A Study of Epoetin Beta (NeoRecormon) in Anemic Participants With Diabetes and Chronic Renal Failure Who Are Not on Dialysis

NCT02827266 | Completed Phase 3

• 1 other identifier: ML18730
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 78

Brief Summary

This study will evaluate the effect of epoetin beta (NeoRecormon) on correction of anemia and quality of life in participants with diabetes and chronic renal failure and who are not receiving dialysis.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Hemoglobin Greater Than (>) 11 Grams per Deciliter (g/dL) After 8-Week Correction Phase

  Week 8

Secondary Outcomes (12)

• Percentage of Participants With Hemoglobin >11 g/dL After 4-Week Extension Phase

  Week 12

• Percentage of Participants With Hemoglobin >11 g/dL After 4-Week Continuation Phase

  Week 12

• Quality of Life of Participants as Assessed From Short Form 36 (SF-36) Scores

  Baseline, Week 8, 12

• Percentage of Participants With Positive Response to Questionnaire for Practicality and Safety of Self-administration of Study Drug

  Week 8, 12

• Number of Participants With Local Injection Site Reactions

  Up to 12 weeks

Study Arms (1)

Epoetin beta

EXPERIMENTAL

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.

Drug: Epoetin beta

Interventions

Epoetin beta DRUG

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.

Also known as: NeoRecormon and RO 205-3859

Epoetin beta

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 or 2 diabetes
• 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)

You may not qualify if:

• Anemia due to a non-renal cause
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (78)

Unknown Facility

Aix-en-Provence, 13090, France

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Angers, 49000, France

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Annonay, 07103, France

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Arras, 62022, France

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Aubervilliers, 93300, France

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Beauvais, 60000, France

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Besançon, 25030, France

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Béziers, 34500, France

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Blois, 4100, France

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Bois-Bernard, 62320, France

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Bois-Guillaume, 76233, France

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Bordeaux, 33000, France

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Bordeaux, 33076, France

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Bordeaux, 33077, France

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Boulogne, 62321, France

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Bourg-en-Bresse, 01012, France

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Bourgoin, 38317, France

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Brivé, 19312, France

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Cabestany, 66330, France

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Chamalières, 63400, France

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Chartres, 28000, France

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Clermont-Ferrand, 63058, France

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Colmar, 68024, France

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Creil, 60100, France

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Créteil, 94010, France

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Dijon, 21079, France

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Évian-les-Bains, 74500, France

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Évreux, 27023, France

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Évry, 91014, France

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Figanières, 83830, France

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Gap, 05000, France

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Greize, 69400, France

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Haguenau, 67504, France

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Harfleur, 76700, France

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La Roche-sur-Yon, 85925, France

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La Tronche, 38700, France

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Le Havre, 76083, France

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Le Kremlin-Bicêtre, 94275, France

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Le Mans, 72037, France

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Lille, 59037, France

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Limoges, 87042, France

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Marseille, 13362, France

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Martigues, 13500, France

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Maubeuge, 59604, France

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Melun, 77011, France

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Mont-de-Marsan, 40024, France

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Montpellier, 34097, France

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Montreuil, 93105, France

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Muret, 31603, France

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Nevers, 58033, France

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Niort, 79021, France

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Nîmes, 30932, France

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Orléans, 45000, France

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Paris, 75017, France

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Paris, 75651, France

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Paris, 75908, France

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Pierre-Bénite, 69495, France

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Poissy, 78303, France

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Poitiers, 86021, France

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Quimper, 29000, France

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Reims, 51092, France

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Rouen, 76100, France

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Saint-Brieuc, 22027, France

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Saint-Laurent-du-Var, 06721, France

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Saint-Lô, 50009, France

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Saint-Maurice, 94415, France

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Saintes, 17108, France

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Salouël, 80480, France

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Sens, 89108, France

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Thiais, 94320, France

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Thionville, 57126, France

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Toulouse, 31059, France

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Tournan-en-Brie, 77220, France

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Trappes, 78190, France

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Valence, 26953, France

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Valence, 30029, France

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Valenciennes, 59300, France

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Vandœuvre-lès-Nancy, 54511, France

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MeSH Terms

Conditions

Anemia

Interventions

epoetin beta

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: July 11, 2016
• Study Start: October 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: July 11, 2016

Record last verified: 2016-07

Locations

FR (78)