Clinical trial NCT00484094: Study Investigating Rapamune For Post-Marketing Surveillance
Official title: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Rapamune
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Keywords: Rapamune
Safety
Efficacy
Kidney Transplantation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-08
Enrollment: 209
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who receive Rapamune after kidney transplantation

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

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.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs
timeFrame: Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
measure: Percentage of Participants With Clinically Significent Abnormal Laboratory Test
timeFrame: Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.
Secondary outcomes:
measure: Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies
timeFrame: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
measure: Percentage of Participants Alive
timeFrame: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
measure: Percentage of Participants With Survived Graft
timeFrame: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
measure: Estimated Glomerular Filtration Rate (eGFR) Calculated by Nankivell Formula
timeFrame: At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea Uijeongbu St. Mary's Hospital
city: Pusan
country: Korea, Republic of
facility: Maryknoll Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital (SNUH)
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: