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

First Received on September 12, 2005. No Changes Posted

Sponsor:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00166816

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 IV

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:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Sirolimus Cyclosporine Cyclosporin Tacrolimus anhydrous Tacrolimus Everolimus CCI 779

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:

Wu FL, Tsai MK, Chen RR, Sun SW, Huang JD, Hu RH, Chen KH, Lee PH. Effects of calcineurin inhibitors on sirolimus pharmacokinetics during staggered administration in renal transplant recipients. Pharmacotherapy. 2005 May;25(5):646-53.

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

Tsai MK, Wu FL, Lai IR, Lee CY, Hu RH, Lee PH. Decreased acute rejection and improved renal allograft survival using sirolimus and low-dose calcineurin inhibitors without induction therapy. Int J Artif Organs. 2009 Jun;32(6):371-80.

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 February 09, 2012