A Study Of Mircera In Patients With Kidney Disease Who Are Not On Dialysis
Mircera In Patients With CKD Stages III-IV Not On Dialysis: Observational, Non-interventional Cohort Study
1 other identifier
observational
153
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2009
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 2, 2015
CompletedFirst Posted
Study publicly available on registry
July 3, 2015
CompletedAugust 18, 2015
August 1, 2015
2.2 years
July 2, 2015
August 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Of Participants Who Reached And Maintained Target Hemoglobin Values During Treatment
12 months
Secondary Outcomes (5)
Hb Levels At Start And End Of Treatment
12 months
Mircera Dose At Start And End Of Treatment
12 months
Time To Achieve Response To Mircera
12 months
Percent Of Participants Treated With Iron Supplements
12 months
Percent of Participants Who Required Transfusion At Start And End Of Treatment
12 months
Study Arms (1)
Mircera
Patients with stage III-IV CKD received open-label Mircera for 12 months at a dose to be determined by the investigator.
Interventions
Eligibility Criteria
Patients 18 to 75 years old with stage III-IV chronic kidney disease not on dialysis
You may qualify if:
- Patients with stage II-IV CKD not on dialysis, including renal transplant patients, who are receiving erythropoiesis-stimulating agent (ESA) treatment or are ESA-naive
- Patients who will not require dialysis within 12 months after the start of Mircera therapy
- Patients whose life expectancy is greater than 12 months after Mircera initiation
- Patients \>/= 18 years and \</= 75 years of age
- Patients who are female and of childbearing potential must be using effective contraception methods
- Patients with no contra-indications to ESA treatment (for example, hypersensitivity, non-controlled hypertension and others according to the local SmPC)
- Patients who have given written informed consent where local regulations allow or require it
You may not qualify if:
- Patients with stage I-II or stage V CKD
- Poorly controlled hypertension
- Active malignant disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Unknown Facility
Belgrade, 11000, Serbia
Unknown Facility
Ćuprija, 35230, Serbia
Unknown Facility
Kragujevac, 34000, Serbia
Unknown Facility
Niš, 18000, Serbia
Unknown Facility
Pirot, 18300, Serbia
Unknown Facility
Požarevac, 12000, Serbia
Unknown Facility
Sremska Mitrovica, 22000, Serbia
Unknown Facility
Šabac, 15000, Serbia
Unknown Facility
Užice, 31000, Serbia
Unknown Facility
Zrenjanin, 23000, Serbia
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2015
First Posted
July 3, 2015
Study Start
December 1, 2009
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
August 18, 2015
Record last verified: 2015-08