Trial information
A Study of Mircera for the Maintenance Treatment of Patients With Chronic Renal Anemia.
Status: Recruiting
Protocol number: ML20952
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 assess the efficacy and safety of intravenous Mircera when administered for the maintenance of hemoglobin levels in patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120, 200 or 360 micrograms iv) derived from the dose of epoetin alfa or darbepoetin alfa they were receiving in the week preceding study start. 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. Percentage of patients maintaining average Hb concentration within target range of 10.5-12.5g/dL during evaluation period. Time frame: Weeks 17-24
Key secondary outcomes: 1. Change in Hb concentration and percentage of patients maintaining Hb concentration in target range throughout evaluation period. Time frame: Weeks 17-24
2. Mean time in Hb target range; percentage of patients needing dose adjustments; incidence of RBC transfusions Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- stable epoetin alfa or darbepoetin alfa therapy for past 2 months;
- hemodialysis therapy for >=3 months.
Exclusion criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring hospitalization or interruption of erythropoetin treatment in previous 6 months;
- 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: January, 2008
Trial registration date: 09/17/2007
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Greece
- Agios Nikolaos Crete
- Arta
- Athens
- Corinthos
- Daphni-Athens
- Egaleo
- Ioannina
- Kalamata
- Kyparissia
- Lamia
- Larissa
- Leivadia
- Mitilini
- Patras
- Preveza
- Rhodes
- Thessaloniki
- Veria
