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

NCT ID: NCT00166816

Last Updated: 2005-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2003-06-30

Brief Summary

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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

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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.

Conditions

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Transplantation Kidney Transplantation Immunosuppression

Keywords

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Sirolimus Tacrolimus Cyclosporine Pharmacokinetics Immunosuppressive Agents Immunosuppression Kidney Transplantation Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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sirolimus, cyclosporine, tacrolimus

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Po-Huang Lee

Role: STUDY_CHAIR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Wu FL, Tsai MK, Chen RR, Sun SW, Huang JD, Hu RH, Chen KH, Lee PH. Effects of calcineurin inhibitors on sirolimus pharmacokinetics during staggered administration in renal transplant recipients. Pharmacotherapy. 2005 May;25(5):646-53. doi: 10.1592/phco.25.5.646.63593.

Reference Type RESULT
PMID: 15899725 (View on PubMed)

Tsai MK, Wu FL, Lai IR, Lee CY, Hu RH, Lee PH. Decreased acute rejection and improved renal allograft survival using sirolimus and low-dose calcineurin inhibitors without induction therapy. Int J Artif Organs. 2009 Jun;32(6):371-80. doi: 10.1177/039139880903200608.

Reference Type DERIVED
PMID: 19670189 (View on PubMed)

Other Identifiers

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NTUH S010

Identifier Type: -

Identifier Source: secondary_id

900604

Identifier Type: -

Identifier Source: org_study_id