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Trial information
A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
Status: Terminated
Protocol number: ML20336
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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.
Brief summary: This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin levels, of Mircera and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on 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. Target sample size is
260.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: methoxy polyethylene glycol-epoetin beta [Mircera]
Primary outcome: 1. Time spent on anemia treatment over evaluation period Time frame: Months 7-9
2. Change in Hb concentration from baseline Time frame: Month 7
Key secondary outcomes: 1. AEs, laboratory parameters Time frame: Throughout study
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 Hb 10-12g/dL over last 3 months.
Exclusion criteria: - failed renal transplant within 12 months prior to screening;
- poorly controlled hypertension;
- previous treatment with Mircera.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 01/16/2007
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:United States - Birmingham, AL
- Rainbow City, AL
- Hot Springs, AZ
- Fairfield, CA
- Los Alamitos, CA
- Los Angeles, CA
- Mountain View, CA
- Riverside, CA
- San Diego , CA
- Simi Valley, CA
- Whittier, CA
- Lakewood, CO
- Brandon, FL
- Hudson, FL
- Lauderdale Lakes, FL
- Miami, FL
- Ocala, FL
- Palm Beach Gardens, FL
- Augusta, GA
- Gurnee, IL
- Fort Wayne, IN
- Detroit, MI
- Pontiac, MI
- Sparks, NV
- New Brunswick, NJ
- Bronx, NY
- Brooklyn, NY
- Brooklyn Center, NY
- Flushing, NY
- Orchard Park, NY
- Williamsville, NY
- Raleigh, NC
- Toledo, OH
- Tulsa , OK
- Lancaster, PA
- Lewistown, PA
- Philadelphia, PA
- West Homestead, PA
- Columbia, SC
- Orangeburg, SC
- Corpus Christi, TX
- Houston, TX
- Chesapeake , VA
- Fairfax , VA
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