At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Rapamune
In Brief
An observational study evaluating sirolimus for Kidney Transplantation. Completed, enrolled 209 participants across 11 sites.
Detailed 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
Study Details
Timeline
Interventions
Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations