The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus

National Taiwan University

Status and phase: Unknown; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: sirolimus, tacrolimus, mycophenolate mofetil

Study type: Interventional

Funder types: Other

Identifiers

NCT00166829

920606

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 13 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)