Clinical trial NCT00077623: A Study of Subcutaneous 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 Subcutaneously 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: 572
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 (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc 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 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: Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods
timeFrame: Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36)
Secondary outcomes:
measure: Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration
timeFrame: Evaluation period (Week 29 to Week 36)
measure: Number of Participants With Red Blood Cell Transfusions
timeFrame: Up to Week 36
measure: Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths
timeFrame: Up to week 52
measure: Number of Participants With Marked Laboratory Abnormalities
timeFrame: Up to week 52
measure: Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants
timeFrame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
measure: Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants
timeFrame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
measure: Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants
timeFrame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
measure: Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants
timeFrame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Other outcomes:
Locations:
city: Hot Springs
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Riverside
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Jose
country: United States
state: California
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: Raleigh
country: United States
state: North Carolina
city: Winston-salem
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Morgantown
country: United States
state: West Virginia
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Hasselt
country: Belgium
city: Curitiba
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Brno
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Plzen
country: Czech Republic
city: Odense
country: Denmark
city: HUS
country: Finland
city: Tampere
country: Finland
city: Turku
country: Finland
city: Bayonne
country: France
city: Boulogne
country: France
city: Cabestany
country: France
city: Caen
country: France
city: Limoges
country: France
city: Nimes
country: France
city: Pantin
country: France
city: Poitiers
country: France
city: Saint-germain-en-laye
country: France
city: St Priest En Jarez
country: France
city: Thionville
country: France
city: Tours
country: France
city: Bad Hersfeld
country: Germany
city: Berlin
country: Germany
city: Kaiserslautern
country: Germany
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Miskolc
country: Hungary
city: Pecs
country: Hungary
city: Cremona
country: Italy
city: Lecco
country: Italy
city: Mestre
country: Italy
city: Modena
country: Italy
city: Prato
country: Italy
city: Venezia
country: Italy
city: Cuernavaca
country: Mexico
city: Mexico City
country: Mexico
city: Christchurch
country: New Zealand
city: Wellington
country: New Zealand
city: Panama City
country: Panama
city: Gdansk
country: Poland
city: Kielce
country: Poland
city: Krakow
country: Poland
city: Wroclaw
country: Poland
city: Ponce
country: Puerto Rico
city: Durban
country: South Africa
city: Alcorcon
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Palma de Mallorca
country: Spain
city: Pamplona
country: Spain
city: Santiago de Compostela
country: Spain
city: Huddinge
country: Sweden
city: Karlstad
country: Sweden
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Phitsanulok
country: Thailand
city: Belfast
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Dundee
country: United Kingdom
city: Exeter
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: