CClinicalTrials.gg
Status unknownNCT00166829Updated Mar 8, 2007

The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus

A Phase 4 interventional study of sirolimus, tacrolimus, mycophenolate mofetil in Kidney Transplantation, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 13 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-03-08.

Sponsored by National Taiwan University Hospital · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2003), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
13 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed description

The controlled clinical trial held in NTUH in 2001 revealed that the bioavailability of tacrolimus when combined with sirolimus is lower than that reported in the literature where tacrolimus was not combined with sirolimus. To determine if the difference was due to the drug interaction between sirolimus and tacrolimus, a controlled clinical trial was proposed.

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

02

Conditions studied

  • Kidney Transplantation

Keywords

  • Tacrolimus
  • Sirolimus
  • Mycophenolic acid
  • Immunosuppressive Agents
  • Immunosuppression
  • Kidney Transplantation
  • Transplantation
03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • De novo kidney transplant patients
  • Aged 13 - 65 years
  • Having aminotransferase concentrations within 2 times the upper limit of normal

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Tuberculosis
  • Hepatitis B or C carrier status
  • Human immunodeficiency virus-positive status
  • Retransplantation or multi-organ transplantation
  • History of rheumatoid arthritis
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants

Interventions

  • Drugsirolimus, tacrolimus, mycophenolate mofetil
06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
    Recruiting
08

References and documents

Publications

  • 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. PubMed 19670189 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00166829
Lead sponsor
National Taiwan University Hospital
First posted
Sep 14, 2005
Start date
May 2004
Last update
Mar 8, 2007

Study contacts

Meng-Kun Tsai, MD, PhD
Contact
mark9@ha.mc.ntu.edu.tw
886-2-23123456 ext. 5622
Fe-Lin L Wu, PhD
Contact
flwu@ha.mc.ntu.edu.tw
886-2-23123456 ext. 8389
Po-Huang Lee, MD, PhD
study chair · National Taiwan University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2003. You cannot join it, but the record below documents what was studied.

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