Trial information
A Study of Subcutaneous Mircera for the Maintenance Treatment of Pre-Dialysis Patients With Chronic Renal Anemia.
Status: No longer recruiting
Protocol number: ML20944
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to assess the maintenance of hemoglobin levels, safety and tolerability of once monthly administration of subcutaneous Mircera in pre-dialysis patients with chronic renal anemia
Brief summary: This single arm study will assess the efficacy and safety of subcutaneous Mircera for maintenance of hemoglobin levels in pre-dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of Mircera with the starting dose (120, 200 or 360 micrograms) derived from the dose of darbepoetin alfa or epoetin alfa 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 in target range 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 during evaluation period Time frame: Weeks 17-24
2. Mean time spent 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;
- continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval during previous 2 months.
Exclusion criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring hospitalization or interruption of darbepoetin alfa 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: July, 2007
Trial registration date: 08/15/2007
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Sweden
- Bollnas
- Danderyd
- Eksjo
- Eskilstuna
- Gaevle
- Goeteborg
- Gothenburg
- Huddinge
- Jonkoping
- Kristianstad
- Skellefteå
- Umea
- Värnamo
- Västervik
