Study Investigating Rapamune For Post-Marketing Surveillance

Study Overview
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Brief Summary
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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: 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., proteinuria) Factors that may affect the effectiveness of the drug

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

Official Title
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Post Marketing Surveillance Study To Observe Safety And Efficacy Of Rapamune

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: sirolimus


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rapamune<br> | Drug: sirolimus<br>* Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations<br>* Other names: Rapamune;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs | All AEs reported after the start of administration of Rapamune were considered as treatment-emergent AEs and summarized. All AEs, except for those with causal relationship to the study drug assessed as unlikely, were considered as AEs whose causal relationship to the study drug could not be excluded and classified as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer. | Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier. | 
| Percentage of Participants With Clinically Significent Abnormal Laboratory Test | Laboratory test was not mandatory because this study was a non-interventional study. | Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies | Renal biopsy was required to confirm the diagnosis of acute rejection. However, due to the non-interventional nature of this study, biopsy could not be mandatory. The decision of whether to perform a biopsy was made at the discretion of the investigator and the result was collected if performed. | At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier. | 
| Percentage of Participants Alive | The investigator recorded the participant's survival status and evaluation date on the CRF. | At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier. | 
| Percentage of Participants With Survived Graft | Graft survival was defined as not showing graft loss at the time of evaluation. | At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier. | 
| Estimated Glomerular Filtration Rate (eGFR) Calculated by Nankivell Formula | Graft function was evaluated by eGFR using Nankivell formula. The investigator recorded the date of evaluation and the calculated value on the CRF. | At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rapamune, Safety, Efficacy, Kidney Transplantation