A Phase 2/3 interventional study of basiliximab and basiliximab in End Stage Renal Disease, sponsored by Drexel University College of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-02-10.
Sponsored by Drexel University College of Medicine · Phase 2/3, Interventional, and Treatment
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).
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 261 are open to participants now.
This study's enrollment of 5 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Drexel University College of Medicine is the lead sponsor of 26 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard of care administration with Simulect (basiliximab)being administered as per induction therapy on day of transplant and day 4.
Drug: basiliximab
Simulect (basiliximab) intravenously day of transplant and day 4. Chronic Simulect (basiliximab) administration monthly for one year duration. Concomitant decrease in Prograf administration.
Drug: basiliximab
Simulect 20 mg intravenously day of transplant and day 4
Also known as: Simulect
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.
Also known as: Simulect (basiliximab)
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
This study is terminated, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Drexel University College of Medicine