Study Investigating Rapamune For Post-Marketing Surveillance

Kidney Transplantation Clinical Trial

Official title:

Post Marketing Surveillance Study To Observe Safety And Efficacy Of Rapamune

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484094
• Other study ID #: 0468X1-4411
• Secondary ID: B1741015
• Status: Completed
• Phase: N/A
• First received: June 7, 2007
• Last updated: October 23, 2015
• Start date: July 2011
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug SafetyKorea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	The Catholic University of Korea Uijeongbu St. Mary's Hospital	Gyeonggi-do
Korea, Republic of	Maryknoll Medical Center	Pusan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital (SNUH)	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events: Incidence, severity, and seriousness, outcome and causality of adverse events and discontinuation due to adverse events will be monitored.	adverse events occurred in usual practice	6 month	Yes
Primary	Clinically significant abnormal finding from laboratory test (if any)		6 month	Yes
Secondary	Incidence rate of biopsy-confirmed acute rejection using Banff 09 diagnostic categories for renal allograft biopsies	BCAR (biopsy confirmed acute rejection)	6 month	No
Secondary	Graft function: estimated glomerular filtration rate (eGFR) calculated using Nankivell formula		6 month	No
Secondary	Subject survival		6 month	No
Secondary	Graft survival		6 month	No

External Links

•   To obtain contact information for a study center near you, click here.