Trial information
A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis.
Status: Recruiting
Protocol number: NH20052
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label, randomized, multicenter, parallel-group study to demonstrate correction of anemia using once every 4 weeks subcutaneous injections of Mircera in patients with chronic kidney disease who are not on dialysis.
Brief summary: This 2 arm study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Patients will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kg, or darbepoetin alfa once weekly, at a starting dose of 0.45 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 300.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: methoxy polyethylene glycol-epoetin beta [Mircera]
Primary outcome: 1. Hb response rate, and change in average Hb concentration Time frame: Weeks 0-28
Key secondary outcomes: 1. Hb values and change over time; time to target Hb response; incidence of RBC transfusions; percentage of patients with stable Hb response; number of dose adjustments required Time frame: Throughout study
2. Percentage of patients with >=1 Hb >12g/dL Time frame: Weeks 0-8
3. AEs, laboratory parameters, vital signs Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic kidney disease;
- anemia;
- not on dialysis.
Exclusion criteria:
- previous therapy with any ESA within 12 weeks prior to screening;
- renal allograft in place;
- immunosuppressive therapy in the 12 weeks prior to screening.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: December, 2007
Trial registration date: 11/14/2007
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Australia
- Adelaide
- Gosford
- Melbourne
- Parkville
Belgium
Canada
- Edmonton, AB
- London, ON
- Toronto, ON
- Montreal, QC
China
France
- Cahors
- Clermont-Ferrand
- Limoges
- Lyon
- Paris
Germany
- Berlin
- Bonn
- Heilbronn
- Homburg
Greece
- Alexandroupolis
- Larissa
- Thessaloniki
- Volos
Hungary
- Baja
- Budapest
- Esztergom
- Hatvan
- Szigetvar
Israel
- Haifa
- Kfar Saba
- Petach-Tikva
Italy
- Como
- Ferrara
- Lecco
- Lodi
- Modena
- Pavia
- Venezia
Korea, Republic of
Poland
- Gdansk
- Katowice
- Krakow
- Lodz
- Radom
- Rzeszow
- Sieradz
- Szczecin
- Warszawa
- Wroclaw
- Zabrze
Russian Federation
Spain
- Barcelona
- Madrid
- Palma de Mallorca
- Sevilla
- Valencia
Taiwan
Thailand
- Bangkok
- Nakhon Ratchasima
- Pathumthani
