(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Early Diabetic Nephropathy
NCT ID: NCT00354341
Last Updated: 2016-03-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
170 participants
INTERVENTIONAL
2002-09-30
2005-07-31
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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Group 1 (Early Epoetin Beta)
Along with their standard treatment participants will receive epoetin beta at a starting dose of 2000 International Units (IU) subcutaneously (SC) once weekly to reach and maintain target hemoglobin (Hb) between 13 and 15 grams per deciliter (g/dL), for 15 months. Epoetin beta doses will be adjusted according to individual participant's Hb level. Standard treatment will be as per investigator discretion.
Epoetin beta
Group 2 (No/Late Epoetin Beta)
Participants will receive their standard treatment for 15 months but no treatment for anemia correction unless Hb level will be less than (\<) 10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level will be \<10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment will be as per investigator discretion.
Epoetin beta
Interventions
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Epoetin beta
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* type 1 or type 2 diabetes;
* stable glycemic control for \>=3 months;
* diabetic nephropathy.
Exclusion Criteria
* previous treatment with erythropoietin or other erythropoietic substance;
* nondiabetic renal disease, nephrotic syndrome;
* blood transfusion within the 3 months prior to enrollment;
* administration of any investigational drug within 30 days preceding the study start, and during the study.
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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Ebenhard Ritz, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
unaffliated
Locations
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Linz, , Austria
São Paulo, , Brazil
Jihlava, , Czechia
Liberec, , Czechia
Copenhagen, , Denmark
Roskilde, , Denmark
Jyväskylä, , Finland
Heidelberg, , Germany
München, , Germany
Alexandroupoli, , Greece
Athens, , Greece
Ioannina, , Greece
Nikaia, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Véria, , Greece
Budapest, , Hungary
Budapest, , Hungary
Miskolc, , Hungary
Pécs, , Hungary
Szombathely, , Hungary
Ancona, , Italy
Cagliari, , Italy
Caserta, , Italy
Cinisello Balsamo, , Italy
Desio, , Italy
Lecco, , Italy
Messina, , Italy
Milan, , Italy
Milan, , Italy
Chihuahua City, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Bialystok, , Poland
Katowice, , Poland
Radom, , Poland
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Singapore, , Singapore
A Coruña, , Spain
Barakaldo, , Spain
Barcelona, , Spain
Galdakao, , Spain
Madrid, , Spain
Madrid, , Spain
Valencia, , Spain
Stockholm, , Sweden
Bangkok, , Thailand
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Chon Buri, , Thailand
Belfast, , United Kingdom
Cambridge, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Middlesbrough, , United Kingdom
Salford, , United Kingdom
Sheffield, , United Kingdom
Wrexham, , 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.
Ritz E, Laville M, Bilous RW, O'Donoghue D, Scherhag A, Burger U, de Alvaro F; Anemia Correction in Diabetes Study Investigators. Target level for hemoglobin correction in patients with diabetes and CKD: primary results of the Anemia Correction in Diabetes (ACORD) Study. Am J Kidney Dis. 2007 Feb;49(2):194-207. doi: 10.1053/j.ajkd.2006.11.032.
Other Identifiers
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MA16620
Identifier Type: -
Identifier Source: org_study_id
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