Study Stopped
Strategic decision unrelated to safety or efficacy
A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.
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
1 other identifier
interventional
111
1 country
78
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2007
Shorter than P25 for phase_3
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2007
CompletedFirst Posted
Study publicly available on registry
March 30, 2007
CompletedStudy Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
December 16, 2011
CompletedDecember 16, 2011
November 1, 2011
10 months
March 29, 2007
March 29, 2011
November 14, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients Able to Maintain Hemoglobin (Hb) Within 10-12 g/dL
Efficacy analyses were not performed.
6-7 months post initiation of dialysis
Secondary Outcomes (2)
Dose Adjustments
5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end.
Number of Participants Assessed for AEs and SAEs
First dose of medication through 15 days post last dose (up to 8 months)
Study Arms (3)
methoxy polyethylene glycol-epoetin beta
EXPERIMENTAL120-360 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.
Epoetin alfa
ACTIVE COMPARATORPatients 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.
Darbepoetin alfa
ACTIVE COMPARATORPatients 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- chronic kidney disease stage IV not requiring dialysis;
- expected to initiate dialysis within 18 months;
- \<=Glomerular Filtration Rate (GFR)\<=29.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Mobile, Alabama, United States
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Phoenix, Arizona, United States
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El Dorado, Arkansas, United States
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Hot Springs, Arkansas, United States
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Bakersfield, California, United States
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Glendale, California, United States
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Granada Hills, California, 91344, United States
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Los Angeles, California, United States
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Orange, California, United States
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Palm Springs, California, United States
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Riverside, California, United States
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San Diego, California, United States
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Yuba City, California, United States
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Colorado Springs, Colorado, United States
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Lakewood, Colorado, United States
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Stamford, Connecticut, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Palm Beach Gardens, Florida, United States
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Pembroke Pines, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Macon, Georgia, United States
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Meridan, Idaho, 83642, United States
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Evergreen Park, Illinois, United States
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Fort Wayne, Indiana, United States
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Wichita, Kansas, United States
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Baton Rouge, Louisiana, United States
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Shreveport, Louisiana, United States
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Germantown, Maryland, United States
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Detroit, Michigan, United States
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Milwaukee, Michigan, United States
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Royal Oak, Michigan, United States
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Columbus, Mississippi, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Voorhees Township, New Jersey, United States
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West Orange, New Jersey, 07052, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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Flushing, New York, United States
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Great Neck, New York, United States
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Mineola, New York, United States
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Springfield Gardens, New York, United States
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Syracuse, New York, United States
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The Bronx, New York, United States
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Durham, North Carolina, United States
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Greenville, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Maimisburg, Ohio, United States
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Toledo, Ohio, United States
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Portland, Oregon, United States
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Erie, Pennsylvania, United States
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Lewistown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Orangeburg, South Carolina, United States
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Chattanooga, Tennessee, United States
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Dyersburg, Tennessee, United States
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Houston, Texas, 77024, United States
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San Antonio, Texas, United States
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Temple, Texas, United States
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Alexandria, Virginia, United States
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Fairfax, Virginia, United States
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Richmond, Virginia, United States
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Salem, Virginia, United States
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Bluefield, West Virginia, United States
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Morgantown, West Virginia, United States
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Appleton, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2007
First Posted
March 30, 2007
Study Start
April 1, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
December 16, 2011
Results First Posted
December 16, 2011
Record last verified: 2011-11