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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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