Trial information
STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients
Status: Recruiting
Protocol number: ML21040
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: MIRCEA in ESRD
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 dialysis 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 dialysis patients with chronic renal anemia. Patients will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. 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 average Hb conc. within the target range during the Efficacy Evaluation Period (EEP) Time frame: Weeks 17-24
Key secondary outcomes: 1. Change in Hb conc. Time frame: Between reference and EEP
2. % patients maintaining Hb within target range Time frame: Weeks 17-24
3. % patients requiring dose adjustments; incidence of RBC transfusions Time frame: Weeks 1-24
4. AEs, lab parameters Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- continuous stable iv maintenance epoetin therapy during previous month;
- 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 erythropoietin 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: November, 2007
Trial registration date: 03/18/2008
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Czech Republic
- Brno
- Cesky Krumlov
- Decin
- Havirov
- Hradec Kralove
- Jihlava
- Karlovy Vary
- Kolin Iii
- Liberec
- Novy Jicin
- Olomouc
- Ostrava
- Pisek
- Praha
- Strakonice
- Sumperk
- Tabor
- Teplice
- Trebic
- Usti Nad Labem
- Znojmo
