Clinical trial NCT02827266: A Study of Epoetin Beta (NeoRecormon) in Anemic Participants With Diabetes and Chronic Renal Failure Who Are Not on Dialysis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-07-11
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Hemoglobin Greater Than (>) 11 Grams per Deciliter (g/dL) After 8-Week Correction Phase
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of Participants With Hemoglobin >11 g/dL After 4-Week Extension Phase
timeFrame: Week 12
measure: Percentage of Participants With Hemoglobin >11 g/dL After 4-Week Continuation Phase
timeFrame: Week 12
measure: Quality of Life of Participants as Assessed From Short Form 36 (SF-36) Scores
timeFrame: Baseline, Week 8, 12
measure: Percentage of Participants With Positive Response to Questionnaire for Practicality and Safety of Self-administration of Study Drug
timeFrame: Week 8, 12
measure: Number of Participants With Local Injection Site Reactions
timeFrame: Up to 12 weeks
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 12 weeks
measure: Number of Participants With Chronic Kidney Disease
timeFrame: Baseline
measure: Response to Treatment at the end of the Correction Phase Among Participants With Different Time Since Diabetes Diagnosis
timeFrame: Week 8
measure: Response to Treatment at the end of the Correction Phase Among Participants With Different Hemoglobin Levels at Baseline
timeFrame: Week 8
measure: Response to Treatment at the end of the Correction Phase Among Participants With Different Hematocrit at Baseline
timeFrame: Week 8
measure: Number of Participants per Category of History of Medical Disorders and Surgical Procedures
timeFrame: Baseline
measure: Number of Participants per Type of Diabetes
timeFrame: Week 8, 12
Other outcomes:
Locations:
city: Aix En Provence
country: France
city: Angers
country: France
city: Annonay
country: France
city: Arras
country: France
city: Aubervilliers
country: France
city: Beauvais
country: France
city: Besancon
country: France
city: Beziers
country: France
city: Blois
country: France
city: Bois Bernard
country: France
city: Bois-guillaume
country: France
city: Bordeaux
country: France
city: Bordeaux
country: France
city: Bordeaux
country: France
city: Boulogne
country: France
city: Bourg En Bresse
country: France
city: Bourgoin Jallieu
country: France
city: Brive
country: France
city: Cabestany
country: France
city: Chamalieres
country: France
city: Chartres
country: France
city: Clermont-ferrand
country: France
city: Colmar
country: France
city: Creil
country: France
city: Creteil
country: France
city: Dijon
country: France
city: Evian Les Bains
country: France
city: Evreux
country: France
city: Evry
country: France
city: Figanieres
country: France
city: GAP
country: France
city: Greize
country: France
city: Haguenau
country: France
city: Harfleur
country: France
city: La Roche Sur Yon
country: France
city: La Tronche
country: France
city: Le Havre
country: France
city: Le Kremlin-bicetre
country: France
city: Le Mans
country: France
city: Lille
country: France
city: Limoges
country: France
city: Marseille
country: France
city: Martigues
country: France
city: Maubeuge
country: France
city: Melun
country: France
city: Mont-de-marsan
country: France
city: Montpellier
country: France
city: Montreuil
country: France
city: Muret
country: France
city: Nevers
country: France
city: Nimes
country: France
city: Niort
country: France
city: Orleans
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Pierre Benite
country: France
city: Poissy
country: France
city: Poitiers
country: France
city: Quimper
country: France
city: Reims
country: France
city: Rouen
country: France
city: Saint Laurent Du Var
country: France
city: Saint Lo
country: France
city: Saintes
country: France
city: Salouel
country: France
city: Sens
country: France
city: St Brieuc
country: France
city: St Maurice
country: France
city: Thiais
country: France
city: Thionville
country: France
city: Toulouse
country: France
city: Tournan-en-brie
country: France
city: Trappes
country: France
city: Valence
country: France
city: Valence
country: France
city: Valenciennes
country: France
city: Vandoeuvre-les-nancy
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: