Kidney Transplantation Clinical Trial
Official title:
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Rapamune
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
Status | Completed |
Enrollment | 209 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 13 Years and older |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | 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 | Asan Medical Center | Seoul | |
Korea, Republic of | Gangnam Severance Hospital, Yonsei University Health System | Seoul | |
Korea, Republic of | Kangdong Sacred Heart Hospital | Seoul | |
Korea, Republic of | Konkuk University Medical Center | Seoul | |
Korea, Republic of | Korea University Anam Hospital | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital (SNUH) | Seoul | |
Korea, Republic of | The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events: Incidence, severity, and seriousness, outcome and causality of adverse events and discontinuation due to adverse events will be monitored. | adverse events occurred in usual practice | 6 month | Yes |
Primary | Clinically significant abnormal finding from laboratory test (if any) | 6 month | Yes | |
Secondary | Incidence rate of biopsy-confirmed acute rejection using Banff 09 diagnostic categories for renal allograft biopsies | BCAR (biopsy confirmed acute rejection) | 6 month | No |
Secondary | Graft function: estimated glomerular filtration rate (eGFR) calculated using Nankivell formula | 6 month | No | |
Secondary | Subject survival | 6 month | No | |
Secondary | Graft survival | 6 month | No |
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