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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2001 by National Taiwan University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00166816
First received: September 12, 2005
Last updated: NA
Last verified: July 2001
History: No changes posted
  Purpose

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 Intervention Phase
Transplantation
Kidney Transplantation
Immunosuppression
 Drug: sirolimus, cyclosporine, tacrolimus
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Pharmacokinetics of sirolimus in different regimens
  • Dose-concentration relationship of sirolimus

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

Estimated Enrollment: 40
Study Start Date: March 2002
Estimated Study Completion Date: June 2003
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.

  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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166816

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

Publications:

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

ClinicalTrials.gov Identifier: NCT00166816     History of Changes
Other Study ID Numbers: 900604, NTUH S010
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Sirolimus
Tacrolimus
Cyclosporine
Pharmacokinetics
 Immunosuppressive Agents
Immunosuppression
Kidney Transplantation
Transplantation

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

ClinicalTrials.gov processed this record on May 23, 2013