The Pharmacokinetics of Sirolimus When Combined With Cyclosporine or Tacrolimus in Renal Transplant Patients

The Pharmacokinetics and Dosage Regimen of Sirolimus in a Cyclosporine or Tacrolimus-Based Immunosuppression in Renal Transplant Patients

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00166816

Enrollment

Registered

2005-09-14

Start date

2002-03-31

Completion date

2003-06-30

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

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

Brief summary

The purpose of this study is to understand the pharmacokinetic of sirolimus in different regimens, as well as the dose-level relationship of cyclosporine and tacrolimus, and design the most appropriate cyclosporine/sirolimus/steroid or tacrolimus/sirolimus/steroid dose regimen for Taiwanese.

Detailed description

The dose and pharmacokinetic of an immunosuppressant may differ in different ethnics, and different combinations. The purpose of this study is to determine the dose-level relationship of sirolimus through pharmacokinetic study. The dose-level relationship of cyclosporine and tacrolimus was also assessed. From clinical outcome and blood level of sirolimus and cyclosporine or tacrolimus, we can design the most appropriate cyclosporine/sirolimus/steroid or tacrolimus/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

* De novo kidney transplantation patients, aged 13-65 years,have aminotransferase concentrations within 2 times the upper limit of normal.

Exclusion criteria

* pregnancy, tuberculosis, hepatitis B or C carrier status, human immunodeficiency virus-positive status, retransplantation or multiorgan transplantation, or history of rheumatoid arthritis.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of sirolimus in different regimens	—
Dose-concentration relationship of sirolimus	—

Secondary

Measure	Time frame
Efficacy of rejection prevention	—
Dosage regimen of sirolimus + cyclosporine or tacrolimus	—
Dose-concentration relationship of cyclosporine/tacrolimus	—

Countries

Taiwan

Outcome results

None listed

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