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Study Investigating Rapamune For Post-Marketing Surveillance

NCT00484094 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 209

Last updated 2017-01-16

Study results available
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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

Conditions

  • Kidney Transplantation

Interventions

DRUG

sirolimus

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00484094 on ClinicalTrials.gov