The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus - Full Text View

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00166829

Purpose

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

Condition	Intervention	Phase
Kidney Transplantation	Drug: sirolimus, tacrolimus, mycophenolate mofetil	Phase IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Sirolimus Tacrolimus anhydrous Mycophenolic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	May 2004

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.

Eligibility

Ages Eligible for Study:	13 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166829

Contacts

Contact: Meng-Kun Tsai, MD, PhD	886-2-23123456 ext 5622	mark9@ha.mc.ntu.edu.tw
Contact: Fe-Lin L Wu, PhD	886-2-23123456 ext 8389	flwu@ha.mc.ntu.edu.tw

Locations

Taiwan
National Taiwan University Hospital	Recruiting
Taipei, Taiwan, 100
Contact: Meng-Kun Tsai, MD, PhD 886-2-23123456 ext 5622 mark9@ha.mc.ntu.edu.tw
Contact: Fe-Lin L Wu, PhD 886-2-23123456 ext 8389 flwu@ha.mc.ntu.edu.tw
Principal Investigator: Meng-Kun Tsai, MD, PhD

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Study Chair:

Po-Huang Lee, MD, PhD

National Taiwan University Hospital

More Information

Study ID Numbers:	920606
Study First Received:	September 12, 2005
Last Updated:	March 7, 2007
ClinicalTrials.gov Identifier:	NCT00166829
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

Tacrolimus
Sirolimus
Mycophenolic acid
Immunosuppressive Agents

Immunosuppression
Kidney Transplantation
Transplantation

Study placed in the following topic categories:

Sirolimus
Clotrimazole
Miconazole
Tioconazole

Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Antifungal Agents

Therapeutic Uses
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009