Trial information
A Study of Intravenous Mircera in Patients With Chronic Renal Anemia who are on Dialysis.
Status: Recruiting
Protocol number: ML20752
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 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 and safety of monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia in routine clinical practice in Hungary. Patients currently receiving maintenance treatment with intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the starting dose derived from the ESA dose they had been receiving. 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. Proportion of patients maintaining average Hb concentration within target range during the Efficacy Evaluation Period (EEP) Time frame: Week 17-24
Key secondary outcomes: 1. Change in Hb concentration Time frame: Between reference and EEP
2. Percentage of patients maintaining Hb within target range. Time frame: Weeks 17-24
3. Percentage of patients requiring dose adjustments; incidence of RBC transfusions. Time frame: Weeks 0-24
4. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- continuous stable intravenous maintenance epoetin or darbepoetin therapy during previous month;
- regular long term dialysis therapy, with the same mode of dialysis for the previous 3 months.
Exclusion criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension;
- 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: June, 2008
Trial registration date: 04/15/2008
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Hungary
- Baja
- Budapest
- Debrecen
- Esztergom
- Hodmezovasarhely
- Kalocsa
- Karcag
- Kecskemet
- Keszthely
- Miskolc
- Pecs
- Salgótarján
- Szolnok
- Vac
- Zalaegerszeg
