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Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2002 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00166842
First Posted: September 14, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

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
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
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): 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
First Submitted: September 12, 2005
First Posted: September 14, 2005
Last Update Posted: December 9, 2005
Last Verified: July 2002

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

Additional relevant MeSH terms:
Tacrolimus
Cyclosporins
Cyclosporine
Sirolimus
Everolimus
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