A Study of Intravenous or Subcutaneous 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 (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00081484

Run by

Hoffmann-La Roche

People needed

336

Starts

2004-06-01

Expected to finish

2006-03-01

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;
• on dialysis therapy for at least 12 weeks before screening;
• receiving iv or sc 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 — Los Alamitos, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Tampa, Florida, United States
• Study site — Honolulu, Hawaii, United States
• Study site — South Holland, Illinois, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Kalamazoo, Michigan, United States
• Study site — Columbus, Mississippi, United States
• Study site — Tupelo, Mississippi, United States
• Study site — St Louis, Missouri, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Flushing, New York, United States
• Study site — New York, New York, United States
• Study site — Orchard Park, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Oregon City, Oregon, United States
• Study site — Erie, Pennsylvania, United States
• Study site — Lewistown, Pennsylvania, United States
• Study site — Covina, California, United States

Full record on ClinicalTrials.gov

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