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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
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The purpose of this study is to evaluate the safety and efficacy of induction therapy with Thymoglobulin in comparison with IL2 receptor antagonists (daclizumab or basiliximab).
A 12 month, prospective, randomized, single center, open-label study to evaluate the safety and efficacy of Rabbit anti-thymocyte globulin versus IL2 receptor antagonists in combination with tacrolimus, corticosteroids and mycophenolate mofetil in a predominantly high risk kidney transplant population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thymoglobulin | Active Comparator | Subjects receiving Thymoglobulin as induction agent in renal transplantation |
|
| Zenapax | Active Comparator | subject who will receive daclizumab or basiliximab as induction agent in renal transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rabbit Antithymocyte globulin | Drug | 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Efficacy Will be Defined as the Number of Patients With Biopsy Proven Acute Rejection at One Year Post-transplant. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth D Chavin, MD,PhD | Medical University of South Carolina | Study Chair |
| Nicole Pilch, PharmD | Medical University of South Carolina | Study Chair |
| David Taber, PharmD | Medical University of South Carolina | Study Chair |
| Prabhakar Baliga, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25557762 | Derived | Palanisamy AP, Al Manasra AR, Pilch NA, Dowden JE, Nadig SN, McGillicuddy JW, Baliga PK, Chavin KD, Taber DJ. Induction therapy: clinical and quality of life outcomes in aged renal transplant recipients. Clin Transplant. 2015 Mar;29(3):222-6. doi: 10.1111/ctr.12507. Epub 2015 Jan 27. | |
| 24513787 | Derived | Pilch NA, Taber DJ, Moussa O, Thomas B, Denmark S, Meadows HB, McGillicuddy JW, Srinivas TR, Baliga PK, Chavin KD. Prospective randomized controlled trial of rabbit antithymocyte globulin compared with IL-2 receptor antagonist induction therapy in kidney transplantation. Ann Surg. 2014 May;259(5):888-93. doi: 10.1097/SLA.0000000000000496. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Thymoglobulin | Subjects receiving Thymoglobulin as induction agent in renal transplantation Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4 |
| FG001 | Zenapax | subject who will receive daclizumab or basiliximab as induction agent in renal transplantation Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Thymoglobulin | Subjects receiving Thymoglobulin as induction agent in renal transplantation Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4 |
| BG001 | Zenapax |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Efficacy Will be Defined as the Number of Patients With Biopsy Proven Acute Rejection at One Year Post-transplant. | Posted | Number | participants | One year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Thymoglobulin | Subjects receiving Thymoglobulin as induction agent in renal transplantation Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BK Viremia | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Chavin, MD, PhD | Medical University of South Carolina | 843-792-3368 | chavinkd@musc.edu |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C512542 | thymoglobulin |
| D000077561 | Daclizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Daclizumab | Drug | 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7 |
|
|
| 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 |
subject who will receive daclizumab or basiliximab as induction agent in renal transplantation
Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Number of Patients Requiring Antilymphocyte Therapy for Acute Rejection. | Posted | Number | Patients | One year |
|
|
|
| Secondary | Graft Survival at One Year Post-transplant | Posted | Number | participants | One year |
|
|
|
| Secondary | 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 | Posted | Number | participants | one year |
|
|
|
| Secondary | Incidence of Post-transplant Malignancies, Including Post-transplant Lymphoproliferative Disease (PTLD) and Skin Cancers. | Posted | Number | participants | One year |
|
|
|
| Secondary | Incidence of Leukopenia, Defined as a Total White Blood Cell Count of Less Than 2,000 Cells/mm3 | Posted | Number | participants | One year |
|
|
|
| Secondary | Incidence of Thrombocytopenia, Defined as a Platelet Count of Less Than 100,000 Cells/mm3 | Posted | Number | participants | One year |
|
|
|
| 0 |
| 102 |
| 37 |
| 102 |
| EG001 | Zenapax | subject who will receive daclizumab or basiliximab as induction agent in renal transplantation Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7 | 0 | 98 | 44 | 98 |
| CMV | Immune system disorders |
|
| Bacterial Infection | Infections and infestations |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |