Trial information
A Study of Once Monthly Intravenous or Subcutaneous Mircera in Patients With Chronic Kidney Disease on Hemodialysis.
Status: Not yet recruiting
Protocol number: ML21145
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, controlled, open label, French multicenter parallel group study to compare the hemoglobin maintenance with once monthly administration of Mircera versus epoetin beta or darbepoetin alfa in patients with chronic kidney disease on hemodialysis
Brief summary: This 2 arm study will compare the hemoglobin maintenance with once monthly Mircera administration versus epoetin beta or darbepoetin alfa in patients with chronic kidney disease on hemodialysis. Patients will be randomized to receive either monthly s.c. or i.v. Mircera (at a starting dose of 120 or 200 micrograms, calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered), or standard therapy (iv or sc epoetin beta once, twice or thrice weekly, or iv or sc darbepoetin alfa once a week or twice a week). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is 600.
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 maintaining average Hb concentration within target range (10-12g/dL) during evaluation period. Time frame: Weeks 16-24
Key secondary outcomes: 1. Mean change in Hb concentration between reference and evaluation period, and mean time spent in Hb range of 10-12g/dL during evaluation period. Time frame: Weeks 16-24
2. Dose adjustments, RBC transfusions, AEs. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- regular long term hemodialysis with same schedule for >=12 weeks;
- continuous iv or sc maintenance epoetin beta or darbepoetin alfa therapy, with the same dosing interval during the previous month, and no change in total weekly dose.
Exclusion criteria:
- transfusion of red blood cells during previous 2 months;
- significant acute or chronic bleeding;
- poorly controlled hypertension requiring hospitalization or interruption of epoetin beta/darbepoetin alfa treatment in previous 6 months;
- weekly dose of epoetin beta >16000 UI, or weekly dose of darbepoetin alfa >80 micrograms during previous month.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: August, 2008
Trial registration date: 07/15/2008
Date last updated: 9/29/2008
Link to trial result
This trial will be conducted at the following locations:
France
- Abbeville
- Albi Cedex 9
- Ales
- Angers
- Annonay
- Antony
- Aubagne
- Avignon
- Bagnols Sur Ceze
- Besancon
- Beuvry
- Beziers
- Blois
- Bois Bernard
- Bordeaux
- Brest
- Cabestany
- Caen
- Cannes
- Carcassonne
- Carpentras
- Castelnau Le Lez
- Cergy Pontoise
- Chamalieres
- Charleville Mezieres
- Chateauroux
- Clermont-Ferrand
- Colomiers
- Compiegne
- Creteil
- Dijon
- Draguignan
- Evry
- Fleury-Merogis
- Gradignan
- La Rochelle
- La Tronche
- Le Mans
- Le Petit Quevilly
- Le Port Marly
- Lille
- Lyon
- Manosque
- Marseille
- Meaux
- Metz
- Montpellier
- Mulhouse Cedex 1
- Nantes
- Paris
- Perpignan
- Pierre Benite
- Poitiers
- Quincy Sous Senart
- Reims
- Rueil Malmaison
- Saint Herblain
- Saint Ouen
- Saint Pierre
- Saintes
- Saint-Maurice
- St Benoit
- St Brieuc Cedex 1
- St Priest En Jarez
- St Quentin
- Strasbourg
- Tassin
- Toulouse
- Vandoeuvre Les Nancy
- Vandoeuvre-Les-Nancy
- Vannes
- Vernouillet
- Vienne
- Villeurbanne
