NCT00484094

Study Investigating Rapamune For Post-Marketing Surveillance

Post Marketing Surveillance Study To Observe Safety And Efficacy Of Rapamune

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 209 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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

Detailed description

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

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	sirolimus	Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations

Timeline

• Start date: 2011-07-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2007-06-08
• Last updated: 2017-01-16
• Results posted: 2017-01-16

Locations

11 sites across 1 country: South Korea