370
Participants
Start Date
July 31, 2005
Primary Completion Date
March 31, 2007
Study Completion Date
March 31, 2010
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.
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."
Azathioprine
2 mg/kg/day orally, provided as 50 mg capsules to be taken after meals.
Placebo to Azathioprine
Placebo capsules matching Azathioprine taken orally once a day.
Placebo to Mycophenolate mofetil
Placebo tablets matching Mycophenolate mofetil taken orally twice daily.
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.
Brussels
Camperdown
Szeged
Leuven
Parkville
Melbourne
Liège
Debrecen
Woodville
Córdoba
Pécs
New York
New York
New York
Berlin
Lake Success
Brooklyn
Athens
Athens
Mexico City
Berlin
Pittsburgh
Philadelphia
Milan
Baltimore
Bad Bramstedt
Brescia
Durham
Madrid
Málaga
Charleston
Atlanta
Hanover
Toulouse
Udine
Miami
Padua
Huntsville
Santander
Düsseldorf
Seville
Columbus
Nantes
Cleveland
Münster
Aachen
Pisa
Lille
Chicago
Chicago
Columbia
Lyon
Heraklion
Oklahoma City
Dallas
Paris
Paris
San Luis Potosí City
München
München
Los Angeles
Torrance
Erlangen
La Jolla
San Francisco
San Leandro
Mérida
Beijing
Shanghai
Jiangsu
Guangdong
Guangzhou
Boston
Ann Arbor
Chapel Hill
Buenos Aires
Buenos Aires
San Isidro
San Miguel de Tucumán
Adelaide
Rio de Janeiro
São Paulo
Sorocaba
Vancouver
Victoria
Halifax
London
Toronto
Montreal
Brno
Prague
Dresden
Leipzig
Lisbon
Porto
Alicante
Barcelona
Barcelona
Birmingham
Cambridge
Leeds
London
London
London
Manchester
Newcastle upon Tyne
Sheffield
Southampton
Collaborators (1)
Aspreva Pharmaceuticals
INDUSTRY
Hoffmann-La Roche
INDUSTRY