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Status unknownNCT00166842Updated Sep 14, 2005

Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets

A Phase 4 interventional study of sirolimus, cyclosporine, tacrolimus in Transplantation, Kidney Transplantation and Immunosuppression, 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 2005-09-14.

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

The sponsor has not verified this record recently (last verified Jul 2002), so the status shown — last known as Active, not recruiting — may be out of date.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 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.

Read the detailed description

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.

02

Conditions studied

  • Transplantation
  • Kidney Transplantation
  • Immunosuppression

Keywords

  • Pharmacokinetics
  • Sirolimus
  • Cyclosporine
  • Tacrolimus
  • Immunosuppressive Agents
  • Immunosuppression
  • Transplantation
  • Kidney Transplantation
03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 568 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) 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

  • ages of 18 and 65, renal transplant patients

Exclusion criteria

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
05

Study design

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

Interventions

  • Drugsirolimus, cyclosporine, tacrolimus
06

What researchers measure

Primary outcomes

  1. Pharmacokinetics of sirolimus tablets in different regimens in de novo renal transplant patients

  2. 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

07

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
08

References and documents

Publications

  • 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. PubMed 15660173 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00166842
Lead sponsor
National Taiwan University Hospital
First posted
Sep 14, 2005
Start date
Sep 2002
Last update
Sep 14, 2005

Study contacts

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 Jul 2002. You cannot join it, but the record below documents what was studied.

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