Trial information
A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.
Status: Recruiting
Protocol number: BH20051
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study to compare the effect of monthly subcutaneous Mircera with that of darbepoetin alfa, given according to local label, on the management of anemia in patients with chronic kidney disease not on dialysis
Brief summary: This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is
264.
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. Change in Hb concentration between baseline and evaluation period Time frame: Months 7-9
Key secondary outcomes: 1. Hb concentration over time Time frame: Throughout study
2. RBC transfusions Time frame: To month 9
3. AEs, laboratory parameters Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic kidney disease, not requiring dialysis;
- receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and during screening/baseline period.
Exclusion criteria:
- overt gastrointestinal bleeding within 8 weeks before screening, or during screening/baseline period;
- transfusion of red blood cells within 8 weeks before screening, or during screening/baseline period;
- active malignant disease;
- previous treatment with Mircera.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: September, 2007
Trial registration date: 03/07/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Australia
- Gosford
- Herston
- Lismore
- Reservoir
- Richmond
Belgium
Canada
- Calgary, AB
- Kingston, ON
- Mississauga, ON
- Toronto, ON
- Montreal, QC
France
- La Tronche
- Nantes
- Orleans
- Paris
- Rennes
- St Priest En Jarez
- Strasbourg
Germany
- Bad König
- Berlin
- Bonn
- Coburg
- Demmin
- Dortmund
- München
Israel
- Hadera
- Jerusalem
- Kfar Saba
- Nahariya
- Rehovot
Italy
- Brescia
- Chieti
- Como
- Ferrara
- Genova
- La Spezia
- Lecco
- Lodi
- Palermo
- Pavia
- Prato
- Roma
Spain
- Barcelona
- Ciudad Real
- La Coruna
- Lerida
- Madrid
- Malaga
- Torrevieja
United Kingdom
United States
- Granada Hills, CA
- Washington, DC
- Lauderdale Lakes, FL
- Augusta, GA
- Kalispell, MT
- Mineola, NY
- Orchard Park, NY
- Raleigh, NC
- Columbus, OH
- Allentown, PA
- Providence, RI
- Chattanooga, TN
- Dallas, TX
- Mcallen, TX
- Salem, VA
- Morgantown, WV
