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Sponsored by: |
University of Miami |
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Information provided by: | University of Miami |
ClinicalTrials.gov Identifier: | NCT00685061 |
To compare in a randomized prospective study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy vs. our conventional therapy in recipients of first cadaver (CAD) kidneys.
Condition | Intervention | Phase |
---|---|---|
Renal Transplantation |
Drug: Thymoglobulin Drug: Campath-1H Drug: Daclizumab |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Head-to-Head Comparison of Thymoglobulin vs. Campath-1H vs. Our Standard Center Treatment Protocol in Cadaver Donor Renal Transplantation: A Study to Evaluate the Avoidance of Long-Term Nephrotoxic Calcineurin Inhibitor Therapy |
Enrollment: | 90 |
Study Start Date: | November 2002 |
Study Completion Date: | September 2005 |
Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Thymoglobulin Induction
|
Drug: Thymoglobulin
Induction
|
B: Experimental
Campath-1H Induction
|
Drug: Campath-1H
Induction
|
C: Experimental
Daclizumab Induction
|
Drug: Daclizumab
Induction
|
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | University of Miami Division of Transplantation ( George W. Burke ) |
Study ID Numbers: | IRB#20020213 |
Study First Received: | May 23, 2008 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00685061 |
Health Authority: | United States: Institutional Review Board |
Adult, primary deceased donor kidney transplant recipients |
Death Daclizumab Alemtuzumab |
Immunologic Factors Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |