Study Stopped
Strategic decision unrelated to safety or efficacy
A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
A Randomized, Open-label Study Comparing the Pharmacoeconomic (Time and Motion) Benefit of Mircera and Epoetin Alfa in Patients With Chronic Kidney Disease (Stage V) on Dialysis.
1 other identifier
interventional
260
1 country
44
Brief Summary
This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2007
Shorter than P25 for phase_3
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2007
CompletedFirst Posted
Study publicly available on registry
January 17, 2007
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
December 14, 2011
CompletedDecember 14, 2011
November 1, 2011
9 months
January 15, 2007
March 29, 2011
November 9, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
Time Spent on Anemia Treatment Over Evaluation Period
Efficacy and pharmacoeconomics analyses were not performed.
Months 5-7
Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period
Efficacy and pharmacoeconomics analyses were not performed.
Baseline, Months 5-7
Secondary Outcomes (2)
Number of Participants Assessed for AEs
Month 1 to 15 day follow up post month 7
The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants
Baseline, Month 1 to Month 7
Study Arms (2)
methoxy polyethylene glycol-epoetin beta
EXPERIMENTAL120-360 micrograms (iv) monthly, starting dose
Epoetin Alfa
ACTIVE COMPARATORAs prescribed, (iv), 3 times weekly
Interventions
120-360 micrograms intravenous (iv) monthly, starting dose
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- CKD (stage V) on outpatient hemodialysis therapy for \>= 3 months;
- CKD-related anemia treated with epoetin alfa iv 3x/week for \>= 3 months;
- average hemoglobin (Hb) 10-12 g/dL over last 3 months.
You may not qualify if:
- failed renal transplant within 12 months prior to screening;
- poorly controlled hypertension;
- previous treatment with Mircera.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Rainbow City, Alabama, United States
Unknown Facility
Hot Springs, Arizona, United States
Unknown Facility
Fairfield, California, United States
Unknown Facility
Los Alamitos, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Mountain View, California, United States
Unknown Facility
Riverside, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Simi Valley, California, United States
Unknown Facility
Whittier, California, United States
Unknown Facility
Lakewood, Colorado, United States
Unknown Facility
Brandon, Florida, United States
Unknown Facility
Hudson, Florida, United States
Unknown Facility
Lauderdale Lakes, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Ocala, Florida, United States
Unknown Facility
Palm Beach Gardens, Florida, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Gurnee, Illinois, United States
Unknown Facility
Fort Wayne, Indiana, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Pontiac, Michigan, United States
Unknown Facility
Sparks, Nevada, United States
Unknown Facility
New Brunswick, New Jersey, United States
Unknown Facility
Brooklyn, New York, United States
Unknown Facility
Brooklyn Center, New York, United States
Unknown Facility
Flushing, New York, United States
Unknown Facility
Orchard Park, New York, United States
Unknown Facility
The Bronx, New York, United States
Unknown Facility
Williamsville, New York, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Lancaster, Pennsylvania, United States
Unknown Facility
Lewistown, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
West Homestead, Pennsylvania, United States
Unknown Facility
Columbia, South Carolina, United States
Unknown Facility
Orangeburg, South Carolina, United States
Unknown Facility
Corpus Christi, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Chesapeake, Virginia, United States
Unknown Facility
Fairfax, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2007
First Posted
January 17, 2007
Study Start
March 1, 2007
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
December 14, 2011
Results First Posted
December 14, 2011
Record last verified: 2011-11