Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets

National Taiwan University

Status and phase: Unknown; Phase 4

Conditions: Kidney Transplantation; Immunosuppression; Transplantation

Treatments: Drug: sirolimus, cyclosporine, tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT00166842

910506

NTUH S92

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 13 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)