18
Participants
Start Date
January 15, 2025
Primary Completion Date
January 20, 2026
Study Completion Date
January 15, 2027
Grafalon® administered during 5 consecutive days at 2 mg/kg/j
"This de-escalation study was planned to investigate 3 doses level of Grafalon® administered during 5 consecutive days, i.e.:~Group 3 : 2 mg/kg/j, Group 2 : 1 mg/kg/j, Group 1 : 0,5 mg/kg/j.~Group 3 receives treatment in accordance with health recommendations as part of prophylactic treatment for acute rejection after allogeneic solid organ transplantation, at the minimum dose, i.e., 2 to 5 mg/kg/day for 5 to 21 days."
Grafalon® administered during 5 consecutive days at 1 mg/kg/j
"This de-escalation study was planned to investigate 3 doses level of Grafalon® administered during 5 consecutive days, i.e.:~Group 3 : 2 mg/kg/j, Group 2 : 1 mg/kg/j, Group 1 : 0,5 mg/kg/j.~Group 2 receive treatment at lower doses than the recommended dose for the same duration (5 days). Treatment begins on the day of transplantation immediately before the procedure at induction of sedation."
Grafalon® administered during 5 consecutive days at 0,5 mg/kg/j
"This de-escalation study was planned to investigate 3 doses level of Grafalon® administered during 5 consecutive days, i.e.:~Group 3 : 2 mg/kg/j, Group 2 : 1 mg/kg/j, Group 1 : 0,5 mg/kg/j.~Group 1 receive treatment at lower doses than the recommended dose for the same duration (5 days). Treatment begins on the day of transplantation immediately before the procedure at induction of sedation"
Centre Hospitalier Universitaire de Besancon
OTHER