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The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2003 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Information provided by:
National Taiwan University Hospital Identifier:
First received: September 12, 2005
Last updated: March 7, 2007
Last verified: August 2003
The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.

Condition Intervention Phase
Kidney Transplantation
Drug: sirolimus, tacrolimus, mycophenolate mofetil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The influence of sirolimus on the pharmacokinetics of tacrolimus in renal transplant patients

Secondary Outcome Measures:
  • Compare the outcome of tacrolimus/sirolimus and tacrolimus/mycophenolate in rejection prevention

Estimated Enrollment: 40
Study Start Date: May 2004
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.


Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00166829

National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Study Chair: Po-Huang Lee, MD, PhD National Taiwan University Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00166829     History of Changes
Other Study ID Numbers: 920606 
Study First Received: September 12, 2005
Last Updated: March 7, 2007

Keywords provided by National Taiwan University Hospital:
Mycophenolic acid
Immunosuppressive Agents
Kidney Transplantation

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents processed this record on February 20, 2017