Study Investigating Rapamune For Post-Marketing Surveillance

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

1. Unknown adverse reactions, especially serious adverse reactions

2. To assess the incidence of adverse reactions under the routine drug uses

3. Factors that may affect the safety of the drug (e.g., proteinuria)

4. Factors that may affect the effectiveness of the drug

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• Subjects aged 13 years or older receiving renal transplants, who are newly administered Rapamune after a contract is made between Pfizer Korea and an investigator and/or an institution for conducting this study.

Exclusion Criteria:

• Any patient who does not agree that Pfizer and companies working with Pfizer use his/her information.

• Patients who have known hypersensitivity to Rapamune or its derivatives or any excipients in the formulation.