Study Investigating Rapamune For Post-Marketing Surveillance

Completed

Brief 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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Rapamune	sirolimus	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs	Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.	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.
Percentage of Participants With Clinically Significent Abnormal Laboratory Test	Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.	Laboratory test was not mandatory because this study was a non-interventional study.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies	At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.	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.
Percentage of Participants Alive	At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.	The investigator recorded the participant's survival status and evaluation date on the CRF.
Percentage of Participants With Survived Graft	At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.	Graft survival was defined as not showing graft loss at the time of evaluation.
Estimated Glomerular Filtration Rate (eGFR) Calculated by Nankivell Formula	At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.	Graft function was evaluated by eGFR using Nankivell formula. The investigator recorded the date of evaluation and the calculated value on the CRF.

Locations (11): Yeungnam University Medical Center
🇰🇷
Daegu, Korea, Republic of
The Catholic University of Korea Uijeongbu St. Mary's Hospital
🇰🇷
Gyeonggi-do, Korea, Republic of
Maryknoll Medical Center
🇰🇷
Pusan, Korea, Republic of
Seoul National University Hospital (SNUH)
🇰🇷
Seoul, Korea, Republic of
Kangdong Sacred Heart Hospital
🇰🇷
Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷
Seoul, Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System
🇰🇷
Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷
Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷
Seoul, Korea, Republic of
Asan Medical Center
🇰🇷
Seoul, Korea, Republic of
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Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of