Status:
COMPLETED
Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney organ transplant
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
684 Patients enrolled
Trial Details
Trial ID
NCT00239785
Start Date
April 1 2003
Last Update
August 22 2017
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