NCT00166829

Brief Summary

The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.4 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

March 8, 2007

Status Verified

August 1, 2003

First QC Date

September 12, 2005

Last Update Submit

March 7, 2007

Conditions

Kidney Transplantation

Keywords

TacrolimusSirolimusMycophenolic acidImmunosuppressive AgentsImmunosuppressionKidney TransplantationTransplantation

Outcome Measures

Primary Outcomes (1)

  • The influence of sirolimus on the pharmacokinetics of tacrolimus in renal transplant patients

Secondary Outcomes (1)

  • Compare the outcome of tacrolimus/sirolimus and tacrolimus/mycophenolate in rejection prevention

Interventions

sirolimus, tacrolimus, mycophenolate mofetilDRUG

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 transplant patients
  • Aged 13 - 65 years
  • Having 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 multi-organ transplantation
  • History of rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

  • 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

SirolimusTacrolimusMycophenolic Acid

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • Po-Huang Lee, MD, PhD

    National Taiwan University Hospital

    STUDY CHAIR

Central Study Contacts

Meng-Kun Tsai, MD, PhD

CONTACT

886-2-23123456mark9@ha.mc.ntu.edu.tw

Fe-Lin L Wu, PhD

CONTACT

886-2-23123456flwu@ha.mc.ntu.edu.tw

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

May 1, 2004

Last Updated

March 8, 2007

Record last verified: 2003-08

Locations

TW(1)