Clinical trial NCT00077597: A Study of Mircera for the Treatment of Anemia in Dialysis Patients
Official title: A Randomized, Open-label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in 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: 2004-02-12
Enrollment: 182
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 Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently 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 renal anemia;
* dialysis therapy for at least 2 weeks before screening.

Exclusion Criteria:

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

Primary outcomes:
measure: Hemoglobin response rate
timeFrame: Weeks 1-24
Secondary outcomes:
measure: Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values\n
timeFrame: Throughout study
Other outcomes:
Locations:
city: Davis
country: United States
state: California
city: Lakewood
country: United States
state: Colorado
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: New Orleans
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Toledo
country: United States
state: Ohio
city: Houston
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Norfolk
country: United States
state: Virginia
city: Curitiba
country: Brazil
city: Ribeirão Preto
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Kingston
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Liberec
country: Czech Republic
city: Praha
country: Czech Republic
city: Usti Nad Labem
country: Czech Republic
city: Alexandroupolis
country: Greece
city: Larissa
country: Greece
city: Nikea
country: Greece
city: Thessaloniki
country: Greece
city: Bergen
country: Norway
city: Oslo
country: Norway
city: Gdansk
country: Poland
city: Gdynia
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Poznan
country: Poland
city: Szczecin
country: Poland
city: Wolomin
country: Poland
city: Wroclaw
country: Poland
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Johannesburg
country: South Africa
city: Soweto
country: South Africa
city: Bilbao
country: Spain
city: Santander
country: Spain
city: Karlstad
country: Sweden
city: Lausanne
country: Switzerland
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Chonburi
country: Thailand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Klinger M, Arias M, Vargemezis V, Besarab A, Sulowicz W, Gerntholtz T, Ciechanowski K, Dougherty FC, Beyer U. Efficacy of intravenous methoxy polyethylene glycol-epoetin beta administered every 2 weeks compared with epoetin administered 3 times weekly in patients treated by hemodialysis or peritoneal dialysis: a randomized trial. Am J Kidney Dis. 2007 Dec;50(6):989-1000. doi: 10.1053/j.ajkd.2007.08.013.