Trial information
A Study of Mircera in the Long Term Treatment of Patients With Renal Anemia.
Status: No longer recruiting
Protocol number: ML19382
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the safety and tolerability of long term Mircera treatment, and its effect on hemoglobin levels, in patients with chronic anemia.
Brief summary: This study will assess the efficacy, safety and tolerability of long term treatment with Mircera or reference medication in patients with chronic renal anemia who have participated in Phase II and Phase III Mircera trials (BA16528, BA16736, BA16738, BA16739, BA17283 and BA17284). Mircera or reference medication wil be administered at the same dose, and by the same route (iv or sc), as in the qualifying study. Target sample size is 150.
Study phase: III
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. Hemoglobin concentrations over time.
Key secondary outcomes: 1. AEs; laboratory parameters; vital signs.
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- maintenance treatment with Mircera or a protocol-specified reference medication in BA16528, BA16736, BA16738, BA16739, BA17283 or BA17284;
Exclusion criteria:
- poorly controlled hypertension necessitating interruption of erythropoietin treatment in previous 6 months;
- active malignant disease (except non-melanoma skin cancer);
- severe disease within 12 weeks of screening.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2005
Trial registration date: 06/16/2006
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Canada
- Edmonton, AB
- Kingston, ON
- Kitchener, ON
- London, ON
- Mississauga, ON
- Scarborough, ON
- Toronto, ON
- Greenfield Park, QC
- Montreal, QC
- Saskatoon, SK
