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Study Investigating Rapamune For Post-Marketing Surveillance

Last updated on October 12, 2019

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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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Descriptive Information
Brief TitleStudy Investigating Rapamune For Post-Marketing Surveillance
Official TitlePost 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 DescriptionAll patients who receive Rapamune for certain period of time should be included as far as patients consent to participate
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients who receive Rapamune after kidney transplantation
ConditionKidney Transplantation
InterventionDrug: sirolimus
Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations
Other Name: Rapamune
Study Groups/CohortsRapamune
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 StatusCompleted
Actual Enrollment
 (submitted: September 17, 2015)
209
Original Enrollment
 (submitted: June 7, 2007)
600
Actual Study Completion DateJune 2015
Actual Primary Completion DateJune 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
Ages13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesKorea, Republic of
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00484094
Other Study ID Numbers0468X1-4411
B1741015 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2016

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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