- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00166829
The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus
Study Overview
Status
Conditions
Intervention / Treatment
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 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
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Meng-Kun Tsai, MD, PhD
- Phone Number: 5622 886-2-23123456
- Email: mark9@ha.mc.ntu.edu.tw
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Contact:
- Fe-Lin L Wu, PhD
- Phone Number: 8389 886-2-23123456
- Email: flwu@ha.mc.ntu.edu.tw
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Principal Investigator:
- Meng-Kun Tsai, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- De novo kidney transplant patients
- Aged 13 - 65 years
- Having aminotransferase concentrations within 2 times the upper limit of normal
Exclusion Criteria:
- Pregnancy
- Tuberculosis
- Hepatitis B or C carrier status
- Human immunodeficiency virus-positive status
- Retransplantation or multi-organ transplantation
- History of rheumatoid arthritis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The influence of sirolimus on the pharmacokinetics of tacrolimus in renal transplant patients
|
Secondary Outcome Measures
Outcome Measure |
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Compare the outcome of tacrolimus/sirolimus and tacrolimus/mycophenolate in rejection prevention
|
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
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Antitubercular Agents
- Antibiotics, Antitubercular
- Calcineurin Inhibitors
- Tacrolimus
- Mycophenolic Acid
- Sirolimus
Other Study ID Numbers
- 920606
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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