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Completed

NCT Number: NCT00484094

Study Investigating Rapamune For Post-Marketing Surveillance

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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Key information

Conditions

Kidney Transplantation

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital (SNUH), Seoul, South Korea

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sirolimus

Drug

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

Other names: Rapamune

Primary outcomes

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

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

    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.

  2. Percentage of Participants With Clinically Significent Abnormal Laboratory Test

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

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

Secondary outcomes

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

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

    Renal biopsy was required to confirm the diagnosis of acute rejection. However, due to the non-interventional nature of this study, biopsy could not be mandatory. The decision of whether to perform a biopsy was made at the discretion of the investigator and the result was collected if performed.

  2. Percentage of Participants Alive

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

    The investigator recorded the participant's survival status and evaluation date on the CRF.

  3. Percentage of Participants With Survived Graft

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

    Graft survival was defined as not showing graft loss at the time of evaluation.

  4. Estimated Glomerular Filtration Rate (eGFR) Calculated by Nankivell Formula

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

    Graft function was evaluated by eGFR using Nankivell formula. The investigator recorded the date of evaluation and the calculated value on the CRF.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Post Marketing Surveillance Study To Observe Safety And Efficacy Of Rapamune

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 8, 2007
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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