Study Investigating Rapamune For Post-Marketing Surveillance

Pfizer

Status: Completed

Conditions: Kidney Transplantation

Treatments: Drug: sirolimus

Study type: Observational

Funder types: Industry

Identifiers

NCT00484094

0468X1-4411

B1741015 (Other Identifier)

Details and patient eligibility

About

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

Full description

All patients who receive Rapamune for certain period of time should be included as far as patients consent to participate

Enrollment: 209 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

209 participants in 1 patient group

Rapamune

Treatment:

Drug: sirolimus