Trial information

A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients.

Status: No longer recruiting

Protocol number: BH17847

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific Title: A randomized, open label study to compare the effect of Mircera with that of darbepoetin alfa, administered intravenously at extended dosing intervals, for the maintenance treatment of anemia in patients with chronic kidney disease who are on hemodialysis.

Brief summary: This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease who are on hemodialysis. Eligible patients receiving once-weekly intravenous darbepoetin alfa maintenance treatment will be randomized to receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 488.

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. Percentage of patients with average Hb decrease from baseline <=1.0g/dL, and an average Hb >=10.5g/dL Time frame: Weeks 50 - 53

Key secondary outcomes: 1. Change in dose over time Time frame: Week 27 to months 11 and 12 2. AEs, laboratory parameters, vital signs Time frame: Throughout study

Inclusion criteria:

• adult patients, >=18 years of age;
• chronic renal anemia;
• hemodialysis 3 times weekly for >=12 weeks before screening, and during screening/baseline period;
• receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and during screening/baseline period.

Exclusion criteria:

• overt gastrointestinal bleeding within 8 weeks before screening or during screening/baseline period;
• transfusion of red blood cells within 8 weeks before screening or during screening/baseline period;
• active malignancy;

Gender: Males or Females

Age limits: Min: 18 Years Max: N/A (No limit)

Accepts healthy volunteers: No

Anticipated start date: January, 2007

Trial registration date: 10/17/2006

Date last updated: 11/21/2008

Link to trial result

This trial was conducted at the following locations:

Australia

• Adelaide
• Gosford
• Melbourne
• Parkville
• Woolloongabba

Austria

• Linz
• Wien

Belgium

• Aalst
• Bruxelles
• Roeselare

Canada

• Calgary, AB
• Hamilton, ON
• Kitchener, ON
• Mississauga, ON
• Ottawa, ON
• Toronto, ON
• Greenfield Park, QC
• Trois-Rivieres, QC

Denmark

• Aalborg
• Hillerød
• Roskilde

Finland

• Tampere
• Turku

France

• Auch
• Bordeaux
• Boulogne
• Castelnau Le Lez
• Cergy Pontoise
• Fleury-Merogis
• Herouville Saint Clair
• La Tronche
• Lyon
• Montpellier
• Nimes
• Paris
• Reims
• Rennes
• Saint Brieuc
• Saint Herblain
• Saint Ouen
• Villeurbanne

Germany

• Bad Hersfeld
• Bonn
• Dortmund
• München
• Stuttgart
• Villingen-Schwenningen

Italy

• Bologna
• Como
• Genova
• Lecco
• Modena
• Pavia
• Prato
• Venezia

Portugal

• Leiria

Spain

• Alicante
• Badalona
• Barcelona
• Bilbao
• Córdoba
• Leon
• Madrid
• Orense
• Santander
• Vigo

Switzerland

• Aarau

United Kingdom

• Belfast
• Canterbury
• Glasgow
• London
• Manchester