthritis before transplantation
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00166842
Start Date
September 1 2002
Last Update
September 14 2005
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100