Study Investigating Rapamune For Post-Marketing Surveillance

NCT00484094

Last updated date
Study Location
Yeungnam University Medical Center
Daegu, , 705-717, Korea, Republic of
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title Study Investigating Rapamune For Post-Marketing Surveillance
Official Title Post Marketing Surveillance Study To Observe Safety And Efficacy Of Rapamune
Brief Summary

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
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who receive Rapamune after kidney transplantation
Condition Kidney Transplantation
Intervention Drug: sirolimus
Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations
Other Name: Rapamune
Study Groups/Cohorts Rapamune
Intervention: Drug: sirolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 17, 2015)
209
Original Enrollment
 (submitted: June 7, 2007)
600
Actual Study Completion Date June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:All
Ages 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT00484094
Other Study ID Numbers 0468X1-4411
B1741015 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2016