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Study Investigating Rapamune For Post-Marketing Surveillance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00484094
First received: June 7, 2007
Last updated: November 21, 2016
Last verified: November 2016
  Purpose

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:
  • 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 Outcome Measures:
  • Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


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
  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00484094

Locations
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00484094     History of Changes
Other Study ID Numbers: 0468X1-4411
B1741015 ( Other Identifier: Alias Study Number )
Study First Received: June 7, 2007
Results First Received: June 2, 2016
Last Updated: November 21, 2016

Keywords provided by Pfizer:
Rapamune
Safety
Efficacy
Kidney Transplantation

Additional relevant MeSH terms:
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2017