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Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets

NCT ID: NCT00166842

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

2002-09-30

Brief Summary

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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

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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.

Conditions

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Transplantation Kidney Transplantation Immunosuppression

Keywords

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Pharmacokinetics Sirolimus Cyclosporine Tacrolimus Immunosuppressive Agents Immunosuppression Transplantation Kidney 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

* 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
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, MD PhD

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, Sun SW, Chen RR, Huang JD, Lee PH. Effects of conversion from sirolimus oral solution to tablets in stable Taiwanese renal transplant recipients. J Formos Med Assoc. 2005 Jan;104(1):22-8.

Reference Type RESULT
PMID: 15660173 (View on PubMed)

Other Identifiers

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NTUH S92

Identifier Type: -

Identifier Source: secondary_id

910506

Identifier Type: -

Identifier Source: org_study_id