Study Investigating Rapamune for Post-Marketing Surveillance

This study is not yet open for participant recruitment.

Verified by Wyeth, June 2007

First Received: June 7, 2007 Last Updated: June 15, 2007 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00484094

Purpose

To provide safety and effectiveness information for Rapamune during the post-marketing period as required by KFDA regulations in order to identify any potential drug related treatment factors in the Korean population, such as:

Unknown adverse reactions, especially serious adverse reactions
To assess the incidence of adverse reactions under the routine drug uses
Factors that may affect the safety of the drug (e.g. proteinurea)
Factors that may affect the effectiveness of the drug

Condition	Intervention	Phase
Renal Transplant	Drug: Rapamune (Sirolimus)	Phase IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Sirolimus

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Case Control, Prospective Study
Official Title:	A Post-Marketing Surveillance (PMS) Study of the Safety and Effectiveness of Rapamune Therapy in Korean Renal Transplant Patients

Further study details as provided by Wyeth:

Estimated Enrollment:	600
Study Start Date:	June 2007
Estimated Study Completion Date:	March 2012

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Any new patient given at lease one (1) dose of Rapamune per registered indications, as stated in the product label/insert.

Exclusion Criteria:

Patients to whom Rapamune is contraindicated, as per the local labeling; Patient whith known hypersensitivity to Rapamune or any component of the product.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484094

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	0468X1-4411
Study First Received:	June 7, 2007
Last Updated:	June 15, 2007
ClinicalTrials.gov Identifier:	NCT00484094 History of Changes
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Sirolimus
Anti-Bacterial Agents
Immunologic Factors
Clotrimazole

Miconazole
Antifungal Agents
Tioconazole
Immunosuppressive Agents

Additional relevant MeSH terms:

Sirolimus
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 May 07, 2009