A Study of Mircera for the Treatment of Anemia in Dialysis Patients

Completed · Phase 3

Conditions studied: Anemia

In brief

This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00077597

Run by

Hoffmann-La Roche

People needed

182

Starts

2004-02-01

Expected to finish

2006-06-01

Last updated by the study team

2016-11-02

Who can join

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

You may qualify if…

• adult patients >=18 years of age;
• chronic renal anemia;
• dialysis therapy for at least 2 weeks before screening.

You may not qualify if…

• women who are pregnant, breastfeeding or using unreliable birth control methods;
• administration of any investigational drug within 4 weeks before screening.

Where it is running

• Study site — Lakewood, Colorado, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Mineola, New York, United States
• Study site — New York, New York, United States
• Study site — Toledo, Ohio, United States
• Study site — Houston, Texas, United States
• Study site — Burlington, Vermont, United States
• Study site — Norfolk, Virginia, United States
• Study site — Curitiba, Brazil
• Study site — Ribeirão Preto, Brazil
• Study site — São Paulo, Brazil
• Study site — São Paulo, Brazil
• Study site — Calgary, Alberta, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Winnipeg, Manitoba, Canada
• Study site — St. John's, Newfoundland and Labrador, Canada
• Study site — Kingston, Ontario, Canada
• Study site — London, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Davis, California, United States

Full record on ClinicalTrials.gov

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