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The Pharmacokinetics of Sirolimus When Combined With Cyclosporine or Tacrolimus in Renal Transplant Patients

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ClinicalTrials.gov Identifier: NCT00166816
Recruitment Status : Unknown
Verified July 2001 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 14, 2005
Last Update Posted : September 14, 2005
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to understand the pharmacokinetic of sirolimus in different regimens, as well as the dose-level relationship of cyclosporine and tacrolimus, and design the most appropriate cyclosporine/sirolimus/steroid or tacrolimus/sirolimus/steroid dose regimen for Taiwanese.

Condition or disease Intervention/treatment Phase
Transplantation Kidney Transplantation Immunosuppression Drug: sirolimus, cyclosporine, tacrolimus Phase 4

Detailed Description:

The dose and pharmacokinetic of an immunosuppressant may differ in different ethnics, and different combinations.

The purpose of this study is to determine the dose-level relationship of sirolimus through pharmacokinetic study. The dose-level relationship of cyclosporine and tacrolimus was also assessed. From clinical outcome and blood level of sirolimus and cyclosporine or tacrolimus, we can design the most appropriate cyclosporine/sirolimus/steroid or tacrolimus/sirolimus/steroid dose regimen for Taiwanese.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Pharmacokinetics and Dosage Regimen of Sirolimus in a Cyclosporine or Tacrolimus-Based Immunosuppression in Renal Transplant Patients
Study Start Date : March 2002
Estimated Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetics of sirolimus in different regimens
  2. Dose-concentration relationship of sirolimus

Secondary Outcome Measures :
  1. Efficacy of rejection prevention
  2. Dosage regimen of sirolimus + cyclosporine or tacrolimus
  3. Dose-concentration relationship of cyclosporine/tacrolimus

Eligibility Criteria

Information from the National Library of Medicine

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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 transplantation patients, aged 13-65 years,have 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 multiorgan transplantation, or history of rheumatoid arthritis.
Contacts and Locations

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): NCT00166816

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00166816     History of Changes
Other Study ID Numbers: 900604
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: September 14, 2005
Last Verified: July 2001

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

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antineoplastic Agents