Back to resultsA Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
Primary Purpose
Anemia
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
methoxy polyethylene glycol-epoetin beta
Epoetin alfa
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- failed renal transplant within 12 months prior to screening;
- poorly controlled hypertension;
- previous treatment with Mircera.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
methoxy polyethylene glycol-epoetin beta
Epoetin Alfa
Arm Description
120-360 micrograms (iv) monthly, starting dose
As prescribed, (iv), 3 times weekly
Outcomes
Primary Outcome Measures
Time Spent on Anemia Treatment Over Evaluation Period
Efficacy and pharmacoeconomics analyses were not performed.
Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period
Efficacy and pharmacoeconomics analyses were not performed.
Secondary Outcome Measures
Number of Participants Assessed for AEs
The adverse events are captured in the adverse event and serious adverse event section of this database.
The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants
A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00422513
Brief Title
A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
Strategic decision unrelated to safety or efficacy
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
methoxy polyethylene glycol-epoetin beta
Arm Type
Experimental
Arm Description
120-360 micrograms (iv) monthly, starting dose
Arm Title
Epoetin Alfa
Arm Type
Active Comparator
Arm Description
As prescribed, (iv), 3 times weekly
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta
Other Intervention Name(s)
Mircera
Intervention Description
120-360 micrograms intravenous (iv) monthly, starting dose
Intervention Type
Drug
Intervention Name(s)
Epoetin alfa
Intervention Description
As prescribed, iv, 3 times weekly
Primary Outcome Measure Information:
Title
Time Spent on Anemia Treatment Over Evaluation Period
Description
Efficacy and pharmacoeconomics analyses were not performed.
Time Frame
Months 5-7
Title
Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period
Description
Efficacy and pharmacoeconomics analyses were not performed.
Time Frame
Baseline, Months 5-7
Secondary Outcome Measure Information:
Title
Number of Participants Assessed for AEs
Description
The adverse events are captured in the adverse event and serious adverse event section of this database.
Time Frame
Month 1 to 15 day follow up post month 7
Title
The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants
Description
A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount.
Time Frame
Baseline, Month 1 to Month 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
failed renal transplant within 12 months prior to screening;
poorly controlled hypertension;
previous treatment with Mircera.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Rainbow City
State/Province
Alabama
Country
United States
City
Hot Springs
State/Province
Arizona
Country
United States
City
Fairfield
State/Province
California
Country
United States
City
Los Alamitos
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Mountain View
State/Province
California
Country
United States
City
Riverside
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Simi Valley
State/Province
California
Country
United States
City
Whittier
State/Province
California
Country
United States
City
Lakewood
State/Province
Colorado
Country
United States
City
Brandon
State/Province
Florida
Country
United States
City
Hudson
State/Province
Florida
Country
United States
City
Lauderdale Lakes
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Ocala
State/Province
Florida
Country
United States
City
Palm Beach Gardens
State/Province
Florida
Country
United States
City
Augusta
State/Province
Georgia
Country
United States
City
Gurnee
State/Province
Illinois
Country
United States
City
Fort Wayne
State/Province
Indiana
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Pontiac
State/Province
Michigan
Country
United States
City
Sparks
State/Province
Nevada
Country
United States
City
New Brunswick
State/Province
New Jersey
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
Brooklyn Center
State/Province
New York
Country
United States
City
Brooklyn
State/Province
New York
Country
United States
City
Flushing
State/Province
New York
Country
United States
City
Orchard Park
State/Province
New York
Country
United States
City
Williamsville
State/Province
New York
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Toledo
State/Province
Ohio
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Lancaster
State/Province
Pennsylvania
Country
United States
City
Lewistown
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
West Homestead
State/Province
Pennsylvania
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Orangeburg
State/Province
South Carolina
Country
United States
City
Corpus Christi
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Chesapeake
State/Province
Virginia
Country
United States
City
Fairfax
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
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