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Study Investigating Rapamune For Post-Marketing Surveillance

Last updated on April 11, 2018

FOR MORE INFORMATION
Study Location
Yeungnam University Medical Center
Daegu, , 705-717 Korea, Republic of
Contact
1-800-718-1021
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.

NCT00484094
Pfizer
Completed
Study Investigating Rapamune For Post-Marketing Surveillance

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Study Investigating Rapamune For Post-Marketing Surveillance
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
All patients who receive Rapamune for certain period of time should be included as far as patients consent to participate
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients who receive Rapamune after kidney transplantation
Kidney Transplantation
Drug: sirolimus
Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations
Other Name: Rapamune
Rapamune
Intervention: Drug: sirolimus
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
209
June 2015
June 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00484094
0468X1-4411
B1741015 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2016

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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