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Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets

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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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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