A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.

PHASE3CompletedINTERVENTIONAL
Enrollment

370

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

March 31, 2007

Study Completion Date

March 31, 2010

Conditions
Lupus Nephritis
Interventions
DRUG

Mycophenolate mofetil (MMF)

Supplied as 500 mg tablets taken orally twice a day (BID). Dose specific for each arm. Dosing started at 500 mg BID for the first week, increasing by 500 mg in subsequent weeks until the final target dose was reached.

DRUG

Cyclophosphamide

"Intravenous cyclophosphamide (IVC) was administered every four weeks (monthly) to a total of six infusions.~Dosing was started at 0.75 g/m\^2 of body surface area for the first month, with subsequent doses at 0.5-1.0 g/m\^2. The target dose was 1.0 g/m\^2, but doses were titrated by 0.25 g/m\^2 increments to maintain nadir leukocyte count between 2500-4000/mm\^3."

DRUG

Azathioprine

2 mg/kg/day orally, provided as 50 mg capsules to be taken after meals.

DRUG

Placebo to Azathioprine

Placebo capsules matching Azathioprine taken orally once a day.

DRUG

Placebo to Mycophenolate mofetil

Placebo tablets matching Mycophenolate mofetil taken orally twice daily.

DRUG

Corticosteroid

Oral prednisolone (or equivalent) starting at a dose of 0.75-1.0 mg/kg/day (maximum 60 mg/day) tapered to 10 mg/day.

Trial Locations (108)

1200

Brussels

2050

Camperdown

2724

Szeged

3000

Leuven

3052

Parkville

3168

Melbourne

4000

Liège

4032

Debrecen

5011

Woodville

5016

Córdoba

7632

Pécs

10003

New York

10021

New York

10032

New York

10117

Berlin

11042

Lake Success

11203

Brooklyn

11521

Athens

11527

Athens

14000

Mexico City

14059

Berlin

15213

Pittsburgh

19104

Philadelphia

20149

Milan

21205

Baltimore

24576

Bad Bramstedt

25125

Brescia

27710

Durham

28041

Madrid

29010

Málaga

29425

Charleston

30303

Atlanta

30625

Hanover

31059

Toulouse

33100

Udine

33136

Miami

35128

Padua

35801

Huntsville

39008

Santander

40225

Düsseldorf

41013

Seville

43210

Columbus

44035

Nantes

44136

Cleveland

48149

Münster

52074

Aachen

56100

Pisa

59037

Lille

60611

Chicago

60637

Chicago

65212

Columbia

69437

Lyon

71500

Heraklion

73104

Oklahoma City

75390

Dallas

75679

Paris

75877

Paris

78240

San Luis Potosí City

80336

München

81675

München

90095

Los Angeles

90502

Torrance

91054

Erlangen

92037

La Jolla

94143

San Francisco

94578

San Leandro

97000

Mérida

100034

Beijing

200001

Shanghai

210002

Jiangsu

510008

Guangdong

510630

Guangzhou

02115

Boston

48109-0358

Ann Arbor

27599-7280

Chapel Hill

C1015ABO

Buenos Aires

C1425DQK

Buenos Aires

B1602BPPD

San Isidro

T4000AXL

San Miguel de Tucumán

SA 5000

Adelaide

20551-030

Rio de Janeiro

04039-020

São Paulo

18030-210

Sorocaba

V5Z 1L7

Vancouver

V8Z 7X8

Victoria

B3H 2Y9

Halifax

N6A 4V2

London

M5T 2S8

Toronto

H1T 2M4

Montreal

656 91

Brno

128 08

Prague

01307

Dresden

04103

Leipzig

Unknown

Lisbon

4200-319

Porto

03010

Alicante

08035

Barcelona

08036

Barcelona

B15 2TT

Birmingham

CB2 2QQ

Cambridge

LS1 3EX

Leeds

SE1 7EH

London

W12 OHS

London

WIT 4NJ

London

M13 9WL

Manchester

NE7 7DN

Newcastle upon Tyne

S10 2JF

Sheffield

SO16 6YD

Southampton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Aspreva Pharmaceuticals

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY

NCT00377637 - A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis. | Biotech Hunter | Biotech Hunter