A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia.

Completed · Phase 2

Conditions studied: Anemia

In brief

This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00364832

Run by

Hoffmann-La Roche

People needed

137

Starts

2001-10-01

Expected to finish

2005-07-01

Last updated by the study team

2016-12-20

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 (hemodialysis or peritoneal dialysis) therapy for at least 3 months;
• receiving sc epoetin alfa or beta for at least 3 months prior to the run-in period.

You may not qualify if…

• women who are pregnant, breastfeeding or using unreliable birth control methods;
• use of any investigational drug within 30 days preceding the run-in phase, or during the run-in or study treatment period.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — San Jose, California, United States
• Study site — Boston, Massachusetts, United States
• Study site — Cleveland, Ohio, United States
• Study site — Houston, Texas, United States
• Study site — Morgantown, West Virginia, United States
• Study site — Berlin, Germany
• Study site — Mannheim, Germany
• Study site — Villingen-Schwenningen, Germany
• Study site — Wiesloch, Germany
• Study site — Bari, Italy
• Study site — Bergamo, Italy
• Study site — Lecco, Italy
• Study site — Lodi, Italy
• Study site — Milan, Italy
• Study site — Modena, Italy
• Study site — Pavia, Italy
• Study site — Vicenza, Italy
• Study site — Barcelona, Spain
• Study site — Madrid, Spain
• Study site — Madrid, Spain
• Study site — Málaga, Spain
• Study site — Santander, Spain

Full record on ClinicalTrials.gov

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