Status:
COMPLETED
Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids
Lead Sponsor:
Novartis
Conditions:
Kidney Transplantation
Adverse Effects
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The long-term use of calcineurin inhibitors (CNI) in patients who have received a kidney transplantation is associated with renal dysfunction and hypertension. The study will evaluate the safety and e...
Eligibility Criteria
Inclusion
- Patients with a first kidney transplant from a living or deceased donor at least 12 months after transplantation.
- Patients receiving CNI, mycophenolic acid (MPA) and oral corticosteroids.
- Patients who are able to tolerate full dose MPA.
- Patients with glomerular filtration rate (GFR) \> 30 mL/min.
- Patients without an acute rejection episode during the preceding 6 months.
- Patients with signs or symptoms of CNI intolerance (renal dysfunction, poor blood pressure control, diabetes, poor lipid control, hyperuricemia and gout, significant hypophosphatemia or hypomagnesemia, gingival hyperplasia, hypertrichosis, etc.) in whom CNI interruption is justified.
Exclusion
- Patients with preformed positive skin test against basiliximab
- Patients with preformed panel reactive antibody (PRA) \> 10%.
- Signs of active immune process on graft biopsy.
- Patients with multi-organ or second kidney transplant
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00284947
Start Date
January 1 2006
End Date
December 1 2008
Last Update
March 29 2017
Active Locations (1)
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1
Novartis
Basel, Switzerland