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

PHASE3CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

October 31, 2005

Primary Completion Date

January 31, 2008

Study Completion Date

January 31, 2008

Conditions
Anemia
Interventions
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.

Trial Locations (78)

4100

Blois

13090

Aix-en-Provence

13362

Marseille

13500

Martigues

17108

Saintes

19312

Brivé

21079

Dijon

22027

Saint-Brieuc

25030

Besançon

26953

Valence

27023

Évreux

28000

Chartres

29000

Quimper

30029

Valence

30932

Nîmes

31059

Toulouse

31603

Muret

33000

Bordeaux

33076

Bordeaux

33077

Bordeaux

34097

Montpellier

34500

Béziers

38317

Bourgoin

38700

La Tronche

40024

Mont-de-Marsan

45000

Orléans

49000

Angers

50009

Saint-Lô

51092

Reims

54511

Vandœuvre-lès-Nancy

57126

Thionville

58033

Nevers

59037

Lille

59300

Valenciennes

59604

Maubeuge

60000

Beauvais

60100

Creil

62022

Arras

62320

Bois-Bernard

62321

Boulogne

63058

Clermont-Ferrand

63400

Chamalières

66330

Cabestany

67504

Haguenau

68024

Colmar

69400

Greize

69495

Pierre-Bénite

72037

Le Mans

74500

Évian-les-Bains

75017

Paris

75651

Paris

75908

Paris

76083

Le Havre

76100

Rouen

76233

Bois-Guillaume

76700

Harfleur

77011

Melun

77220

Tournan-en-Brie

78190

Trappes

78303

Poissy

79021

Niort

80480

Salouël

83830

Figanières

85925

La Roche-sur-Yon

86021

Poitiers

87042

Limoges

89108

Sens

91014

Évry

93105

Montreuil

93300

Aubervilliers

94010

Créteil

94275

Le Kremlin-Bicêtre

94320

Thiais

94415

Saint-Maurice

07103

Annonay

01012

Bourg-en-Bresse

05000

Gap

06721

Saint-Laurent-du-Var

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02827266 - A Study of Epoetin Beta (NeoRecormon) in Anemic Participants With Diabetes and Chronic Renal Failure Who Are Not on Dialysis | Biotech Hunter | Biotech Hunter