Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant (Simulect)
|ClinicalTrials.gov Identifier: NCT00928811|
Recruitment Status : Terminated (Investigator left University 04/2010)
First Posted : June 26, 2009
Last Update Posted : February 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease||Drug: basiliximab||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||One-year Exploratory Study to Evaluate the Safety of Partial Replacement of CNI With Chronic Administration of Simulect in de Novo Normal-risk Kidney Transplant Recipients Treated With MPA|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Standard of care administration with Simulect (basiliximab)being administered as per induction therapy on day of transplant and day 4.
Simulect 20 mg intravenously day of transplant and day 4
Other Name: Simulect
Simulect (basiliximab) intravenously day of transplant and day 4.
Chronic Simulect (basiliximab) administration monthly for one year duration.
Concomitant decrease in Prograf administration.
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.
Other Name: 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928811
|United States, Pennsylvania|
|Drexel University College of Medicine|
|Philadelphia, Pennsylvania, United States, 19102|
|Principal Investigator:||Mysore Anil S. Kumar, MD||Drexel University College of Medicine|