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NCT00166829 Clinical Trial

The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus

Kidney Transplantation Clinical Trial

Official title:
The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00166829
Other study ID # 920606
Secondary ID
Status Recruiting
Phase Phase 4
First received September 12, 2005
Last updated March 7, 2007
Start date May 2004

Study information
Verified date August 2003
Source National Taiwan University Hospital
Contact Meng-Kun Tsai, MD, PhD
Phone 886-2-23123456
Email mark9@ha.mc.ntu.edu.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 65 Years
Eligibility Inclusion Criteria:

- De novo kidney transplant patients

- Aged 13 - 65 years

- Having aminotransferase concentrations within 2 times the upper limit of normal

Exclusion Criteria:

- Pregnancy

- Tuberculosis

- Hepatitis B or C carrier status

- Human immunodeficiency virus-positive status

- Retransplantation or multi-organ transplantation

- History of rheumatoid arthritis

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• sirolimus, tacrolimus, mycophenolate mofetil

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The influence of sirolimus on the pharmacokinetics of tacrolimus in renal transplant patients
Secondary Compare the outcome of tacrolimus/sirolimus and tacrolimus/mycophenolate in rejection prevention
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