A Study of Epoetin Beta (NeoRecormon) in Anemic Participants With Diabetes and Chronic Renal Failure Who Are Not on Dialysis
NCT ID: NCT02827266
Last Updated: 2016-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
122 participants
INTERVENTIONAL
2005-10-31
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Epoetin beta
Participants will receive epoetin beta over an 8-week correction phase and a 4-week extension or continuation phase, for a total exposure of up to 12 weeks.
Epoetin beta
Participants will receive epoetin beta as a weekly subcutaneous (SC) injection over an 8-week correction phase with 60 international units per kilograms (IU/kg) as starting dose. Baseline weight will be used to determine the dose and adjustments in the dose will be implemented based on the participant's blood hemoglobin levels. Participants with a response to correction treatment will then enter a 4-week extension phase to receive the SC injection every 2 weeks, and those without response will continue at the same weekly dose for a 4-week continuation phase.
Interventions
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Epoetin beta
Participants will receive epoetin beta as a weekly subcutaneous (SC) injection over an 8-week correction phase with 60 international units per kilograms (IU/kg) as starting dose. Baseline weight will be used to determine the dose and adjustments in the dose will be implemented based on the participant's blood hemoglobin levels. Participants with a response to correction treatment will then enter a 4-week extension phase to receive the SC injection every 2 weeks, and those without response will continue at the same weekly dose for a 4-week continuation phase.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic renal failure (stage 2 to stage 5) defined by Glomerular Filtration Rate (GFR) less than (\<) 90 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2)
* Anemia related to chronic kidney disease and requiring treatment with erythropoiesis-stimulating agent (ESA) (2 values of hemoglobin less than or equal to 11 gram per deciliter \[g/dL\] during the 3 months prior to inclusion), and hemoglobin greater than 8 g/dL
Exclusion Criteria
* Poorly controlled hypertension
* Treatment with an erythropoiesis stimulating agent (ESA) within 3 months prior to the study
* Planned dialysis in next 3 months or organ transplant
* History of cancer except for basal cell cancer and cervical cancer in situ
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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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Aix-en-Provence, , France
Angers, , France
Annonay, , France
Arras, , France
Aubervilliers, , France
Beauvais, , France
Besançon, , France
Béziers, , France
Blois, , France
Bois-Bernard, , France
Bois-Guillaume, , France
Bordeaux, , France
Bordeaux, , France
Bordeaux, , France
Boulogne, , France
Bourg-en-Bresse, , France
Bourgoin, , France
Brivé, , France
Cabestany, , France
Chamalières, , France
Chartres, , France
Clermont-Ferrand, , France
Colmar, , France
Creil, , France
Créteil, , France
Dijon, , France
Évian-les-Bains, , France
Évreux, , France
Évry, , France
Figanières, , France
Gap, , France
Greize, , France
Haguenau, , France
Harfleur, , France
La Roche-sur-Yon, , France
La Tronche, , France
Le Havre, , France
Le Kremlin-Bicêtre, , France
Le Mans, , France
Lille, , France
Limoges, , France
Marseille, , France
Martigues, , France
Maubeuge, , France
Melun, , France
Mont-de-Marsan, , France
Montpellier, , France
Montreuil, , France
Muret, , France
Nevers, , France
Niort, , France
Nîmes, , France
Orléans, , France
Paris, , France
Paris, , France
Paris, , France
Pierre-Bénite, , France
Poissy, , France
Poitiers, , France
Quimper, , France
Reims, , France
Rouen, , France
Saint-Brieuc, , France
Saint-Laurent-du-Var, , France
Saint-Lô, , France
Saint-Maurice, , France
Saintes, , France
Salouël, , France
Sens, , France
Thiais, , France
Thionville, , France
Toulouse, , France
Tournan-en-Brie, , France
Trappes, , France
Valence, , France
Valence, , France
Valenciennes, , France
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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ML18730
Identifier Type: -
Identifier Source: org_study_id
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