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

NADIR: Multicentre, Open-Label Trial Evaluating a Simple NeoRecormon Regimen in Anemic Patients With Diabetes and Chronic Kidney Disease (Stage 2 to 5) Who Are Not on Dialysis

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: Epoetin beta

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Aix En Provence, France, 13090
  • Angers, France, 49000
  • Annonay, France, 07103
  • Arras, France, 62022
  • Aubervilliers, France, 93300
  • Beauvais, France, 60000
  • Besancon, France, 25030
  • Beziers, France, 34500
  • Blois, France, 4100
  • Bois Bernard, France, 62320
  • Bois-guillaume, France, 76233
  • Bordeaux, France, 33076
  • Bordeaux, France, 33000
  • Bordeaux, France, 33077
  • Boulogne, France, 62321
  • Bourg En Bresse, France, 01012
  • Bourgoin Jallieu, France, 38317
  • Brive, France, 19312
  • Cabestany, France, 66330
  • Chamalieres, France, 63400
  • Chartres, France, 28000
  • Clermont-ferrand, France, 63058
  • Colmar, France, 68024
  • Creil, France, 60100
  • Creteil, France, 94010
  • Dijon, France, 21079
  • Evian Les Bains, France, 74500
  • Evreux, France, 27023
  • Evry, France, 91014
  • Figanieres, France, 83830
  • GAP, France, 05000
  • Greize, France, 69400
  • Haguenau, France, 67504
  • Harfleur, France, 76700
  • La Roche Sur Yon, France, 85925
  • La Tronche, France, 38700
  • Le Havre, France, 76083
  • Le Kremlin-bicetre, France, 94275
  • Le Mans, France, 72037
  • Lille, France, 59037
  • Limoges, France, 87042
  • Marseille, France, 13362
  • Martigues, France, 13500
  • Maubeuge, France, 59604
  • Melun, France, 77011
  • Mont-de-marsan, France, 40024
  • Montpellier, France, 34097
  • Montreuil, France, 93105
  • Muret, France, 31603
  • Nevers, France, 58033
  • Nimes, France, 30932
  • Niort, France, 79021
  • Orleans, France, 45000
  • Paris, France, 75908
  • Paris, France, 75651
  • Paris, France, 75017
  • Pierre Benite, France, 69495
  • Poissy, France, 78303
  • Poitiers, France, 86021
  • Quimper, France, 29000
  • Reims, France, 51092
  • Rouen, France, 76100
  • Saint Laurent Du Var, France, 06721
  • Saint Lo, France, 50009
  • Saintes, France, 17108
  • Salouel, France, 80480
  • Sens, France, 89108
  • St Brieuc, France, 22027
  • St Maurice, France, 94415
  • Thiais, France, 94320
  • Thionville, France, 57126
  • Toulouse, France, 31059
  • Tournan-en-brie, France, 77220
  • Trappes, France, 78190
  • Valence, France, 26953
  • Valence, France, 30029
  • Valenciennes, France, 59300
  • Vandoeuvre-les-nancy, France, 54511

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)
• 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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: 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 Names: NeoRecormon and RO 205-3859

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to 12 weeks
Number of Participants With Chronic Kidney Disease	Baseline
Response to Treatment at the end of the Correction Phase Among Participants With Different Time Since Diabetes Diagnosis	Week 8
Response to Treatment at the end of the Correction Phase Among Participants With Different Hemoglobin Levels at Baseline	Week 8
Response to Treatment at the end of the Correction Phase Among Participants With Different Hematocrit at Baseline	Week 8
Number of Participants per Category of History of Medical Disorders and Surgical Procedures	Baseline
Number of Participants per Type of Diabetes	Week 8, 12

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: April 5, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Estimate): July 11, 2016
• Last Update Submitted That Met QC Criteria: July 5, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML18730