Study Investigating Rapamune For Post-Marketing Surveillance

November 21, 2016 updated by: Pfizer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

209

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who receive Rapamune after kidney transplantation

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rapamune
Drug: sirolimus
Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations
Other Names:
  • Rapamune

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
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.
Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 7, 2007

First Submitted That Met QC Criteria

June 7, 2007

First Posted (Estimate)

June 8, 2007

Study Record Updates

Last Update Posted (Estimate)

January 16, 2017

Last Update Submitted That Met QC Criteria

November 21, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0468X1-4411
  • B1741015 (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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