A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis

Completed · Phase 3

Conditions studied: Anemia

In brief

This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not 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

NCT00081471

Run by

Hoffmann-La Roche

People needed

324

Starts

2004-06-01

Expected to finish

2006-07-01

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 kidney disease;
• anemia;
• not on dialysis therapy;
• not receiving epoetin.

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 — Mather, California, United States
• Study site — Stanford, California, United States
• Study site — Stamford, Connecticut, United States
• Study site — Bay Pines, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Flushing, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Allentown, Pennsylvania, United States
• Study site — Columbia, South Carolina, United States
• Study site — Nashville, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Burlington, Vermont, United States
• Study site — Salem, Virginia, United States
• Study site — Morgantown, West Virginia, United States
• Study site — Clayton, Australia
• Study site — Liverpool, Australia
• Study site — Parkville, Australia
• Study site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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