| Trial ID: | L0813 |
| Source ID: | NCT00928811
|
| Associated Drug: |
Basiliximab
|
| Title: |
Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant
|
| Acronym: |
Simulect
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease
|
| Interventions: |
DRUG: basiliximab|DRUG: basiliximab
|
| Outcome Measures: |
Primary: To evaluate the risk of sensitization against the chimeric antibody, Simulect., one year | Secondary: To describe the pharmacokinetics of Simulect over the study course., one year|To determine the absolute and relative number of CD25 receptors on T cells at the end of each dosing interval., one year|To assess the difference in calculated and measured GFR., one year|To assess the difference in biopsy proven acute rejection rates and the acute and chronic parameters (chronic allograft injury) on surveillance biopsies., one year|To assess the difference in vital signs and lab abnormalities, one year|To determine the difference in incidence and severity of albuminuria/proteinuria, one year|To collect safety data on infections and malignancies, one year
|
| Sponsor/Collaborators: |
Sponsor: Drexel University College of Medicine | Collaborators: Novartis
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
5
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-05
|
| Completion Date: |
2010-04
|
| Results First Posted: |
|
| Last Update Posted: |
2015-02-10
|
| Locations: |
Drexel University College of Medicine, Philadelphia, Pennsylvania, 19102, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00928811
|
