A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.
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.
1 other identifier
interventional
228
13 countries
91
Brief Summary
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.
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 Sep 2007
Typical duration for phase_3
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2007
CompletedFirst Posted
Study publicly available on registry
March 2, 2007
CompletedStudy Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
October 3, 2011
CompletedDecember 19, 2011
December 1, 2011
2.9 years
March 1, 2007
August 29, 2011
December 13, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period
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.
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).
Secondary Outcomes (3)
Change in Hemoglobin Concentration From Baseline Over Time
From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.
Number of Participants With Red Blood Cell (RBC) Transfusions
From randomization to Month 9
Participants With Adverse Events
Randomization to Month 10 (final visit)
Study Arms (2)
Mircera
EXPERIMENTALParticipants 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.
Darbepoetin alfa
ACTIVE COMPARATORParticipants 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).
Interventions
Starting dose of 120, 200 and 360 micrograms administered by subcutaneous injection once a month.
As prescribed, subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling specifications.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (91)
Unknown Facility
Granada Hills, California, 91344, United States
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Lauderdale Lakes, Florida, 33313, United States
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Augusta, Georgia, 30309, United States
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Mineola, New York, 11501, United States
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Orchard Park, New York, 14127, United States
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Raleigh, North Carolina, 27609, United States
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Oregon City, Oregon, 97045, United States
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Providence, Rhode Island, 02903, United States
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Chattanooga, Tennessee, 37404, United States
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Salem, Virginia, 24153, United States
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Morgantown, West Virginia, 26506, United States
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Adelaide, SA 5000, Australia
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Gosford, 2250, Australia
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Lismore, 2480, Australia
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Reservoir, 3073, Australia
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Richmond, 3121, Australia
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Aalst, 9300, Belgium
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Roeselare, 8800, Belgium
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Calgary, Alberta, T2N 2T9, Canada
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St. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Kingston, Ontario, K7L 3N6, Canada
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Mississauga, Ontario, L5M 2V8, Canada
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Toronto, Ontario, M5G 2C4, Canada
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Toronto, Ontario, M9N 1N8, Canada
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Montreal, Quebec, H2X 3J4, Canada
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Mariánské Lázně, 35301, Czechia
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Prague, 128 08, Czechia
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Prague, 14021, Czechia
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Prague, 14200, Czechia
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La Tronche, 38700, France
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Nantes, 44035, France
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Orléans, 45100, France
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Paris, 75475, France
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Rennes, 35033, France
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Saint-Priest-en-Jarez, 42277, France
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Strasbourg, 67091, France
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Bad Hersfeld, 36251, Germany
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Bad König, 64732, Germany
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Berlin, 13353, Germany
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Bonn, 53127, Germany
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Coburg, 96450, Germany
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Demmin, 17109, Germany
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Dortmund, 44263, Germany
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München, 80331, Germany
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Baja, 6500, Hungary
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Budapest, 1071, Hungary
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Esztergom, 2500, Hungary
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Hódmezővásárhely, 6800, Hungary
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Kalocsa, 6300, Hungary
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Kecskemét, 6001, Hungary
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Szigetvár, 7390, Hungary
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Vác, 2600, Hungary
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Hadera, 38100, Israel
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Jerusalem, 91031, Israel
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Kfar Saba, 44281, Israel
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Nahariya, 22100, Israel
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Rehovot, 76100, Israel
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Brescia, 25123, Italy
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Chieti, 66013, Italy
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Ferrara, 44100, Italy
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Genova, 16132, Italy
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La Spezia, 19124, Italy
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Lecco, 23900, Italy
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Lodi, 26900, Italy
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Palermo, 90127, Italy
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Pavia, 27100, Italy
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Prato, 50047, Italy
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Roma, 00186, Italy
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S Fermo Della Battaglia, 22020, Italy
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Gdansk, 80-211, Poland
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Katowice, 40-027, Poland
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Lodz, 90-153, Poland
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Radom, 20-610, Poland
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Rzeszów, 35-055, Poland
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Sieradz, 98-200, Poland
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Szczecin, 70-111, Poland
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Warsaw, 02-006, Poland
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A Coruña, 15006, Spain
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Barcelona, 08025, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Ciudad Real, 13005, Spain
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L'Hospitalet de Llobregat, 08907, Spain
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Lleida, 25198, Spain
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Madrid, 28007, Spain
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Málaga, 29010, Spain
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Partida La Ceñuela. Torreviej, 03186, Spain
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Belfast, BT9 7LJ, United Kingdom
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Birmingham, B15 2TH, United Kingdom
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Bradford, BD5 0NA, United Kingdom
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Exeter, EX2 5DW, United Kingdom
Related Publications (1)
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.
PMID: 36791280DERIVED
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 1, 2007
First Posted
March 2, 2007
Study Start
September 1, 2007
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
December 19, 2011
Results First Posted
October 3, 2011
Record last verified: 2011-12