A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.
NCT ID: NCT00442702
Last Updated: 2011-12-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
228 participants
INTERVENTIONAL
2007-09-30
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mircera
Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
Mircera
Starting dose of 120, 200 and 360 micrograms administered by subcutaneous injection once a month.
Darbepoetin alfa
Participants continued to receive the same dose of darbepoetin alfa as before screening by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
Darbepoetin alfa
As prescribed, subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling specifications.
Interventions
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Mircera
Starting dose of 120, 200 and 360 micrograms administered by subcutaneous injection once a month.
Darbepoetin alfa
As prescribed, subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling specifications.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* chronic kidney disease, not requiring dialysis;
* receiving darbepoetin alfa maintenance therapy for \>=8 weeks before screening, and during screening/baseline period.
Exclusion Criteria
* transfusion of red blood cells within 8 weeks before screening, or during screening/baseline period;
* active malignant disease;
* previous treatment with Mircera.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Granada Hills, California, United States
Lauderdale Lakes, Florida, United States
Augusta, Georgia, United States
Mineola, New York, United States
Orchard Park, New York, United States
Raleigh, North Carolina, United States
Oregon City, Oregon, United States
Providence, Rhode Island, United States
Chattanooga, Tennessee, United States
Salem, Virginia, United States
Morgantown, West Virginia, United States
Adelaide, , Australia
Gosford, , Australia
Lismore, , Australia
Reservoir, , Australia
Richmond, , Australia
Aalst, , Belgium
Roeselare, , Belgium
Calgary, Alberta, Canada
St. John's, Newfoundland and Labrador, Canada
Kingston, Ontario, Canada
Mississauga, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Mariánské Lázně, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
La Tronche, , France
Nantes, , France
Orléans, , France
Paris, , France
Rennes, , France
Saint-Priest-en-Jarez, , France
Strasbourg, , France
Bad Hersfeld, , Germany
Bad König, , Germany
Berlin, , Germany
Bonn, , Germany
Coburg, , Germany
Demmin, , Germany
Dortmund, , Germany
München, , Germany
Baja, , Hungary
Budapest, , Hungary
Esztergom, , Hungary
Hódmezővásárhely, , Hungary
Kalocsa, , Hungary
Kecskemét, , Hungary
Szigetvár, , Hungary
Vác, , Hungary
Hadera, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Nahariya, , Israel
Rehovot, , Israel
Brescia, , Italy
Chieti, , Italy
Ferrara, , Italy
Genova, , Italy
La Spezia, , Italy
Lecco, , Italy
Lodi, , Italy
Palermo, , Italy
Pavia, , Italy
Prato, , Italy
Roma, , Italy
S Fermo Della Battaglia, , Italy
Gdansk, , Poland
Katowice, , Poland
Lodz, , Poland
Radom, , Poland
Rzeszów, , Poland
Sieradz, , Poland
Szczecin, , Poland
Warsaw, , Poland
A Coruña, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Ciudad Real, , Spain
L'Hospitalet de Llobregat, , Spain
Lleida, , Spain
Madrid, , Spain
Málaga, , Spain
Partida La Ceñuela. Torreviej, , Spain
Belfast, , United Kingdom
Birmingham, , United Kingdom
Bradford, , United Kingdom
Exeter, , United Kingdom
Countries
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References
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Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
Other Identifiers
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BH20051
Identifier Type: -
Identifier Source: org_study_id