Text Size

Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2002 by National Taiwan University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00166842
First received: September 12, 2005
Last updated: NA
Last verified: July 2002
History: No changes posted
  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 4

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:

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:

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 May 21, 2013