901
Participants
Start Date
May 31, 2003
Primary Completion Date
March 31, 2005
Study Completion Date
April 30, 2006
Mycophenolate Mofetil
"1 g for adult patients and 300 mg/m2 for paediatric patients. Fixed dose arm: 1 g twice a day (bid) for adults and 600mg/m2 bid for paediatric patients.~Concentration controlled arm: initial dose will be 1 g bid for adults and 600mg/m2 bid for paediatric patients. Abbreviated AUCs (taken at timepoints: 0, 30min and 120min in fasted patients) on Days 3 and 10, Week 4, Months 3, 6 and 12 will be performed to determine mycophenolic acid levels in plasma."
Vilnius University Hospital, Vilnius
John Hunter Hospital, New Lambton
Leids Universitair Medisch Centrum, Leiden
University Hospitals Leuven, Leuven
Erasmus Medical Center Rotterdam, Rotterdam
Royal Melbourne Hospital, Parkville
St Vincent's Hospital, Melbourne
Monash Medical Centre, Clayton
Princess Alexandra Hospital, Brisbane
Odense University Hospital, Odense
Sir Charles Gairdner Hospital, Nedlands
Royal Perth Hospital, Perth
Med. Univ. Klinik, Graz
Hospital Sant Joan de Deu, Barcelona
Universitatsklinikum Charite, Berlin
Hospital Reina Sofia, Córdoba
Complejo Hospitalario Univeritario de Santiago, Santiago de Compostela
Hospital de las Nieves, Granada
Hospital du Bocage, Dijon
Hospital Ramon Y Cajal, Madrid
Fundacion Jimenez Diaz, Madrid
Hospital Clinico San Carlos, Madrid
La Paz, Madrid
CHU Purpan, Toulouse
CHU Rangueil, Toulouse
Hopital Pellegrin, C.H.R.de Bordeaux, Bordeaux
CHU de Grenoble, Grenoble
Hospital Virgen del Rocio, Seville
CHU Hotel Dieu, Nantes
Stadt Kliniken Koln, Cologne
Surgical Clinic Of Tartu University Clinics, Tartu
CHU de Nancy-Brabois, Vandœuvre-lès-Nancy
Hopital Calmette, Lille
Hopital Jeanne de Flandres, Lille
Universitatsklinikum Heidelberg, Heidelberg
University of Heidelberg, Heidelberg
Centre Hospitalier Lyon Sud, Pierre-Bénite
Hopital Necker, Paris
Hopital Tenon, Paris
Chirurgische Universitätsklinik, Freiburg im Breisgau
Centre Hospitalier Regional Universitaire, Limoges
Hopital Foch, Suresnes
CHU Kremlin Bicêtre, Le Kremlin-Bicêtre
University Hospital Wurzburg, Würzburg
Ruijin Hospital, Shanghai
AKH Wien, Vienna
Hospital do Rim e Hipertensao, São Paulo
Vancouver General Hospital, Vancouver
West China Hospital of Sichuan University, Chengdu
Hospital Son Dureta, Palma de Mallorca
Hospital Dr. Peset, Valencia
National Taiwan University Hospital, Taipei
"Hospital Miguel Perez Carreno", Caracas
Hospital Universitario de Caracas, Caracas
Hospital Universitario de Maracaibo, Maracaibo
Rikshopitalet, Oslo
Institute of Transplantology, Medical University of Warsaw, Warsaw
Children's Memorial Health Institute, Warsaw
Hospital Infanta Christa, Badajoz
Hospital Del Mar, Barcelona
Valle de Hebron, Barcelona
University Hospital, Malmo, Malmo
Karolinska University Hospital, Huddinge, Stockholm
University Hospital A, Uppsala
Royal Free Hospital, London
Guys and St Thomas's Hospital, London
St George's Hospital, London
Lead Sponsor
Hoffmann-La Roche
INDUSTRY
Erasmus Medical Center
OTHER