Post Marketing Surveillance Study To Observe Safety And Efficacy Of Rapamune
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 209
- Locations
- 11
- Primary Endpoint
- Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs
Study Overview
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:
- 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
All patients who receive Rapamune for certain period of time should be included as far as patients consent to participate
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Rapamune
Intervention: sirolimus (Drug)
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
Time Frame: 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
Time Frame: 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 Outcomes
- 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.)
- 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.)
- 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.)
- 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.)