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AnemiaPhase 3NCT02827266

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

A Phase 3 study testing Epoetin beta in people with Anemia, run by Hoffmann-La Roche at 78 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia
What is being tested?
Epoetin beta
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
78 sitesFrance
Study dates
Oct 2005to Jan 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

78 sites in 1 country.

78 sites in 1 country

France78 sites

  • Study site

    Aix-en-Provence, 13090

  • Study site

    Angers, 49000

  • Study site

    Annonay, 07103

  • Study site

    Arras, 62022

  • Study site

    Aubervilliers, 93300

  • Study site

    Beauvais, 60000

  • Study site

    Besançon, 25030

  • Study site

    Béziers, 34500

  • Study site

    Blois, 4100

  • Study site

    Bois-Bernard, 62320

  • Study site

    Bois-Guillaume, 76233

  • Study site

    Bordeaux, 33000

  • Study site

    Bordeaux, 33076

  • Study site

    Bordeaux, 33077

  • Study site

    Boulogne, 62321

  • Study site

    Bourg-en-Bresse, 01012

  • Study site

    Bourgoin, 38317

  • Study site

    Brivé, 19312

  • Study site

    Cabestany, 66330

  • Study site

    Chamalières, 63400

  • Study site

    Chartres, 28000

  • Study site

    Clermont-Ferrand, 63058

  • Study site

    Colmar, 68024

  • Study site

    Creil, 60100

  • Study site

    Créteil, 94010

  • Study site

    Dijon, 21079

  • Study site

    Évian-les-Bains, 74500

  • Study site

    Évreux, 27023

  • Study site

    Évry, 91014

  • Study site

    Figanières, 83830

  • Study site

    Gap, 05000

  • Study site

    Greize, 69400

  • Study site

    Haguenau, 67504

  • Study site

    Harfleur, 76700

  • Study site

    La Roche-sur-Yon, 85925

  • Study site

    La Tronche, 38700

  • Study site

    Le Havre, 76083

  • Study site

    Le Kremlin-Bicêtre, 94275

  • Study site

    Le Mans, 72037

  • Study site

    Lille, 59037

  • Study site

    Limoges, 87042

  • Study site

    Marseille, 13362

  • Study site

    Martigues, 13500

  • Study site

    Maubeuge, 59604

  • Study site

    Melun, 77011

  • Study site

    Mont-de-Marsan, 40024

  • Study site

    Montpellier, 34097

  • Study site

    Montreuil, 93105

  • Study site

    Muret, 31603

  • Study site

    Nevers, 58033

  • Study site

    Nîmes, 30932

  • Study site

    Niort, 79021

  • Study site

    Orléans, 45000

  • Study site

    Paris, 75017

  • Study site

    Paris, 75651

  • Study site

    Paris, 75908

  • Study site

    Pierre-Bénite, 69495

  • Study site

    Poissy, 78303

  • Study site

    Poitiers, 86021

  • Study site

    Quimper, 29000

  • Study site

    Reims, 51092

  • Study site

    Rouen, 76100

  • Study site

    Saint-Brieuc, 22027

  • Study site

    Saint-Laurent-du-Var, 06721

  • Study site

    Saint-Lô, 50009

  • Study site

    Saint-Maurice, 94415

  • Study site

    Saintes, 17108

  • Study site

    Salouël, 80480

  • Study site

    Sens, 89108

  • Study site

    Thiais, 94320

  • Study site

    Thionville, 57126

  • Study site

    Toulouse, 31059

  • Study site

    Tournan-en-Brie, 77220

  • Study site

    Trappes, 78190

  • Study site

    Valence, 26953

  • Study site

    Valence, 30029

  • Study site

    Valenciennes, 59300

  • Study site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: 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.

Conditions
Anemia
Being tested
Epoetin beta
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epoetin betaDrug

    Also called NeoRecormon and RO 205-3859

    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.

Study groups in NCT02827266
Study groupRoleWhat they receive
Epoetin betaExperimentalParticipants 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.
Receives: Drug: Epoetin beta

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Week 8

Secondary outcomes (12)

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

    Measured: Week 12

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

    Measured: Week 12

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

    Measured: Baseline, Week 8, 12

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

    Measured: Week 8, 12

  5. Number of Participants With Local Injection Site Reactions

    Measured: Up to 12 weeks

  6. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Up to 12 weeks

  7. Number of Participants With Chronic Kidney Disease

    Measured: Baseline

  8. Response to Treatment at the end of the Correction Phase Among Participants With Different Time Since Diabetes Diagnosis

    Measured: Week 8

  9. Response to Treatment at the end of the Correction Phase Among Participants With Different Hemoglobin Levels at Baseline

    Measured: Week 8

  10. Response to Treatment at the end of the Correction Phase Among Participants With Different Hematocrit at Baseline

    Measured: Week 8

  11. Number of Participants per Category of History of Medical Disorders and Surgical Procedures

    Measured: Baseline

  12. Number of Participants per Type of Diabetes

    Measured: Week 8, 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2016 (estimated)
  2. Study startOct 2005
  3. Primary completionJan 2008
  4. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02827266
Sponsor's protocol ID
ML18730
Status last verified
Jul 2016
First submitted
5 Apr 2016
Last updated
11 Jul 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epoetin beta in people with Anemia, run by Hoffmann-La Roche at 78 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Hemoglobin Greater Than (>) 11 Grams per Deciliter (g/dL) After 8-Week Correction Phase (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02827266.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.

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