Trial information
A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Patients With Chronic Kidney Disease.
Status: Recruiting
Protocol number: ML20659
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label, multi-center study to demonstrate correction of anemia and to assess the maintenance of hemoglobin levels using subcutaneous once monthly injections of Mircera in pre-dialysis patients with chronic kidney disease
Brief summary: This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kg). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 200.
Study phase: III
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: methoxy polyethylene glycol-epoetin beta [Mircera]
Primary outcome: 1. Mean change in Hb concentration between baseline and evaluation period Time frame: Weeks 29 to 36
Key secondary outcomes: 1. Time to achievement of response, and mean time spent in Hb range of 11-13g/dL Time frame: Throughout study
2. Percentage of patients maintaining Hb concentration of 11-13g/dL throughout evaluation period Time frame: Weeks 29-36
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic kidney disease, stage 3 or 4;
- anemia (baseline Hb between 9 and 11g/dL).
Exclusion criteria:
- previous therapy with ESA within 12 weeks prior to screening;
- overt gastrointestinal bleeding, or bleeding episode necessitating transfusion within 8 weeks before screening;
- red blood cell transfusions within 8 weeks before screening;
- active malignant disease (except non-melanoma skin cancer).
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2008
Trial registration date: 04/17/2007
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Estonia
Finland
- Hus
- Jyvaeskylae
- Kajaani
- Kotka
- Kuopio
- Porvoo
- Tampere
- Turku
Latvia
- Jurmala
- Liepaja
- Riga
- Valmiera
Norway
- Honefoss
- Lillehammer
- Nordbyhagen
- Orkanger
- Oslo
- Stavanger
- Trondheim
