Study Investigating Rapamune For Post-Marketing Surveillance

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00484094
First received: June 7, 2007
Last updated: June 20, 2014
Last verified: June 2014
  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 Phase
Kidney Transplantation
Drug: sirolimus
Phase 4

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 ]

Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 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
Genders Eligible for Study:   Both
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

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00484094     History of Changes
Other Study ID Numbers: 0468X1-4411, B1741015
Study First Received: June 7, 2007
Last Updated: June 20, 2014
Health Authority: Korea: Ministry of Food and Drug Safety
Korea: Food and Drug Administration

Keywords provided by Pfizer:
Rapamune
Safety
Efficacy
Kidney Transplantation

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

ClinicalTrials.gov processed this record on July 20, 2014