Optimal Dose of Anti-lymphocyte Globulin in Kidney Transplant Recipients With Low Immunological Risk

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

January 15, 2025

Primary Completion Date

January 20, 2026

Study Completion Date

January 15, 2027

Conditions
Renal Transplantation
Interventions
DRUG

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."

DRUG

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."

DRUG

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"

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Besancon

OTHER