Trial information
A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.
Status: Recruiting
Protocol number: ML21822
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A single arm, open label study to assess the efficacy, safety and tolerability of two weekly administration of intravenous MIRCERA for the treatment of chronic renal anaemia in dialysis patients not currently treated with ESA.
Brief summary: This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is
170.
Study phase: IV
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 from baseline to last visit Time frame: Week 16
Key secondary outcomes: 1. Time to achievement of response (Hb target range 10.0g/dL - 12g/dL); percentage of patients with average Hb concentration between 10.0g/dL and 12.0g/dL during that last 4 weeks of treatment. Time frame: Week 16
2. Mean time spent in the Hb range 10.0g/dL - 12.0g/dL during the last 4 weeks of treatment. Time frame: Week 16
3. Incidence of AEs, SAEs and deaths; vital signs, laboratory parameters, ECG. Time frame: Throughout study
Inclusion criteria:
- male or female patients, >=18 years of age;
- chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);
- no prior erythropoietin stimulating agent (ESA) therapy.
Exclusion criteria:
- blood transfusion within the previous 4 weeks;
- poorly controlled hypertension;
- significant acute or chronic bleeding;
- active malignant disease;
- congestive heart failure (NYHA Class IV).
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2008
Trial registration date: 08/15/2008
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
India
- Ahmedabad
- Bangalore
- Chennai
- Coimbatore
- Gujarat
- Hyderabad
- Kerala
- Kolkata
- Ludhiana
- Mumbai
- New Delhi
- Vellore
- Vishakpatnam
