NCT00166816

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2002

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
2.3 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, 2001

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

TransplantationKidney TransplantationImmunosuppression

Keywords

SirolimusTacrolimusCyclosporinePharmacokineticsImmunosuppressive AgentsImmunosuppressionKidney TransplantationTransplantation

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics of sirolimus in different regimens

  • Dose-concentration relationship of sirolimus

Secondary Outcomes (3)

  • Efficacy of rejection prevention

  • Dosage regimen of sirolimus + cyclosporine or tacrolimus

  • Dose-concentration relationship of cyclosporine/tacrolimus

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:

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

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (2)

  • 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.

    PMID: 15899725RESULT

  • 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.

    PMID: 19670189DERIVED

MeSH Terms

Interventions

SirolimusCyclosporineTacrolimus

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Po-Huang Lee

    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

March 1, 2002

Study Completion

June 1, 2003

Last Updated

September 14, 2005

Record last verified: 2001-07

Locations

TW(1)