Clinical Trial Details
| Trial ID: | L0936 |
| Source ID: | NCT00859131 |
| Associated Drug: | Rabbit Antithymocyte Globulin |
| Title: | Safety and Efficacy Study of Thymoglobulin Versus IL2 Receptor Antagonists |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00859131/results |
| Conditions: | End Stage Renal Disease |
| Interventions: | DRUG: Rabbit Antithymocyte globulin|DRUG: Daclizumab |
| Outcome Measures: | Primary: Treatment Efficacy Will be Defined as the Number of Patients With Biopsy Proven Acute Rejection at One Year Post-transplant., One year | Secondary: Number of Patients Requiring Antilymphocyte Therapy for Acute Rejection., One year|Graft Survival at One Year Post-transplant, One year|Incidence of Post-transplant Infections, Including, But Not Limited to, CMV Infection and Disease, BK Infection and Nephropathy, Other Opportunistic Infections, Urinary Tract Infections, Pneumonia, and Sepsis, one year|Incidence of Post-transplant Malignancies, Including Post-transplant Lymphoproliferative Disease (PTLD) and Skin Cancers., One year|Incidence of Leukopenia, Defined as a Total White Blood Cell Count of Less Than 2,000 Cells/mm3, One year|Incidence of Thrombocytopenia, Defined as a Platelet Count of Less Than 100,000 Cells/mm3, One year |
| Sponsor/Collaborators: | Sponsor: Medical University of South Carolina | Collaborators: Genzyme, a Sanofi Company |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | |
| Enrollment: | 200 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: |
| Start Date: | 2009-03 |
| Completion Date: | 2014-07 |
| Results First Posted: | 2016-04-26 |
| Last Update Posted: | 2016-04-26 |
| Locations: | Medical University of South Carolina, Charleston, South Carolina, 29425, United States |
| URL: | https://clinicaltrials.gov/show/NCT00859131 |
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