A Study of Intravenous 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 intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00077610

Run by

Hoffmann-La Roche

People needed

673

Starts

2004-02-01

Expected to finish

2005-08-01

Last updated by the study team

2017-01-13

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;
• on dialysis therapy for at least 12 weeks before screening;
• receiving IV epoetin for at least 8 weeks before screening.

You may not qualify if…

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

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Montgomery, Alabama, United States
• Study site — Encino, California, United States
• Study site — Irvine, California, United States
• Study site — Los Angeles, California, United States
• Study site — Monterey Park, California, United States
• Study site — Riverside, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — San Jose, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Lakewood, Colorado, United States
• Study site — Ocala, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Maywood, Illinois, United States
• Study site — Louisville, Kentucky, United States
• Study site — Covington, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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