80
Participants
Start Date
October 31, 2005
Primary Completion Date
May 31, 2008
Study Completion Date
June 30, 2008
Reparixin continuous infusion
The Investigational Product was administered as an intravenous infusion into a (high flow) central vein or through an arterio-venous fistula, by an infusion pump adequate to provide reliable infusion rates, as per treatment schedule. Total infusion volume did not exceed 500 mL/24 hours. A dose of 2.772 mg/kg body weight/hour was to be administered for 12 hours. Placebo was volume/schedule matched saline.
reparixin intermittent infusion
A dose of 2.244 mg/kg body weight was to be administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were to be administered over a total period of 22.5 hours. Placebo was volume/schedule matched saline.
placebo infusion
placebo was volume/schedule matched saline
Division of Transplantation, Drexel University College of Medicine, Philadelphia
Divisione di Nefrologia e Dialisi, Ospedali Riuniti di Bergamo, Bergamo
Divisione di Nefrologia e Dialisi, Azienda Ospedaliera Spedali Civili di Brescia, Brescia
Università degli Studi di Padova, Clinica Chirurgica III, Padua
Transplant Center, University of Minnesota Medical School, Minneapolis
Service de Nephrologie et Transplantation, Hopital Lapeyronie, Centre Hospitalier Universitaire Montpellier, Montpellier
Service de Transplantation et Soins Intensifs Nephrologiques, Hopital Necker, Paris
Renal Transplant Unit, Hopital Clinic i Provincial de Barcelona, Barcelona
Division of Nephrology, Institut Catala de la Salut, Ciutat Sanitaria i Universitaria de Bellvitge, Barcelona
Dompé Farmaceutici S.p.A
INDUSTRY