Clinical trial NCT00717821: A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis.
Official title: A Randomised, Controlled, Open-label, French Multicenter Parallel Group Study to Compare the Maintenance of Haemoglobin Level With Once Monthly Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) Versus Epoetin Beta or Darbepoetin Alfa in Patients With Chronic Kidney Disease on Haemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-07-18
Enrollment: 421
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm study will compare the hemoglobin maintenance with once monthly methoxy polyethylene glycol-epoetin beta (Mircera) administration versus epoetin beta or darbepoetin alfa in participants with chronic kidney disease on hemodialysis. Participants will be randomized to receive either monthly intravenous (IV) or subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (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).


Eligibility criteria: Inclusion Criteria:

* regular long term hemodialysis with same schedule for greater than or equal to (\>=) 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 greater than (\>) 16000 international units (IU), or weekly dose of darbepoetin alfa \>80 micrograms during previous month

Primary outcomes:
measure: Percentage of patients maintaining average Hb concentration within target range (10-12g/dL) during evaluation period.
timeFrame: Weeks 16-24
Secondary outcomes:
measure: Mean change in Hb concentration between reference and evaluation period, and mean time spent in Hb range of 10-12g/dL during evaluation period.
timeFrame: Weeks 16-24
measure: Dose adjustments, RBC transfusions, AEs.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Abbeville
country: France
city: Albi
country: France
city: Amilly
country: France
city: Angers
country: France
city: Annonay
country: France
city: Antony
country: France
city: Aubagne
country: France
city: Aulnay Sous Bois
country: France
city: Avignon
country: France
city: Bagnols Sur Ceze
country: France
city: Beauvais
country: France
city: Besancon
country: France
city: Beuvry
country: France
city: Beziers
country: France
city: Bois Bernard
country: France
city: Bordeaux
country: France
city: Brest
country: France
city: Cabestany
country: France
city: Caen
country: France
city: Cannes
country: France
city: Carpentras
country: France
city: Castelnau le Lez
country: France
city: Chamalieres
country: France
city: Charleville Mezieres
country: France
city: Clermont-ferrand
country: France
city: Colmar
country: France
city: Compiegne
country: France
city: Creil
country: France
city: Creteil
country: France
city: Dijon
country: France
city: Draguignan
country: France
city: Evry
country: France
city: Fleury Merogis
country: France
city: Hyeres
country: France
city: La Chaussee St Victor
country: France
city: La Rochelle
country: France
city: La Tronche
country: France
city: Le Mans
country: France
city: Le Petit Quevilly
country: France
city: Le Port Marly
country: France
city: Lille
country: France
city: Lille
country: France
city: Lliie
country: France
city: Lyon
country: France
city: Manosque
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Meaux
country: France
city: Metz
country: France
city: Montpellier
country: France
city: Mulhouse
country: France
city: Muret
country: France
city: Nantes
country: France
city: Orleans
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Perpignan
country: France
city: Pessac
country: France
city: Pierre Benite
country: France
city: Poissy
country: France
city: Poitiers
country: France
city: Quincy Sous Senart
country: France
city: Reims
country: France
city: Rouen
country: France
city: Rueil Malmaison
country: France
city: Saint Ouen
country: France
city: Saintes
country: France
city: St Benoit
country: France
city: St Brieuc
country: France
city: St Denis
country: France
city: St Maurice
country: France
city: St Ouen
country: France
city: St Pierre
country: France
city: St Priest En Jarez
country: France
city: St Quentin
country: France
city: Strasbourg
country: France
city: Tassin
country: France
city: Toulon
country: France
city: Toulouse
country: France
city: Toulouse
country: France
city: Trappes
country: France
city: Vandoeuvre-les-nancy
country: France
city: Vannes
country: France
city: Vienne
country: France
city: Villeurbanne
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.