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Study Investigating Rapamune For Post-Marketing Surveillance

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: June 7, 2007
Last updated: October 23, 2015
Last verified: October 2015

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

Condition Intervention
Kidney Transplantation
Drug: sirolimus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Rapamune

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Adverse events: Incidence, severity, and seriousness, outcome and causality of adverse events and discontinuation due to adverse events will be monitored. [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    adverse events occurred in usual practice

  • Clinically significant abnormal finding from laboratory test (if any) [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence rate of biopsy-confirmed acute rejection using Banff 09 diagnostic categories for renal allograft biopsies [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    BCAR (biopsy confirmed acute rejection)

  • Graft function: estimated glomerular filtration rate (eGFR) calculated using Nankivell formula [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Subject survival [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Graft survival [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Enrollment: 209
Study Start Date: July 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rapamune Drug: sirolimus
Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations
Other Name: Rapamune

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

Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who receive Rapamune after kidney transplantation

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00484094

Korea, Republic of
Yeungnam University Medical Center
Daegu, Korea, Republic of, 705-717
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Gyeonggi-do, Korea, Republic of, 480-717
Maryknoll Medical Center
Pusan, Korea, Republic of, 600-730
Seoul National University Hospital (SNUH)
Seoul, Korea, Republic of, 110-744
Kangdong Sacred Heart Hospital
Seoul, Korea, Republic of, 134-814
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 135-720
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT00484094     History of Changes
Other Study ID Numbers: 0468X1-4411  B1741015 
Study First Received: June 7, 2007
Last Updated: October 23, 2015
Health Authority: Korea: Ministry of Food and Drug Safety
Korea: Food and Drug Administration

Keywords provided by Pfizer:
Kidney Transplantation

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on December 02, 2016