Clinical trial NCT00454246: A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.
Official title: A Randomized, Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Control in Patients Transitioning From Chronic Kidney Disease Stage 4 Through Dialysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-03-30
Enrollment: 111
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 methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through dialysis. Patients will be randomized either to receive Mircera or to remain on their existing therapy; the initial monthly dose of subcutaneous (sc) Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation of dialysis, patients in the Mircera group will receive monthly intravenous (iv) Mircera at a starting dose based on their previous (sc) dose, and those in the control group will receive weekly (iv) epoetin alfa. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic kidney disease stage IV not requiring dialysis;
* expected to initiate dialysis within 18 months;
* 15\<=Glomerular Filtration Rate (GFR)\<=29.

Exclusion Criteria:

* failing renal allograft in place;
* acute or chronic bleeding within 8 weeks prior to screening;
* transfusion of red blood cells within 8 weeks prior to screening;
* poorly controlled hypertension;
* immunosuppressive therapy in the 12 weeks prior to screening.

Primary outcomes:
measure: Percentage of Patients Able to Maintain Hemoglobin (Hb) Within 10-12 g/dL
timeFrame: 6-7 months post initiation of dialysis
Secondary outcomes:
measure: Dose Adjustments
timeFrame: 5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end.
measure: Number of Participants Assessed for AEs and SAEs
timeFrame: First dose of medication through 15 days post last dose (up to 8 months)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: El Dorado
country: United States
state: Arkansas
city: Hot Springs
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Glendale
country: United States
state: California
city: Granada Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: Yuba City
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Lakewood
country: United States
state: Colorado
city: Stamford
country: United States
state: Connecticut
city: Miami
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Palm Beach Gardens
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Meridan
country: United States
state: Idaho
city: Evergreen Park
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Baton Rouge
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Germantown
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Milwaukee
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Columbus
country: United States
state: Mississippi
city: St Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Voorhees
country: United States
state: New Jersey
city: West Orange
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Buffalo
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: Great Neck
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: Springfield Gardens
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Maimisburg
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: Lewistown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Columbia
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Orangeburg
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Dyersburg
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Alexandria
country: United States
state: Virginia
city: Fairfax
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Salem
country: United States
state: Virginia
city: Bluefield
country: United States
state: West Virginia
city: Morgantown
country: United States
state: West Virginia
city: Appleton
country: United States
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: