A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.

Stopped early · Phase 3

Conditions studied: Anemia

In brief

This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through dialysis. Patients will be randomized either to receive Mircera or to remain on their existing therapy; the initial monthly dose of subcutaneous (sc) Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation of dialysis, patients in the Mircera group will receive monthly intravenous (iv) Mircera at a starting dose based on their previous (sc) dose, and those in the control group will receive weekly (iv) epoetin alfa. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.

Key facts

Study ID

NCT00454246

Run by

Hoffmann-La Roche

People needed

111

Starts

2007-04-01

Expected to finish

2008-02-01

Last updated by the study team

2011-12-16

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 stage IV not requiring dialysis;
• expected to initiate dialysis within 18 months;
• 15<=Glomerular Filtration Rate (GFR)<=29.

You may not qualify if…

• failing renal allograft in place;
• acute or chronic bleeding within 8 weeks prior to screening;
• transfusion of red blood cells within 8 weeks prior to screening;
• poorly controlled hypertension;
• immunosuppressive therapy in the 12 weeks prior to screening.

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — El Dorado, Arkansas, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Bakersfield, California, United States
• Study site — Glendale, California, United States
• Study site — Granada Hills, California, United States
• Study site — Los Angeles, California, United States
• Study site — Orange, California, United States
• Study site — Palm Springs, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — Yuba City, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Lakewood, Colorado, United States
• Study site — Stamford, Connecticut, United States
• Study site — Miami, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Palm Beach Gardens, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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