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

July 5, 2016 updated by: Hoffmann-La Roche

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Week 8
Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Hemoglobin >11 g/dL After 4-Week Extension Phase
Time Frame: Week 12
Week 12
Percentage of Participants With Hemoglobin >11 g/dL After 4-Week Continuation Phase
Time Frame: Week 12
Week 12
Quality of Life of Participants as Assessed From Short Form 36 (SF-36) Scores
Time Frame: Baseline, Week 8, 12
Baseline, Week 8, 12
Percentage of Participants With Positive Response to Questionnaire for Practicality and Safety of Self-administration of Study Drug
Time Frame: Week 8, 12
Week 8, 12
Number of Participants With Local Injection Site Reactions
Time Frame: Up to 12 weeks
Up to 12 weeks
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 12 weeks
Up to 12 weeks
Number of Participants With Chronic Kidney Disease
Time Frame: Baseline
Baseline
Response to Treatment at the end of the Correction Phase Among Participants With Different Time Since Diabetes Diagnosis
Time Frame: Week 8
Week 8
Response to Treatment at the end of the Correction Phase Among Participants With Different Hemoglobin Levels at Baseline
Time Frame: Week 8
Week 8
Response to Treatment at the end of the Correction Phase Among Participants With Different Hematocrit at Baseline
Time Frame: Week 8
Week 8
Number of Participants per Category of History of Medical Disorders and Surgical Procedures
Time Frame: Baseline
Baseline
Number of Participants per Type of Diabetes
Time Frame: Week 8, 12
Week 8, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • ML18730

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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