ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00166829
Recruitment Status : Unknown
Verified August 2003 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 14, 2005
Last Update Posted : March 8, 2007
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief Summary:
The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: sirolimus, tacrolimus, mycophenolate mofetil Phase 4

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 : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus
Study Start Date : May 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00166829     History of Changes
Other Study ID Numbers: 920606
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: March 8, 2007
Last Verified: August 2003

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

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