Trial information
A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia
Status: Completed
Protocol number: BA16285
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of dose conversion factors for maintenance intravenous Mircera in hemodialysis patients with chronic renal anemia
Brief summary: This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.
Target sample size is 90.
Study phase: II
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: methoxy polyethylene glycol-epoetin beta [Mircera]
Primary outcome: 1. Change in hemoglobin from baseline over time under constant dosing regimen
Time frame: Throughout study
Key secondary outcomes: 1. Change in hematocrit from baseline over time under constant dosing regimen. Vital signs, adverse events, laboratory values
Time frame: Throughout study
Inclusion criteria:
- adult patients >=18 years of age;
- chronic renal anemia;
- on hemodialysis therapy for at least 3 months;
- receiving iv epoetin alfa during the 2 weeks prior to the run-in period.
Exclusion criteria:
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- use of any investigational drug within 30 days of the run-in phase, or during the run-in or study treatment period.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
United States
- Birmingham, AL
- Los Angeles, CA
- Maywood, IL
- Louisville, KY
- Detroit, MI
- Brooklyn Center, MN
- Las Vegas, NV
- Paterson, NJ
- Brooklyn, NY
- Mineola, NY
- New York, NY
- Nashville, TN
- Morgantown, WV
