Clinical trial NCT00077610: A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients
Official title: A Randomized, Controlled, Open-label, Multi-center, Parallel-group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Intravenously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2004-02-13
Enrollment: 673
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 Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. 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 renal anemia;
* on dialysis therapy for at least 12 weeks before screening;
* receiving IV 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: Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period
timeFrame: Baseline, Week 29 to Week 36
Secondary outcomes:
measure: Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration.
timeFrame: Baseline, Week 29 to Week 36
measure: The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods
timeFrame: Week 1 to Week 36
measure: Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC)
timeFrame: Up to Week 53
measure: Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes
timeFrame: Up to Week 53
measure: Mean Change in Blood Pressure From Baseline at Week 36 and Week 52
timeFrame: Baseline, Week 36 and Week 52
measure: Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52
timeFrame: Baseline, Week 36 and Week 52
measure: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Death
timeFrame: Upto Week 53
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Encino
country: United States
state: California
city: Irvine
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Monterey Park
country: United States
state: California
city: Riverside
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Jose
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Lakewood
country: United States
state: Colorado
city: Ocala
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Louisville
country: United States
state: Kentucky
city: Covington
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Brooklyn Center
country: United States
state: Minnesota
city: Paterson
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Bronx
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Great Neck
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Erie
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Orangeburg
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Fairfax
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Marshfield
country: United States
state: Wisconsin
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Kingston
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Mississauga
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: Saskatoon
country: Canada
state: Saskatchewan
city: Aubervilliers
country: France
city: Bordeaux
country: France
city: La Tronche
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Toulouse
country: France
city: Dortmund
country: Germany
city: Ellwangen
country: Germany
city: München
country: Germany
city: Nürnberg
country: Germany
city: Stuttgart
country: Germany
city: Wiesbaden
country: Germany
city: Wiesloch
country: Germany
city: Como
country: Italy
city: Lecco
country: Italy
city: Lodi
country: Italy
city: Milano
country: Italy
city: Pavia
country: Italy
city: Bergen
country: Norway
city: Levanger
country: Norway
city: Lillehammer
country: Norway
city: Trondheim
country: Norway
city: Barcelona
country: Spain
city: La Coruna
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Sevilla
country: Spain
city: Lausanne
country: Switzerland
city: Lausanne
country: Switzerland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Levin NW, Fishbane S, Canedo FV, Zeig S, Nassar GM, Moran JE, Villa G, Beyer U, Oguey D; MAXIMA study investigators. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA). Lancet. 2007 Oct 20;370(9596):1415-21. doi: 10.1016/S0140-6736(07)61599-2.