Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets - Full Text View

Sponsor:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00166842

Purpose

The purpose of this study is to understand the pharmacokinetics of sirolimus tablets in different regimens in newly renal transplant patients, and the effect of dosage form conversion on the concentration of sirolimus in stable renal transplant patients. So that we can design a better tacrolimus or cyclosporine/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 Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Effects of Conversion From Sirolimus Oral Solution to Tablets in Renal Transplant Recipients.

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 tablets in different regimens in de novo renal transplant patients
Effect of dosage form conversion on sirolimus concentration in stable renal transplant patients.

Secondary Outcome Measures:

Effectiveness of different sirolimus dose regimens in rejection prevention

Estimated Enrollment:	40
Study Start Date:	September 2002

Detailed Description:

Sirolimus tablets will be available more than one year after the launch of sirolimus solution. Most patients on sirolimus solution will use sirolimus tablet instead.

The purpose of this study is to understand the pharmacokinetics of sirolimus tablets in different regimens in newly renal transplant patients, and the effect of dosage form conversion on the concentration of sirolimus in stable renal transplant patients. So that we can design a better tacrolimus or cyclosporine/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:

ages of 18 and 65, renal transplant patients

Exclusion Criteria:

pregnancy, tuberculosis, hepatitis B or C carrier status, human immunodeficiency virus－positive status, retransplantation or multiorgan transplantation, or history of rheumatoid arthritis before transplantation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166842

Locations

Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Study Chair:

Po-Huang Lee, MD PhD

National Taiwan University Hospital

More Information

Publications:

Wu FL, Tsai MK, Sun SW, Chen RR, Huang JD, Lee PH. Effects of conversion from sirolimus oral solution to tablets in stable Taiwanese renal transplant recipients. J Formos Med Assoc. 2005 Jan;104(1):22-8.

ClinicalTrials.gov Identifier:	NCT00166842 History of Changes
Other Study ID Numbers:	910506, NTUH S92
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

Pharmacokinetics
Sirolimus
Cyclosporine
Tacrolimus

Immunosuppressive Agents
Immunosuppression
Transplantation
Kidney 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