A Study of Treatment With NeoRecormon (Epoetin Beta) in Patients With Chronic Renal Anemia
A Randomized, Open-label Study of the Effect of NeoRecormon on Reduction of Cardiovascular Risk in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy.
1 other identifier
interventional
605
22 countries
93
Brief Summary
This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 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 P75+ for phase_3
Started Jul 2000
Typical duration for phase_3
93 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
Study Start
First participant enrolled
July 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 3, 2006
CompletedFirst Posted
Study publicly available on registry
May 4, 2006
CompletedResults Posted
Study results publicly available
May 25, 2016
CompletedJune 29, 2016
May 1, 2016
4.3 years
May 3, 2006
February 24, 2016
May 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Median Time to First Cardiovascular Event
The cardiovascular event was defined as any of the following: angina pectoris leading to hospitalization for at least 24 hours or prolongation of hospitalization, acute heart failure, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, sudden death, transient cerebral ischemic attack (TIA), peripheral vascular disease (amputation, necrosis), cardiac arrhythmias leading to hospitalization for at least 24 hours or prolongation of hospitalization. The time to occurrence of a cardiovascular event was determined as the time from randomization until any of the above listed events whichever occurred first. The first event per participant was used for the analysis. Only events confirmed by the Endpoint Committee were considered for analysis.
Up to 4 years
Secondary Outcomes (17)
Median Time to Death Due to Cardiovascular Events
Up to 4 years
Number of Participants Who Died Due to Cardiovascular Events
Up to 4 years
Median Time to Death Due to All Causes
Up to 4 years
Number of Participants Who Died Due to All Causes
Up to 4 years
Number of Participants Experiencing Worsening of New York Heart Association (NYHA) Class (CL) of Chronic Heart Failure From Baseline (BL)
Up to 4 years
- +12 more secondary outcomes
Study Arms (2)
Early Epoetin Beta Therapy
EXPERIMENTALParticipants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
Late Epoetin Beta Therapy
ACTIVE COMPARATORParticipants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to \<10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Interventions
Participants in the early treatment group immediately started epoetin beta treatment to reach a target Hb level of 13-15 g/dL at the end of the correction phase.
Eligibility Criteria
You may qualify if:
- adult patients \>=18 years of age;
- chronic renal anemia;
- not receiving renal replacement therapy.
You may not qualify if:
- women who are pregnant or lactating;
- previous treatment with erythropoietin or other erythropoietic substance;
- blood transfusion within the last 3 months;
- need for dialysis expected in the next 6 months;
- administration of another investigational drug within 30 days preceding study start, or during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (93)
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Linz, 4020, Austria
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Sankt Pölten, 3100, Austria
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Brussels, 1070, Belgium
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Brussels, 1090, Belgium
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Edegem, 2650, Belgium
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Brno, 625 00, Czechia
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Havířov, 736 01, Czechia
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Olomouc, 775 20, Czechia
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Ostrava, 708 52, Czechia
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Fredericia, 7000, Denmark
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Herlev, 2730, Denmark
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Holbæk, 4300, Denmark
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Roskilde, 4000, Denmark
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Jyväskylä, 40620, Finland
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Tampere, 33521, Finland
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Amiens, 80054, France
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Angoulême, 16470, France
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Bordeaux, 33000, France
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Boulogne, 62321, France
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Colmar, 68024, France
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Lyon, 69437, France
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Montpellier, 34295, France
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Paris, 75743, France
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Saint-Brieuc, 22023, France
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Troyes, 10003, France
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Vandœuvre-lès-Nancy, 54511, France
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Berlin, 13353, Germany
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Villingen-Schwenningen, 78054, Germany
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Würzburg, 97072, Germany
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Athens, 115 27, Greece
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Thessaloniki, 546 42, Greece
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Véria, 59100, Greece
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Hong Kong, Hong Kong
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Dublin, 9, Ireland
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Bologna, 40138, Italy
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Busto Arsizio, 21052, Italy
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Cagliari, 09134, Italy
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Cinisello Balsamo, 20092, Italy
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Lecco, 23900, Italy
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Napoli, 80131, Italy
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Padua, 35128, Italy
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Parma, 43100, Italy
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Pavia, 27100, Italy
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Roma, 00144, Italy
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Roma, 00146, Italy
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Roma, 00152, Italy
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San Giovanni Rotondo, 71013, Italy
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Trieste, 34125, Italy
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Vimercate, 20059, Italy
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Cuernavaca, 62448, Mexico
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Tijuana, 44650, Mexico
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Oslo, 0407, Norway
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Gdansk, 80-211, Poland
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Kielce, 25-736, Poland
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Krakow, 31-501, Poland
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Wroclaw, 50-417, Poland
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Almada, 2800, Portugal
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Carnaxide, 2799-523, Portugal
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Lisbon, 1800-083, Portugal
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Porto, 4200-319, Portugal
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Moscow, 123182, Russia
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Moscow, 125101, Russia
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Moscow, Russia
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Saint Petersburg, 195067, Russia
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Saint Petersburg, 197110, Russia
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Barcelona, 08035, Spain
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Las Palmas de Gran Canaria, 35020, Spain
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Madrid, 28007, Spain
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Madrid, 28046, Spain
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Valencia, 46009, Spain
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Borås, 50182, Sweden
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Helsingborg, 25187, Sweden
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Jönköping, 55185, Sweden
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Karlstad, 65185, Sweden
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Norrköping, 60182, Sweden
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Örebro, 70185, Sweden
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Stockholm, 17176, Sweden
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Sundsvall, 85186, Sweden
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Taichung, 407, Taiwan
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Tainan, 701, Taiwan
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Taipei, 100, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Ankara, 06100, Turkey (Türkiye)
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Istanbul, 34390, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Belfast, BT9 7AB, United Kingdom
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London, SE22 8PT, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Salford, M6 8HD, United Kingdom
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Southampton, SO16 6YD, United Kingdom
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Surrey, SM5 1AA, United Kingdom
Related Publications (3)
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: 36791280DERIVEDLocatelli F, Eckardt KU, Macdougall IC, Tsakiris D, Clyne N, Burger HU, Scherhag A, Drueke TB; Cardiovascular Risk Reduction in Early Anaemia Trial with Epoetin Beta investigators and coordinators. Value of N-terminal brain natriuretic peptide as a prognostic marker in patients with CKD: results from the CREATE study. Curr Med Res Opin. 2010 Nov;26(11):2543-52. doi: 10.1185/03007995.2010.516237. Epub 2010 Sep 17.
PMID: 20849244DERIVEDDrueke TB, Locatelli F, Clyne N, Eckardt KU, Macdougall IC, Tsakiris D, Burger HU, Scherhag A; CREATE Investigators. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med. 2006 Nov 16;355(20):2071-84. doi: 10.1056/NEJMoa062276.
PMID: 17108342DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY CHAIR
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
May 3, 2006
First Posted
May 4, 2006
Study Start
July 1, 2000
Primary Completion
October 1, 2004
Study Completion
December 1, 2004
Last Updated
June 29, 2016
Results First Posted
May 25, 2016
Record last verified: 2016-05