Clinical trial NCT00081471: A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis
Official title: A Randomized, Open-label Study of the Effect of Subcutaneous Mircera on Hemoglobin Level/Correction in Non-dialysis Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2004-04-16
Enrollment: 324
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 study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic kidney disease;
* anemia;
* not on dialysis therapy;
* not receiving epoetin.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* administration of another investigational drug within 4 weeks before screening, or during the study period.

Primary outcomes:
measure: Hemoglobin response rate
timeFrame: Weeks 1-28
Secondary outcomes:
measure: Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values\n\n
timeFrame: Throughout study
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Mather
country: United States
state: California
city: Stanford
country: United States
state: California
city: Stamford
country: United States
state: Connecticut
city: Bay Pines
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Shreveport
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Flushing
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Allentown
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Salem
country: United States
state: Virginia
city: Morgantown
country: United States
state: West Virginia
city: Clayton
country: Australia
city: Liverpool
country: Australia
city: Parkville
country: Australia
city: Perth
country: Australia
city: Antwerpen
country: Belgium
city: Leuven
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Kamloops
country: Canada
state: British Columbia
city: New Westminster
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Kitchener
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Scarborough
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Angers
country: France
city: Besancon
country: France
city: Chartres
country: France
city: Colmar
country: France
city: Lille
country: France
city: Lyon
country: France
city: Nantes
country: France
city: Paris
country: France
city: Paris
country: France
city: Perpignan
country: France
city: Salouel
country: France
city: Toulouse
country: France
city: Vandoeuvre-les-nancy
country: France
city: Aschaffenburg
country: Germany
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Dortmund
country: Germany
city: Düsseldorf
country: Germany
city: Tübingen
country: Germany
city: Alexandroupolis
country: Greece
city: Athens
country: Greece
city: Ioannina
country: Greece
city: Piraeus
country: Greece
city: Thessaloniki
country: Greece
city: Cagliari
country: Italy
city: Cuneo
country: Italy
city: Genova
country: Italy
city: Lecco
country: Italy
city: Lodi
country: Italy
city: Modena
country: Italy
city: Napoli
country: Italy
city: Padova
country: Italy
city: Pavia
country: Italy
city: Prato
country: Italy
city: Reggio Calabria
country: Italy
city: Roma
country: Italy
city: Amersfoort
country: Netherlands
city: Heerlen
country: Netherlands
city: San Juan
country: Puerto Rico
city: Almería
country: Spain
city: Barcelona
country: Spain
city: Lerida
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Palma de Mallorca
country: Spain
city: Valencia
country: Spain
city: Boras
country: Sweden
city: Umea
country: Sweden
city: Birmingham
country: United Kingdom
city: Carshalton
country: United Kingdom
city: Leicester
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: