Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets

Kidney Transplantation Clinical Trial

Official title:

Effects of Conversion From Sirolimus Oral Solution to Tablets in Renal Transplant Recipients.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00166842
• Other study ID #: 910506
• Secondary ID: NTUH S92
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: September 2002

Study information

• Verified date: July 2002
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Immunosuppression
• Kidney Transplantation
• Transplantation

Intervention

Drug:
• sirolimus, cyclosporine, tacrolimus

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of sirolimus tablets in different regimens in de novo renal transplant patients
Primary	Effect of dosage form conversion on sirolimus concentration in stable renal transplant patients.
Secondary	Effectiveness of different sirolimus dose regimens in rejection prevention