Trial information
A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia
Status: Recruiting
Protocol number: ML21096
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 C.E.R.A. for the maintenance of haemoglobin levels in haemodialysis patients with chronic renal anaemia.
Brief summary: This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. 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. % patients maintaining mean Hb conc. within target range during the Efficacy Evaluation Period (EEP) Time frame: Weeks 16-24
Key secondary outcomes: 1. Change in mean Hb conc. Time frame: Between reference and EEP
2. % patients maintaining Hb within target range Time frame: Weeks 16-24
3. % patients requiring dose adjustments; incidence of RBC transfusions Time frame: Weeks 0-24
4. AEs, lab parameters Time frame: Throughout study
Inclusion criteria:
- adult patients, >= 18 years of age;
- chronic renal anemia;
- continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;
- regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.
Exclusion criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring hospitalization or interruption of epoetin treatment in previous 6 months;
- significant acute or chronic bleeding.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2008
Trial registration date: 04/15/2008
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Turkey
- Adana
- Ankara
- Aydin
- Diyarbakir
- Edirne
- Elazig
- Erzurum
- Istanbul
- Izmir
- Kayseri
- Malatya
- Mersin
