Clinical Trial: A Study Of Mircera In Patients With Kidney Disease Who Are Not On Dialysis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Mircera In Patients With CKD Stages III-IV Not On Dialysis: Observational, Non-interventional Cohort Study

Brief Summary: This open-label, non-randomized, retrospective-prospective, non-interventional study will evaluate the efficacy and safety of Mircera in patients with stage III-IV chronic kidney disease (CKD) not on dialysis. Patients will receive open-label treatment with Mircera for 12 months at a dose to be determined by the investigator.

Detailed Summary:
Sponsor: Hoffmann-La Roche

Current Primary Outcome: Percent Of Participants Who Reached And Maintained Target Hemoglobin Values During Treatment [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hb Levels At Start And End Of Treatment [ Time Frame: 12 months ]
  • Mircera Dose At Start And End Of Treatment [ Time Frame: 12 months ]
  • Time To Achieve Response To Mircera [ Time Frame: 12 months ]
  • Percent Of Participants Treated With Iron Supplements [ Time Frame: 12 months ]
  • Percent of Participants Who Required Transfusion At Start And End Of Treatment [ Time Frame: 12 months ]


Original Secondary Outcome:

  • hemoglobin (Hb) Levels At Start And End Of Treatment [ Time Frame: 12 months ]
  • Mircera Dose At Start And End Of Treatment [ Time Frame: 12 months ]
  • Time To Achieve Response To Mircera [ Time Frame: 12 months ]
  • Percent Of Participants Treated With Iron Supplements [ Time Frame: 12 months ]
  • Percent of Participants Who Required Transfusion At Start And End Of Treatment [ Time Frame: 12 months ]


Information By: Hoffmann-La Roche

Dates:
Date Received: July 2, 2015
Date Started: December 2009
Date Completion:
Last Updated: August 17, 2015
Last Verified: August 2015