Clinical trial NCT00081484: A Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients
Official title: A Randomized, Open-label Study of the Effect of Maintenance Mircera Administered With Pre-filled Syringes on Hemoglobin Levels in Anemic 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: 336
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 intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. 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;
* on dialysis therapy for at least 12 weeks before screening;
* receiving iv or sc epoetin for at least 8 weeks before screening.

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: Change in hemoglobin concentration
timeFrame: Weeks 1-36
Secondary outcomes:
measure: Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration
timeFrame: Weeks 29-36
measure: RBC transfusions
timeFrame: Weeks 1-36
measure: AEs, laboratory parameters, vital signs
timeFrame: Throughout study
Other outcomes:
Locations:
city: Covina
country: United States
state: California
city: Los Alamitos
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Tampa
country: United States
state: Florida
city: Honolulu
country: United States
state: Hawaii
city: South Holland
country: United States
state: Illinois
city: Baton Rouge
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Kalamazoo
country: United States
state: Michigan
city: Columbus
country: United States
state: Mississippi
city: Tupelo
country: United States
state: Mississippi
city: St. Louis
country: United States
state: Missouri
city: Hackensack
country: United States
state: New Jersey
city: Flushing
country: United States
state: New York
city: New York
country: United States
state: New York
city: Orchard Park
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Oregon City
country: United States
state: Oregon
city: Erie
country: United States
state: Pennsylvania
city: Lewistown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Charlottesville
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Greenfield Park
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Aix En Provence
country: France
city: Chambery
country: France
city: Hyeres
country: France
city: Le Kremlin-bicetre
country: France
city: Nantes
country: France
city: Paris
country: France
city: Rouen
country: France
city: Erlangen
country: Germany
city: München
country: Germany
city: Nürnberg
country: Germany
city: Como
country: Italy
city: Modena
country: Italy
city: Pavia
country: Italy
city: Rzeszow
country: Poland
city: Warszawa
country: Poland
city: Carnaxide
country: Portugal
city: Porto
country: Portugal
city: Setubal
country: Portugal
city: Ponce
country: Puerto Rico
city: San Juan
country: Puerto Rico
city: Alicante
country: Spain
city: Madrid
country: Spain
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Glasgow
country: United Kingdom
city: Hertford
country: United Kingdom
city: London
country: United Kingdom
city: Salford
country: United Kingdom
city: Swansea
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: