Trial information
MIRACLE Study: A Study Of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.
Status: Recruiting
Protocol number: ML20826
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A single arm, open label, interventional multicenter study to 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.
Brief summary: This single arm study will assess the long-term maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients with chronic renal anemia. Patients currently receiving darbepoetin alfa, epoetin alfa or epoetin beta maintenance treatment will receive intravenous Mircera at a starting dose of 120 or 200 micrograms/month (based on the ESA dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the country-specific target range (11-13g/dL for Switzerland and 10-12g/dL for Austria). The anticipated time on study treatment is 1-2 years, 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 country-specific target range (11-13g/dL for Switzerland and 10-12g/dL for Austria) OR +/- 1g/dL of reference Hb concentration during evaluation period. Time frame: Weeks 17-24
Key secondary outcomes: 1. Change in Hb concentration between reference and evaluation period Time frame: Week 17-24
2. Mean time spent in country-specific target range; percentage of patients maintaining Hb within target range; dose adjustments; RBC transfusions. Time frame: Throughout study
3. AEs, laboratory parameters, vital signs Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- Hb conc. in country-specific target range (Switzerland: 11g/dL-13g/dL; Austria: 10g/dL-12g/dL);
- regular long-term hemodialysis therapy with the same mode of dialysis for >=3 months;
- continuous iv or sc maintenance ESA treatment during previous 2 months.
Exclusion criteria:
- transfusion of red blood cells during previous 2 months;
- significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
- active malignant disease (except non-melanoma skin cancer).
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: October, 2007
Trial registration date: 10/15/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Austria
- Bregenz
- Feldkirch
- Graz
- Kufstein
- Linz
- Salzburg
- St Pölten
- Steyr
- Wien
Switzerland
- Basel
- Bellinzona
- Burgdorf
- Geneve
- Lausanne
- Liestal
- Locarno
- Lugano
- Mendrisio
- Sion
- St Gallen
- Zürich
