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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00235300 |
A multicenter clinical study comparing event-free survival at 6 months after transplant between Thymoglobulin-treated and Simulect-treated adult kidney transplant patients. Patients received Thymoglobulin or Simulect from Day 0 through Day 4. Day 0 was considered the day of the transplant procedure.
Subjects meeting all inclusion and exclusion criteria were eligible to participate in this study. The treatment assignment was random and not chosen by the subject or their physician.
Subjects were monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurred up to 12 months after transplant.
278 study subjects were enrolled at 28 transplant centers in the United States and Europe.
Condition | Intervention | Phase |
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Cadaveric Donor Renal Transplantation Acute Renal Allograft Rejection Induction Therapy |
Biological: Thymoglobulin [Anti-thymocyte Globulin (rabbit)] Drug: Simulect (basliximab) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Prospective, Randomized, Multicenter Phase II Comparative Trial of Thymoglobulin® Versus Simulect® for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients |
Enrollment: | 240 |
Study Start Date: | May 2000 |
Study Completion Date: | June 2005 |
Primary Completion Date: | April 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 Control: Active Comparator
Simulect (basiliximab)
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Drug: Simulect (basliximab)
20 mg per day on 2 days
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2: Experimental
Thymoglobulin (anti-thymocyte globulin (rabbit))
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Biological: Thymoglobulin [Anti-thymocyte Globulin (rabbit)]
1.5 mg/kg per day, for a maximum of 5 doses
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Per Lindner, M.D., Ph.D. | Genzyme |
Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
Study ID Numbers: | SMC-101-1010 |
Study First Received: | October 6, 2005 |
Last Updated: | April 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00235300 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-T cells antibodies Cadaveric Donor Renal Transplantation Acute Renal Allograft Rejection Induction Therapy |
Antilymphocyte Serum Basiliximab Antibodies Immunologic Factors |
Delayed Graft Function Immunosuppressive Agents Immunoglobulins |
Antilymphocyte Serum Basiliximab Pathologic Processes Immunologic Factors |
Physiological Effects of Drugs Delayed Graft Function Immunosuppressive Agents Pharmacologic Actions |