A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.

Completed · Phase 3

Conditions studied: Anemia

In brief

This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00442702

Run by

Hoffmann-La Roche

People needed

228

Starts

2007-09-01

Expected to finish

2010-08-01

Last updated by the study team

2011-12-19

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, not requiring dialysis;
• receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and during screening/baseline period.

You may not qualify if…

• overt gastrointestinal bleeding within 8 weeks before screening, or during screening/baseline period;
• transfusion of red blood cells within 8 weeks before screening, or during screening/baseline period;
• active malignant disease;
• previous treatment with Mircera.

Where it is running

• Study site — Lauderdale Lakes, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Mineola, New York, United States
• Study site — Orchard Park, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Oregon City, Oregon, United States
• Study site — Providence, Rhode Island, United States
• Study site — Chattanooga, Tennessee, United States
• Study site — Salem, Virginia, United States
• Study site — Morgantown, West Virginia, United States
• Study site — Adelaide, Australia
• Study site — Gosford, Australia
• Study site — Lismore, Australia
• Study site — Reservoir, Australia
• Study site — Richmond, Australia
• Study site — Aalst, Belgium
• Study site — Roeselare, Belgium
• Study site — Calgary, Alberta, Canada
• Study site — St. John's, Newfoundland and Labrador, Canada
• Study site — Kingston, Ontario, Canada
• Study site — Mississauga, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Granada Hills, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.