Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

Novartis

Status and phase

Completed

Phase 3

Conditions

Renal Transplantation

Treatments

Drug: FTY720

Study type

Interventional

Funder types

Industry

Identifiers

NCT00239785

CFTY720A0124

Details and patient eligibility

About

This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney organ transplant

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Male and female patients of any race between 18 to 65 years old (inclusive)
Patients scheduled to undergo a primary cadaveric or primary non-HLA identical living donor kidney transplantation
Patients who gave written informed consent to participate in the study Exclusion Criteria
Recipients of multi-organ transplantation or foreseen to receive a non-renal allograft during the study period
Graft cold ischemia time greater than 40 hours.
Patients with pulse rate < 50 beats per minute (bpm) at screening Other protocol-defined exclusion criteria may apply