A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.
NCT ID: NCT00454246
Last Updated: 2011-12-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
111 participants
INTERVENTIONAL
2007-04-30
2008-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
methoxy polyethylene glycol-epoetin beta
120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
methoxy polyethylene glycol-epoetin beta
Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in a 1-mL prefilled syringe containing 0.3 mL or 0.6 mL solution. The methoxy polyethylene glycol-epoetin beta injectable solution was formulated in sodium phosphate, sodium sulfate, mannitol, methionine and poloxamer 188, pH 6.2 and did not contain any preservative. Participants received methoxy polyethylene glycol-epoetin beta subcutaneous once a month.
Epoetin alfa
Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
epoetin alfa
Standard of care as prescribed, per individual participant, subcutaneous once per week. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Darbepoetin alfa
Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
darbepoetin alfa
Standard of care as prescribed, per individual participant, darbepoetin alfa subcutaneous once every two weeks. Subcutaneous injections were to be administered in the same part of the body (ie, thigh,abdomen or arm) throughout the study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
methoxy polyethylene glycol-epoetin beta
Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in a 1-mL prefilled syringe containing 0.3 mL or 0.6 mL solution. The methoxy polyethylene glycol-epoetin beta injectable solution was formulated in sodium phosphate, sodium sulfate, mannitol, methionine and poloxamer 188, pH 6.2 and did not contain any preservative. Participants received methoxy polyethylene glycol-epoetin beta subcutaneous once a month.
epoetin alfa
Standard of care as prescribed, per individual participant, subcutaneous once per week. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
darbepoetin alfa
Standard of care as prescribed, per individual participant, darbepoetin alfa subcutaneous once every two weeks. Subcutaneous injections were to be administered in the same part of the body (ie, thigh,abdomen or arm) throughout the study.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* chronic kidney disease stage IV not requiring dialysis;
* expected to initiate dialysis within 18 months;
* 15\<=Glomerular Filtration Rate (GFR)\<=29.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Mobile, Alabama, United States
Phoenix, Arizona, United States
El Dorado, Arkansas, United States
Hot Springs, Arkansas, United States
Bakersfield, California, United States
Glendale, California, United States
Granada Hills, California, United States
Los Angeles, California, United States
Orange, California, United States
Palm Springs, California, United States
Riverside, California, United States
San Diego, California, United States
Yuba City, California, United States
Colorado Springs, Colorado, United States
Lakewood, Colorado, United States
Stamford, Connecticut, United States
Miami, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Palm Beach Gardens, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Macon, Georgia, United States
Meridan, Idaho, United States
Evergreen Park, Illinois, United States
Fort Wayne, Indiana, United States
Wichita, Kansas, United States
Baton Rouge, Louisiana, United States
Shreveport, Louisiana, United States
Germantown, Maryland, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Detroit, Michigan, United States
Milwaukee, Michigan, United States
Royal Oak, Michigan, United States
Columbus, Mississippi, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Voorhees Township, New Jersey, United States
West Orange, New Jersey, United States
Brooklyn, New York, United States
Buffalo, New York, United States
Flushing, New York, United States
Great Neck, New York, United States
Mineola, New York, United States
Springfield Gardens, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Greenville, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Maimisburg, Ohio, United States
Toledo, Ohio, United States
Portland, Oregon, United States
Erie, Pennsylvania, United States
Lewistown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Columbia, South Carolina, United States
Greenville, South Carolina, United States
Orangeburg, South Carolina, United States
Chattanooga, Tennessee, United States
Dyersburg, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
Alexandria, Virginia, United States
Fairfax, Virginia, United States
Richmond, Virginia, United States
Salem, Virginia, United States
Bluefield, West Virginia, United States
Morgantown, West Virginia, United States
Appleton, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ML20337
Identifier Type: -
Identifier Source: org_study_id