- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00442702
A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.
December 13, 2011 updated by: Hoffmann-La Roche
An Open-label, Randomized, Multi-center, Parallel Group Non-inferiority Study of Subcutaneous Injections of RO0503821 Given Once Monthly vs. Darbepoetin Alfa Given According to Local Label in Patients With Chronic Kidney Disease Who Are Not on Dialysis.
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy.
Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera.
The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study Overview
Study Type
Interventional
Enrollment (Actual)
228
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Adelaide, Australia, SA 5000
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Gosford, Australia, 2250
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Lismore, Australia, 2480
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Reservoir, Australia, 3073
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Richmond, Australia, 3121
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Aalst, Belgium, 9300
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Roeselare, Belgium, 8800
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
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Newfoundland and Labrador
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St John's, Newfoundland and Labrador, Canada, A1B 3V6
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Ontario
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Kingston, Ontario, Canada, K7L 3N6
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Mississauga, Ontario, Canada, L5M 2V8
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Toronto, Ontario, Canada, M5G 2C4
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Toronto, Ontario, Canada, M9N 1N8
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Quebec
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Montreal, Quebec, Canada, H2X 3J4
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Marianske Lazne, Czech Republic, 35301
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Praha, Czech Republic, 14021
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Praha 2, Czech Republic, 128 08
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Praha 4, Czech Republic, 14200
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La Tronche, France, 38700
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Nantes, France, 44035
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Orleans, France, 45100
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Paris, France, 75475
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Rennes, France, 35033
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St Priest En Jarez, France, 42277
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Strasbourg, France, 67091
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Bad Hersfeld, Germany, 36251
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Bad König, Germany, 64732
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Berlin, Germany, 13353
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Bonn, Germany, 53127
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Coburg, Germany, 96450
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Demmin, Germany, 17109
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Dortmund, Germany, 44263
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München, Germany, 80331
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Baja, Hungary, 6500
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Budapest, Hungary, 1071
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Esztergom, Hungary, 2500
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Hodmezovasarhely, Hungary, 6800
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Kalocsa, Hungary, 6300
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Kecskemet, Hungary, 6001
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Szigetvar, Hungary, 7390
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VAC, Hungary, 2600
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Hadera, Israel, 38100
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Jerusalem, Israel, 91031
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Kfar Saba, Israel, 44281
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Nahariya, Israel, 22100
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Rehovot, Israel, 76100
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Brescia, Italy, 25123
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Chieti, Italy, 66013
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Ferrara, Italy, 44100
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Genova, Italy, 16132
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La Spezia, Italy, 19124
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Lecco, Italy, 23900
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Lodi, Italy, 26900
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Palermo, Italy, 90127
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Pavia, Italy, 27100
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Prato, Italy, 50047
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Roma, Italy, 00186
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S Fermo Della Battaglia, Italy, 22020
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Gdansk, Poland, 80-211
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Katowice, Poland, 40-027
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Lodz, Poland, 90-153
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Radom, Poland, 20-610
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Rzeszow, Poland, 35-055
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Sieradz, Poland, 98-200
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Szczecin, Poland, 70-111
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Warszawa, Poland, 02-006
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Barcelona, Spain, 08036
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Barcelona, Spain, 08035
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Barcelona, Spain, 08025
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Ciudad Real, Spain, 13005
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Hospitalet de Llobregat, Spain, 08907
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La Coruna, Spain, 15006
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Lerida, Spain, 25198
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Madrid, Spain, 28007
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Málaga, Spain, 29010
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Partida La Ceñuela. Torreviej, Spain, 03186
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Belfast, United Kingdom, BT9 7LJ
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Birmingham, United Kingdom, B15 2TH
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Bradford, United Kingdom, BD5 0NA
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Exeter, United Kingdom, EX2 5DW
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California
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Granada Hills, California, United States, 91344
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Florida
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Lauderdale Lakes, Florida, United States, 33313
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Georgia
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Augusta, Georgia, United States, 30309
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New York
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Mineola, New York, United States, 11501
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Orchard Park, New York, United States, 14127
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North Carolina
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Raleigh, North Carolina, United States, 27609
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Oregon
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Oregon City, Oregon, United States, 97045
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Rhode Island
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Providence, Rhode Island, United States, 02903
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Tennessee
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Chattanooga, Tennessee, United States, 37404
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Virginia
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Salem, Virginia, United States, 24153
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West Virginia
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Morgantown, West Virginia, United States, 26506
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients, >=18 years of age;
- chronic kidney disease, not requiring dialysis;
- receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and during screening/baseline period.
Exclusion Criteria:
- overt gastrointestinal bleeding within 8 weeks before screening, or during screening/baseline period;
- transfusion of red blood cells within 8 weeks before screening, or during screening/baseline period;
- active malignant disease;
- previous treatment with Mircera.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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Starting dose of 120, 200 and 360 micrograms administered by subcutaneous injection once a month.
Other Names:
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Active Comparator: 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).
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As prescribed, subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling specifications.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period
Time Frame: Baseline (measurements at Week -4, Week -2 and Day 1) and Evaluation Period (Months 8 and 9; measurements twice a month and at the final visit).
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A time adjusted average baseline hemoglobin (Hb) concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period.
The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the two month evaluation period.
The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb from the evaluation period Hb.
All blood samples for Hb measurements were taken prior to study drug administration.
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Baseline (measurements at Week -4, Week -2 and Day 1) and Evaluation Period (Months 8 and 9; measurements twice a month and at the final visit).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Hemoglobin Concentration From Baseline Over Time
Time Frame: From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.
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From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.
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Number of Participants With Red Blood Cell (RBC) Transfusions
Time Frame: From randomization to Month 9
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Red blood cell (RBC) transfusions could be given during the treatment period in case of medical need, i.e., in severely anemic patients with recognized symptoms or signs of anemia (e.g., in patients with acute blood loss, with severe angina, or whose Hemoglobin decreased to critical levels).
The number of participants who had at least one red blood cell transfusion during the entire study, during the Titration Period and during the Evaluation Period is presented.
Participants who received more than one transfusion within a defined period are only counted once.
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From randomization to Month 9
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Participants With Adverse Events
Time Frame: Randomization to Month 10 (final visit)
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Adverse events were collected during the treatment period (from the first treatment dose) up to 30 days after last dose or at least until the date of last contact if the date of last contact occurred after the specified 30 day period.
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Randomization to Month 10 (final visit)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
March 1, 2007
First Submitted That Met QC Criteria
March 1, 2007
First Posted (Estimate)
March 2, 2007
Study Record Updates
Last Update Posted (Estimate)
December 19, 2011
Last Update Submitted That Met QC Criteria
December 13, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BH20051
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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