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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 29, 2014