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