Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant
Phase 2
Completed
- Conditions
- Kidney Transplantation
- Registration Number
- NCT00099749
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 255
Inclusion Criteria
- Male and Female
- Between 18 to 65 years old
Exclusion Criteria
- Patients in need of multiple organ transplants
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation, within 6 months post transplantation.
- Secondary Outcome Measures
Name Time Method Efficacy parameters between the 3 treatment groups within 6 and 12 months post-transplantation. Safety/tolerability based on adverse event reporting. BPAR, graft loss, death and study discontinuation, within 6 and 12 months post transplantation.
Trial Locations
- Locations (5)
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
SIU School of Medicine
🇺🇸Springfield, Illinois, United States
St. Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Loyola University Medical Center🇺🇸Maywood, Illinois, United States