A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.

Completed · Phase 2

Conditions studied: Anemia

In brief

This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.

Key facts

Study ID

NCT00048048

Run by

Hoffmann-La Roche

People needed

65

Starts

2002-03-01

Expected to finish

2004-11-01

Last updated by the study team

2018-01-02

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;
• not receiving renal replacement therapy.

You may not qualify if…

• women who are pregnant, breastfeeding or using unreliable birth control methods;
• administration of any investigational drug within 30 days preceding the screening visit and during the run-in period.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — San Diego, California, United States
• Study site — Detroit, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Portland, Oregon, United States
• Study site — Edmonton, Alberta, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Mexico City, Mexico
• Study site — Monterrey, Mexico
• Study site — Gdansk, Poland
• Study site — Krakow, Poland
• Study site — Wroclaw, Poland
• Study site — Belfast, United Kingdom
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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