Trial information
A Study of Subcutaneous Mircera for the Maintenance Treatment of Patients With Chronic Renal Anemia Not on Dialysis.
Status: Recruiting
Protocol number: ML20937
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A single arm open label study to assess efficacy, safety and tolerability of once-monthly administration of subcutaneously Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis
Brief summary: This single arm study will assess the efficacy and safety of subcutaneous Mircera when administered for the maintenance of hemoglobin levels in patients with chronic renal anemia, not on dialysis. Patients currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of Mircera, with the starting dose (120, 200 or 360 micrograms s.c.) derived from the dose of darbepoetin alfa or epoetin beta 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: Week 17-24
2. Mean time in target range; percentage of patients needing dose adjustments; incidence of RBC transfusions. Time frame: Throughout study
3. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- stable darbepoetin alfa or epoetin beta therapy for past 8 weeks.
Exclusion criteria:
- transfusion of red blood cells during previous 8 weeks;
- poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months;
- acute or chronic bleeding requiring therapy within previous 8 weeks.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: March, 2008
Trial registration date: 03/18/2008
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Netherlands
- Alkmaar
- Almelo
- Amersfoort
- Amsterdam
- Assen
- Beverwijk
- Breda
- Delft
- Doetinchem
- Drachten
- Goes
- Gouda
- Hoogeveen
- Leiderdorp
- Maastricht
- Nijmegen
- Rotterdam
- 'S Hertogenbosch
- Utrecht
