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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

September 12, 2005
September 12, 2005
September 2002
Not Provided
  • 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.
Same as current
No Changes Posted
Effectiveness of different sirolimus dose regimens in rejection prevention
Same as current
Not Provided
Not Provided
 
Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets
Effects of Conversion From Sirolimus Oral Solution to Tablets in Renal Transplant Recipients.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Transplantation
  • Kidney Transplantation
  • Immunosuppression
Drug: sirolimus, cyclosporine, tacrolimus
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
Not Provided
Not Provided

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
Both
13 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00166842
910506, NTUH S92
Not Provided
Not Provided
National Taiwan University Hospital
Not Provided
Study Chair: Po-Huang Lee, MD PhD National Taiwan University Hospital
National Taiwan University Hospital
July 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP