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The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2003 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00166829
First received: September 12, 2005
Last updated: March 7, 2007
Last verified: August 2003
History of Changes
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   13 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166829

Contacts
Contact: Meng-Kun Tsai, MD, PhD 886-2-23123456 ext 5622 mark9@ha.mc.ntu.edu.tw
Contact: Fe-Lin L Wu, PhD 886-2-23123456 ext 8389 flwu@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Meng-Kun Tsai, MD, PhD     886-2-23123456 ext 5622     mark9@ha.mc.ntu.edu.tw    
Contact: Fe-Lin L Wu, PhD     886-2-23123456 ext 8389     flwu@ha.mc.ntu.edu.tw    
Principal Investigator: Meng-Kun Tsai, MD, PhD            
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Po-Huang Lee, MD, PhD National Taiwan University Hospital
  More Information

No publications provided by National Taiwan University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00166829     History of Changes
Other Study ID Numbers: 920606
Study First Received: September 12, 2005
Last Updated: March 7, 2007
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Immunosuppressive Agents
Mycophenolate mofetil
Sirolimus
Everolimus
Tacrolimus
Mycophenolic Acid
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013