Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids

PHASE3TerminatedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

January 31, 2011

Study Completion Date

January 31, 2011

Conditions
Renal Transplant Rejection
Interventions
DRUG

ATG-Fresenius S

"Dosage: Single high-dose of 9 mg/kg pre-operatively, followed by 3 mg/kg/d at day +2 and +4. ATG-Fresenius treatment at Days 0, +2, and +4 is mandatory.~(In case of persisting DGF, the treatment is left to the discretion of the investigator. Treatment options include the continuation of ATG-Fresenius treatment with 3 mg/kg/d at Day +6 and if deemed necessary also at Day +8 - but without corticosteroids)."

Trial Locations (10)

15006

Hospital Universitario Juan Canalejo, A Coruña

28007

Hosptial Gregorio Maranon, Madrid

28040

Fundación Jiménez Díaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

2799-523

Centro Hospitalar de Lisboa Ocidental, Carnaxide

3000-075

Hospitais da Universidade de Coimbra, Coimbra

1069-166

Hospital de Curry Cabral, Lisbon

4090-001

Hospital Geral de Santo António, SA, Porto

08036

Hospital Universitari Clinic i Provincial, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Eurotrials Brasil Consultores Cientificos Ltda

INDUSTRY

collaborator

Recerca Clínica S.L.

INDUSTRY

collaborator

PsyConsult

UNKNOWN

lead

Neovii Biotech

INDUSTRY

NCT01324934 - Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids | Biotech Hunter | Biotech Hunter