Clinical trial NCT00422513: A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
Official title: A Randomized, Open-label Study Comparing the Pharmacoeconomic (Time and Motion) Benefit of Mircera and Epoetin Alfa in Patients With Chronic Kidney Disease (Stage V) on Dialysis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-01-17
Enrollment: 260
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 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. 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;
* CKD (stage V) on outpatient hemodialysis therapy for \>= 3 months;
* CKD-related anemia treated with epoetin alfa iv 3x/week for \>= 3 months;
* average hemoglobin (Hb) 10-12 g/dL over last 3 months.

Exclusion Criteria:

* failed renal transplant within 12 months prior to screening;
* poorly controlled hypertension;
* previous treatment with Mircera.

Primary outcomes:
measure: Time Spent on Anemia Treatment Over Evaluation Period
timeFrame: Months 5-7
measure: Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period
timeFrame: Baseline, Months 5-7
Secondary outcomes:
measure: Number of Participants Assessed for AEs
timeFrame: Month 1 to 15 day follow up post month 7
measure: The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants
timeFrame: Baseline, Month 1 to Month 7
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Rainbow City
country: United States
state: Alabama
city: Hot Springs
country: United States
state: Arizona
city: Fairfield
country: United States
state: California
city: Los Alamitos
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mountain View
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: Simi Valley
country: United States
state: California
city: Whittier
country: United States
state: California
city: Lakewood
country: United States
state: Colorado
city: Brandon
country: United States
state: Florida
city: Hudson
country: United States
state: Florida
city: Lauderdale Lakes
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Palm Beach Gardens
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Gurnee
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Detroit
country: United States
state: Michigan
city: Pontiac
country: United States
state: Michigan
city: Sparks
country: United States
state: Nevada
city: New Brunswick
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: Brooklyn Center
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: Orchard Park
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Lancaster
country: United States
state: Pennsylvania
city: Lewistown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: West Homestead
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Orangeburg
country: United States
state: South Carolina
city: Corpus Christi
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Chesapeake
country: United States
state: Virginia
city: Fairfax
country: United States
state: Virginia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: