Clinical trial NCT00394953: A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients
Official title: A Randomized, Controlled, Open Label, Multicenter, Parallel-group 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-11-02
Enrollment: 490
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 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 (CKD) who are on hemodialysis. Eligible patients receiving once-weekly intravenous (IV) 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.


Eligibility criteria: 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;

Primary outcomes:
measure: Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period
timeFrame: Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53)
Secondary outcomes:
measure: Mean Percentage Change in MIRCERA and Darbepoetin Alpha Dose Over Time
timeFrame: Week 27 to Month 12
measure: Number of Participants With Marked Laboratory Abnormality Over Time
timeFrame: Up to Week 53
measure: Median Blood Pressure Over Time
timeFrame: Baseline (Week -4 to Week -1), Week 28, and Week 52
measure: Mean Pulse Rate Over Time
timeFrame: Baseline (Week -4 to Week -1), Week 28, and Week 52
measure: Number of Participants With Any Adverse Events, Serious Adverse Events, and Deaths
timeFrame: From screening to Week 56
Other outcomes:
Locations:
city: Adelaide
country: Australia
city: Clayton
country: Australia
city: Gosford
country: Australia
city: Parkville
country: Australia
city: Woolloongabba
country: Australia
city: Linz
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Aalst
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Roeselare
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Hamilton
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Greenfield Park
country: Canada
state: Quebec
city: Trois-rivieres
country: Canada
state: Quebec
city: Aalborg
country: Denmark
city: Hillerød
country: Denmark
city: Roskilde
country: Denmark
city: Tampere
country: Finland
city: Turku
country: Finland
city: Auch
country: France
city: Bordeaux
country: France
city: Boulogne
country: France
city: Castelnau Le Lez
country: France
city: Cergy Pontoise
country: France
city: Chamalieres
country: France
city: Dijon
country: France
city: Fleury-merogis
country: France
city: Herouville Saint Clair
country: France
city: La Tronche
country: France
city: Lyon
country: France
city: Montpellier
country: France
city: Nimes
country: France
city: Paris
country: France
city: Paris
country: France
city: Reims
country: France
city: Rennes
country: France
city: Saint Herblain
country: France
city: Saint Ouen
country: France
city: St Brieuc
country: France
city: Villeurbanne
country: France
city: Bad Hersfeld
country: Germany
city: Bonn
country: Germany
city: Dortmund
country: Germany
city: München
country: Germany
city: Stuttgart
country: Germany
city: Villingen-schwenningen
country: Germany
city: Bologna
country: Italy
city: Como
country: Italy
city: Genova
country: Italy
city: Lecco
country: Italy
city: Modena
country: Italy
city: Pavia
country: Italy
city: Prato
country: Italy
city: Venezia
country: Italy
city: Amsterdam
country: Netherlands
city: Dordrecht
country: Netherlands
city: Leiria
country: Portugal
city: Alicante
country: Spain
city: Badalona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Bilbao
country: Spain
city: Córdoba
country: Spain
city: Leon
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Orense
country: Spain
city: Santander
country: Spain
city: Vigo
country: Spain
city: Vigo
country: Spain
city: Aarau
country: Switzerland
city: Lausanne
country: Switzerland
city: Belfast
country: United Kingdom
city: Canterbury
country: United Kingdom
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Truro
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Carrera F, Lok CE, de Francisco A, Locatelli F, Mann JF, Canaud B, Kerr PG, Macdougall IC, Besarab A, Villa G, Kazes I, Van Vlem B, Jolly S, Beyer U, Dougherty FC; PATRONUS Investigators. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Nephrol Dial Transplant. 2010 Dec;25(12):4009-17. doi: 10.1093/ndt/gfq305. Epub 2010 Jun 3.