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 efficacy of replacing the calcineurin inhibitors by using basiliximab at monthly doses.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
7
40 mg once every 28 days intravenously for 24 weeks
1g MMF or 720mg EC-MPS p.o twice daily
Oral corticosteroids, equivalent to prednisone p.o, ≥ 5mg daily or ≥ 10mg on alternate days
Novartis
Basel, Switzerland
to describe the pharmacokinetics of basiliximab over the 6-month study course and to determine whether serum concentrations remain above CD25 receptor saturation levels
Time frame: 6 months
to evaluate the risk of sensitization against the chimeric antibody over 6 months
Time frame: 6 months
to assess the changes in renal parameters after CNI discontinuation
Time frame: Month 1-6 post trasnplant
to assess the quantifiable changes in vital signs and lab abnormalities possibly related to CNIs
Time frame: 6 months
to assess semi-quantitatively changes of clinical symptoms possibly related to CNIs
Time frame: 6 month
to determine the percentage of CD25 positive T cells (CD3) during therapy with Simulect
Time frame: 24 weeks
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