Study Investigating Rapamune For Post-Marketing Surveillance

NCT00484094 | Completed Results

• 2 other identifiers: 0468X1-4411B1741015
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 11

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. 1.Unknown adverse reactions, especially serious adverse reactions
2. 2.To assess the incidence of adverse reactions under the routine drug uses
3. 3.Factors that may affect the safety of the drug (e.g., proteinuria)
4. 4.Factors that may affect the effectiveness of the drug

Conditions

Kidney Transplantation

Keywords

Rapamune; Safety; Efficacy; Kidney Transplantation

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs

  All AEs reported after the start of administration of Rapamune were considered as treatment-emergent AEs and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely", were considered as AEs whose causal relationship to the study drug could not be excluded and classified as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer.

  Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.

• Percentage of Participants With Clinically Significent Abnormal Laboratory Test

  Laboratory test was not mandatory because this study was a non-interventional study.

  Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.

Secondary Outcomes (4)

• Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies

  At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.

• Percentage of Participants Alive

  At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.

• Percentage of Participants With Survived Graft

  At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.

• Estimated Glomerular Filtration Rate (eGFR) Calculated by Nankivell Formula

  At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.

Study Arms (1)

Rapamune

Drug: sirolimus

Interventions

sirolimus DRUG

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

Also known as: Rapamune

Rapamune

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who receive Rapamune after kidney transplantation

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (11)

Seoul National University Hospital (SNUH)

Seoul, Seoul, 110-744, South Korea

Location

Yeungnam University Medical Center

Daegu, 705-717, South Korea

Location

The Catholic University of Korea Uijeongbu St. Mary's Hospital

Gyeonggi-do, 480-717, South Korea

Location

Maryknoll Medical Center

Pusan, 600-730, South Korea

Location

Kangdong Sacred Heart Hospital

Seoul, 134-814, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Gangnam Severance Hospital, Yonsei University Health System

Seoul, 135-720, South Korea

Location

Korea University Anam Hospital

Seoul, 136-705, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

Related Links

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

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

18007181021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2007
• First Posted: June 8, 2007
• Study Start: July 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 16, 2017
• Results First Posted: January 16, 2017

Record last verified: 2016-11

Locations

KR (11)