NCT00166842

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

September 14, 2005

Status Verified

July 1, 2002

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

TransplantationKidney TransplantationImmunosuppression

Keywords

PharmacokineticsSirolimusCyclosporineTacrolimusImmunosuppressive AgentsImmunosuppressionTransplantationKidney Transplantation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Effectiveness of different sirolimus dose regimens in rejection prevention

Interventions

sirolimus, cyclosporine, tacrolimusDRUG

Eligibility Criteria

Age13 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ages of 18 and 65, renal transplant patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 15660173RESULT

MeSH Terms

Interventions

SirolimusCyclosporineTacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Po-Huang Lee, MD PhD

    National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

September 1, 2002

Last Updated

September 14, 2005

Record last verified: 2002-07

Locations

TW(1)