The study is undertaken to explore the safety of using Simulect at monthly dose intervals to reduce the need of high dose/level CNI's such as Prograf.
The use of CNI's after kidney transplantation is associated with typical adverse effects such as potential contribution to progressive impairment of renal function, hypertension, and metabolic abnormalities. The study consists of a run-in phase (1 month),and treatment phase (11 months) and safety assessment phase (1 month).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Simulect 20 mg intravenously day of transplant and day 4
Simulect (basiliximab) 20mg intravenously day of transplant and day 4 post operatively. Then Monthly administration of Simulect (basiliximab) 40 mg intravenously for one year duration.
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
To evaluate the risk of sensitization against the chimeric antibody, Simulect.
Time frame: one year
To describe the pharmacokinetics of Simulect over the study course.
Time frame: one year
To determine the absolute and relative number of CD25 receptors on T cells at the end of each dosing interval.
Time frame: one year
To assess the difference in calculated and measured GFR.
Time frame: one year
To assess the difference in biopsy proven acute rejection rates and the acute and chronic parameters (chronic allograft injury) on surveillance biopsies.
Time frame: one year
To assess the difference in vital signs and lab abnormalities
Time frame: one year
To determine the difference in incidence and severity of albuminuria/proteinuria
Time frame: one year
To collect safety data on infections and malignancies
Time frame: one year
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