Study Investigating Rapamune For Post-Marketing Surveillance

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Detailed Description

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

Conditions

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Kidney Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rapamune

sirolimus

Intervention Type DRUG

Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations

Interventions

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sirolimus

Dosage and treatment duration will be decided by physician's discretion considering patient's clinical situations

Intervention Type DRUG

Other Intervention Names

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Rapamune

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No