- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00166842
Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets
Effects of Conversion From Sirolimus Oral Solution to Tablets in Renal Transplant Recipients.
Study Overview
Status
Intervention / Treatment
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 understand the pharmacokinetics of sirolimus tablets in different regimens in newly renal transplant patients, and the effect of dosage form conversion on the concentration of sirolimus in stable renal transplant patients. So that we can design a better tacrolimus or cyclosporine/sirolimus/steroid dose regimen for Taiwanese.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ages of 18 and 65, renal transplant patients
Exclusion Criteria:
- pregnancy, tuberculosis, hepatitis B or C carrier status, human immunodeficiency virus-positive status, retransplantation or multiorgan transplantation, or history of rheumatoid arthritis before transplantation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Pharmacokinetics of sirolimus tablets in different regimens in de novo renal transplant patients
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Effect of dosage form conversion on sirolimus concentration in stable renal transplant patients.
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Secondary Outcome Measures
Outcome Measure |
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Effectiveness of different sirolimus dose regimens in rejection prevention
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Collaborators and Investigators
Investigators
- Study Chair: Po-Huang Lee, MD PhD, National Taiwan University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Calcineurin Inhibitors
- Tacrolimus
- Sirolimus
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- 910506
- NTUH S92
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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