A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
An Open-label, Randomized, Multicenter, Parallel-group Study to Demonstrate Correction of Anemia Using Once Every 4 Weeks Subcutaneous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are Not on Dialysis
1 other identifier
interventional
307
16 countries
76
Brief Summary
This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kilogram (mcg/kg), or darbepoetin alfa once weekly, at a starting dose of 0.45 mcg/kg (or once every two weeks, 0.75 mcg/kg). The anticipated time on study treatment is 3-12 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2007
76 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
November 15, 2007
CompletedFirst Posted
Study publicly available on registry
November 16, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
November 1, 2016
CompletedNovember 1, 2016
September 1, 2016
1.8 years
November 15, 2007
September 13, 2016
September 13, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Hemoglobin (Hb) Response
Hb response was an observed increase in Hb greater than or equal to (\>=) 1.0 gram per deciliter (g/dL) from baseline and an Hb concentration \>= 10.0 g/dL before the end of the study without red blood cells (RBC) transfusion before response.
Baseline up to Week 28
Change in Hemoglobin (Hb) Concentration Between Baseline and Evaluation Period
A time adjusted average baseline 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 2 month evaluation period (Week 21 to 28). The change in Hb concentration between the baseline and evaluation period 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 -2, Week -1 and Day 1) and Evaluation Period (Week 22, Week 24, Week 26, Week 28)
Secondary Outcomes (6)
Hemoglobin (Hb) Concentration Over the Time
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and final visit (Week 29)
Time to Hemoglobin Response
Baseline up to Week 28
Percentage of Participants With Red Blood Cell (RBC) Transfusions
Baseline up to Week 28
Percentage of Participants Who Had at Least 1 Hemoglobin Value Exceeding 12.0 g/dL
Baseline to Week 8
Percentage of Participants With Stable Hemoglobin Response
Baseline to Week 28
- +1 more secondary outcomes
Study Arms (2)
Mircera
EXPERIMENTALParticipants will receive Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
Darbepoetin Alfa
ACTIVE COMPARATORParticipants will receive darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
Interventions
1.2 mcg/kg SC monthly, starting dose
0.45 mcg/kg SC weekly or 0.75 mcg/kg every 2 weeks, starting dose
Eligibility Criteria
You may qualify if:
- Participants with chronic kidney disease (CKD) stage 3 (creatinine clearance \[CrCl\]/ glomerular filtration rate \[GFR\] 30 to 59 milliliter per minutes per 1.73 meter square \[mL/min/1.73m\^2\]) or Stage 4 (CrCl/GFR 15-29 mL/min/1.73m\^2) who did not require dialysis. CrCl/GFR was estimated with the Cockcroft-Gault equation or the abbreviated Modification of Diet in Renal Disease (MDRD) equation
- Anemia defined as baseline Hb concentration less than (\<) 10.5 gram per deciliter (g/dL)
You may not qualify if:
- Previous therapy with any ESA within 12 weeks prior to screening
- Renal allograft in place
- Immunosuppressive therapy in the 12 weeks prior to screening
- Overt gastrointestinal bleeding and red blood cells (RBC) transfusions within 8 weeks before screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (76)
Unknown Facility
Adelaide, 5011, Australia
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Clayton, 3186, Australia
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Gosford, 2250, Australia
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Parkville, 3052, Australia
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Reservoir, 3073, Australia
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Aalst, 9300, Belgium
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Roeselare, 8800, Belgium
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Edmonton, Alberta, T6G 2B7, Canada
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London, Ontario, N6A 5A5, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Cahors, 46005, France
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Clermont-Ferrand, 63000, France
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Limoges, 87042, France
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Lyon, 69437, France
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Nice, 06002, France
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Paris, 75651, France
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Berlin, 13353, Germany
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Bonn, 53127, Germany
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Heilbronn, 74076, Germany
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Homburg/saar, 66424, Germany
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Alexandroupoli, 68100, Greece
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Larissa, 41 110, Greece
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Thessaloniki, 54636, Greece
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Volos, 38222, Greece
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Hong Kong, Hong Kong
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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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Hatvan, 3000, Hungary
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Szigetvár, 7390, Hungary
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Haifa, 34362, Israel
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Kfar Saba, 44281, Israel
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Petah Tikva, 49100, Israel
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Como, 22100, Italy
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Lecco, 23900, Italy
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Lodi, 26900, Italy
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Mestre, 30174, Italy
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Modena, 41100, Italy
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Pavia, 27100, Italy
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Gdansk, 80-211, Poland
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Katowice, 40-027, Poland
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Krakow, 31-501, Poland
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Lodz, 90-153, Poland
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Radom, 26-610, 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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Wroclaw, 50-417, Poland
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Moscow, 117036, Russia
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Moscow, 125101, Russia
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Moscow, 129110, Russia
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Saint Petersburg, 191015, Russia
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Saint Petersburg, 195067, Russia
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Saint Petersburg, 197089, Russia
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Saint Petersburg, 197110, Russia
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Saratov, 410053, Russia
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Seoul, 120-752, South Korea
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Seoul, 133-792, South Korea
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Seoul, South Korea
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Barcelona, 08025, Spain
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Barcelona, 08907, Spain
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Madrid, 28046, Spain
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Madrid, 28922, Spain
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Palma de Mallorca, 07014, Spain
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Seville, 41009, Spain
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Seville, 41013, Spain
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Valencia, 46017, Spain
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Taichung, 407, Taiwan
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Taipei, 100, Taiwan
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Bangkok, Thailand
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Nakhon Ratchasima, 30000, Thailand
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Pathum Thani, 12120, Thailand
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
- Hoffmann-La Roche
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
November 15, 2007
First Posted
November 16, 2007
Study Start
December 1, 2007
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
November 1, 2016
Results First Posted
November 1, 2016
Record last verified: 2016-09