Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00166842

Enrollment

Registered

2005-09-14

Start date

2002-09-30

Completion date

Unknown

Last updated

2005-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunosuppression, Kidney Transplantation, Transplantation

Keywords

Pharmacokinetics, Sirolimus, Cyclosporine, Tacrolimus, Immunosuppressive Agents, Immunosuppression, Transplantation, Kidney Transplantation

Brief 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.

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.

Interventions

DRUGsirolimus, cyclosporine, tacrolimus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Effectiveness of different sirolimus dose regimens in rejection prevention	—

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026