Study Investigating Rapamune For Post-Marketing Surveillance

Pfizer209 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

209

Conditions

Kidney Transplantation

Interventions

sirolimusDRUG

Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations

Eligibility

Sex: ALLMin age: 13 Years

Medical Language ↔ Plain English

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.

Locations (11)

Seoul National University Hospital (SNUH)

Seoul, Seoul, South Korea

Yeungnam University Medical Center

Daegu, South Korea

The Catholic University of Korea Uijeongbu St. Mary's Hospital

Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.

Secondary Outcomes

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.

Time frame: 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.

Time frame: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.

Data from ClinicalTrials.gov

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