Trial information
A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
Status: Recruiting
Protocol number: ML21810
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A single arm, open label study to assess the efficacy, safety and tolerability of once-monthly administration of intravenous MIRCERA for the maintenance of haemoglobin levels in dialysis patients with chronic renal anaemia
Brief summary: This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms) every four weeks depending on the previous dose of epoetin alfa administered in the week preceding first study drug administration. Patients will be treated for 12 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. Proportion of patients maintaining Hb levels within the target range during the last 4 weeks of the treatment period. Time frame: Week 12
Key secondary outcomes: 1. Change in mean Hb concentration between reference and the last 4 weeks of the treatment period; mean time spent in Hb range 10.0g/dL - 12.0g/dL. Time frame: Week 12
2. Incidence of adverse events, serious adverse events 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 10.5g/dL - 12.5g/dL;
- continuous intravenous maintenance therapy with epoetin alfa at the same dosing interval during the previous 2 months.
Exclusion criteria:
- blood transfusion within the previous 2 months;
- 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
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
- Bangalore
- Chennai
- Hyderabad
- Kanpur
- Kolkata
- Mohali
- New Delhi
