A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia

PHASE3CompletedINTERVENTIONAL
Enrollment

1,228

Participants

Timeline

Start Date

October 31, 2004

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
Anemia
Interventions
DRUG

Methoxy Polyethylene Glycol-Epoetin Beta

Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in 2-mL glass vials containing 1 mL solution or in single-use sterile pre-filled syringes (PFSs) containing 0.3 mL or 0.6 mL injectable solution. The injectable solution was available in vials with the following strengths: 50, 100, 200, 400, and 1000 μg/mL. The injectable solution was available in PFSs with the following strengths: 30, 40, 50, 60, 75, 100, 120, 150, 200, and 250 μg/0.3 mL; and 360 and 400 μg/0.6 mL.

DRUG

Epoetin alfa

Epoetin alfa was provided with commercial packaging in English with country-specific labels (10,000 IU, 20,000 IU).

DRUG

Epoetin beta

Epoetin beta was provided with commercial packaging in English with country-specific labels (50,000 IU, 100,000 IU).

DRUG

Darbepoetin alfa

Darbepoetin alfa was provided with commercial packaging in English with country-specific labels (vials and PFSs in various strengths).

Trial Locations (249)

100

Taipei

407

Taichung

1003

Lausanne

1011

Lausanne

1076

Budapest

1134

Budapest

1200

Brussels

1871

Liverpool

2250

Gosford

2650

Edegem

3000

Leuven

3050

Parkville

3186

Clayton

3500

Hasselt

3526

Miskolc

4000

Liège

Roskilde

4032

Debrecen

4102

Woolloongabba

5000

Odense

5001

Aarau

6847

Perth

7006

Trondheim

7624

Pécs

7925

Cape Town

8036

Graz

9000

Ghent

9100

Aalborg

9300

Aalst

10021

New York

10128

New York

10330

Bangkok

10400

Bangkok

10467

The Bronx

10700

Bangkok

11021

Great Neck

11203

Brooklyn

11355

Flushing

11501

Mineola

12045

Berlin

12100

Cuneo

14000

Mexico City

14004

Córdoba

14033

Caen

14127

Orchard Park

14186

Huddinge

15006

A Coruña

15224

Pittsburgh

15706

Santiago de Compostela

16132

Genova

16502

Erie

17044

Lewistown

18103

Allentown

18288

Stockholm

18536

Piraeus

19106

Philadelphia

19140

Philadelphia

19141

Philadelphia

22020

S Fermo Della Battaglia

22031

Fairfax

23900

Lecco

24128

Bergamo

24153

Salem

25198

Lleida

26100

Cremona

26506

Morgantown

26900

Lodi

27030

Mount Airy

27100

Pavia

27609

Raleigh

28006

Madrid

28007

Madrid

28041

Madrid

28046

Madrid

28222

Madrid

28805

Madrid

28922

Alcorcón

29010

Málaga

29118

Orangeburg

29209

Columbia

30029

Nîmes

30122

Venezia

30174

Mestre

30309

Augusta

30342

Atlanta

31059

Toulouse

33006

Oviedo

33028

Pembroke Pines

33076

Bordeaux

33521

Tampere

34295

Montpellier

34471

Ocala

35211

Birmingham

36106

Montgomery

36251

Bad Hersfeld

36608

Mobile

37008

Salamanca

37044

Tours

37205

Nashville

37232

Nashville

37404

Chattanooga

38700

La Tronche

38801

Tupelo

39008

Santander

39705

Columbus

41013

Seville

41100

Modena

41110

Larissa

42103

Wuppertal

43606

Toledo

44093

Nantes

44109

Cleveland

44263

Dortmund

45500

Ioannina

48013

Bilbao

48236

Detroit

49007

Kalamazoo

50047

Prato

50200

Chiang Mai

54629

Thessaloniki

55430

Brooklyn Center

57100

Livorno

57126

Thionville

60153

Maywood

60473

South Holland

62321

Boulogne

62448

Cuernavaca

63110

St Louis

64115

Bayonne

65000

Phitsanulok

65013

Tarbes

65185

Karlstad

65191

Wiesbaden

66046

Perpignan

66330

Cabestany

68024

Colmar

68100

Alexandroupoli

69168

Wiesloch

69437

Lyon

70191

Stuttgart

70884

Baton Rouge

71101

Shreveport

71901

Hot Springs

73001

Chambéry

75216

Dallas

75908

Paris

76233

Bois-Guillaume

77030

Houston

77054

Houston

77099

Houston

78054

Villingen-Schwenningen

78100

Saint-Germain-en-Laye

78758

Austin

80260

Lakewood

80262

Denver

80480

Salouël

80804

München

80909

Colorado Springs

83400

Hyères

86021

Poitiers

87042

Limoges

87131

Albuquerque

89100

Reggio Calabria

90073

Los Angeles

90095

Los Angeles

90185

Umeå

90431

Nuremberg

90720

Los Alamitos

91034

Cagliari

91054

Erlangen

91356

Encino

91723

Covina

91754

Monterey Park

92120

San Diego

92123

San Diego

92868

Irvine

93400

Saint-Ouen

94040

Mountain View

94117

San Francisco

94305

Stanford

96813

Honolulu

97045

Oregon City

97210

Portland

98158

Messina

123182

Moscow

125101

Moscow

129110

Moscow

195067

Saint Petersburg

197089

Saint Petersburg

95816-5119

Sacramento

06902

Stamford

40202-1718

Louisville

02115

Boston

02135

Boston

01107

Springfield

48202-2689

Detroit

07601

Hackensack

07503

Paterson

27599-7155

Chapel Hill

45267-0585

Cincinnati

97201-2940

Portland

05401

Burlington

23507-1901

Norfolk

NSW 2148

Sydney

460 63

Liberec

708 52

Ostrava

304 60

Pilsen

00029

HUS

6419 PC

Heerlen

Unknown

Panama City

Durban

Soweto

Bangkok

Chon Buri

80-211

Gdansk

81-519

Gdynia

25-736

Kielce

31-501

Krakow

90-153

Lodz

60-355

Poznan

35-055

Rzeszów

70-111

Szczecin

02-006

Warsaw

05-200

Wołomin

50-417

Wroclaw

2910-446

Setúbal

00732

Ponce

03010

Alicante

04009

Almería

08915

Badalona

08003

Barcelona

08035

Barcelona

08036

Barcelona

08907

L'Hospitalet de Llobregat

07014

Palma de Mallorca

07198

Palma de Mallorca

BT9 7LJ

Belfast

CB2 2QQ

Cambridge

SM5 1AA

Carshalton

DD1 9SY

Dundee

EX2 5DW

Exeter

G4 OSF

Glasgow

LE5 4PW

Leicester

E1 1BB

London

SE1 9RT

London

SE22 8PT

London

SW17 0RE

London

M6 8HD

Salford

SA6 6NL

Swansea

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT00090753 - A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia | Biotech Hunter | Biotech Hunter