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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Fingolimod Hydrochloride

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