Trial information
A Study of Intravenous Mircera for the Treatment of Anemia in Pediatric Patients on Hemodialysis.
Status: Recruiting
Protocol number: NH19707
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label multi-center, multiple dose study to determine the optimum starting dose of intravenous MIRCERA for maintenance treatment of anemia in pediatric patients with chronic kidney disease on dialysis.
Brief summary: This sequential study will assess the efficacy and safety of multiple doses of intravenous Mircera, and will determine the optimum starting dose for maintenance treatment of anemia in children with chronic kidney disease on hemodialysis. Pediatric patients will remain on epoetin alfa, epoetin beta or darbepoetin alfa during the screening period, after which they will receive intravenous Mircera monthly, at a starting dose related to the previous weekly epoetin or darbepoetin alfa dose. Depending on the response achieved, another group may be selected to receive a higher or a lower dose. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is
41.
Study phase: II
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. Change in Hb concentration between baseline and evaluation period Time frame: Weeks 17-20
Key secondary outcomes: 1. Number of patients with average Hb concentration above, below or within range of 10-12g/dL during evaluation period Time frame: Weeks 17-20
2. Incidence of RBC transfusions, reticulocyte counts, AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- children aged 5-17 years with clinically stable chronic renal anemia;
- hemodialysis for >=8 weeks;
- intravenous stable maintenance epoetin alfa, epoetin beta or darbepoetin alfa for >= 8 weeks before screening;
- stable maintenance epoetin alfa, epoetin beta or darbepoetin alfa with no more than one dose change <=25% during the 2 weeks of screening.
Exclusion criteria:
- overt gastrointestinal bleeding, or bleeding episode necessitating transfusion within 8 weeks before screening;
- red blood cell transfusions within 8 weeks before screening;
- active malignant disease.
Gender: Males or Females
Age limits: Min: 5 Years Max: 17 Years
Accepts healthy volunteers: No
Trial registration date: 07/15/2008
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Australia
Belgium
France
Germany
Hungary
Italy
- Genova
- Padova
- Roma
- Torino
Poland
- Szczecin
- Warszawa
- Wroclaw
Spain
- Barcelona
- Madrid
- Sevilla
- Valencia
