A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

Stopped early · Phase 3

Conditions studied: Anemia

In brief

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.

Key facts

Study ID

NCT00422513

Run by

Hoffmann-La Roche

People needed

260

Starts

2007-03-01

Expected to finish

2007-12-01

Last updated by the study team

2011-12-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Rainbow City, Alabama, United States
• Study site — Hot Springs, Arizona, United States
• Study site — Fairfield, California, United States
• Study site — Los Alamitos, California, United States
• Study site — Los Angeles, California, United States
• Study site — Mountain View, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — Simi Valley, California, United States
• Study site — Whittier, California, United States
• Study site — Lakewood, Colorado, United States
• Study site — Brandon, Florida, United States
• Study site — Hudson, Florida, United States
• Study site — Lauderdale Lakes, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Palm Beach Gardens, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Gurnee, Illinois, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Detroit, Michigan, United States
• Study site — Pontiac, Michigan, United States
• Study site — Sparks, Nevada, United States
• Study site — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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