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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
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This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed start of the anti-rejection drugs (10 days after liver transplant), compared to the current approach of starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2 days after the liver transplant.
Strong anti-rejection drugs like tacrolimus or cyclosporine, are given to patients who have received transplants, to ensure that the patient's body does not reject the new organ. In some cases, while anti-rejection medications protect a newly transplanted liver, they can injure the patient's kidneys and cause them not to work as well as they should. The purpose of this pilot study is to determine the best way to protect kidney function and to ensure that the newly transplanted liver is not rejected. This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed start of the anti-rejection drugs (10 days after liver transplant), compared to the current approach of starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2 days after the liver transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed CNI Group 1 | Experimental | Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration) |
|
| Delayed CNI Group 2 | Experimental | Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration) |
|
| Early CNI / Control Arm | Active Comparator | Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymoglobulin 3mg total | Biological | 1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Glomerular Filtration Rate (eGFR) at 12 Months Post-surgery | Postoperative acute kidney injury is measured as reduced (eGFR) within 12 months post-surgery. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Survival | 12 months post-transplant | |
| Graft Survival | 90% graft survival, related to the deaths of 3 patients during the study period. | 12 months post transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bijan Eghtesad, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic (Main Campus) | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Delayed CNI Group 1 | Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration) Thymoglobulin 3mg total: 1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg) Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180 |
| FG001 | Delayed CNI Group 2 | Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration) Thymoglobulin 4.5mg total: 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg) Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180 |
| FG002 | Early CNI / Control Arm | Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0). Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months tacrolimus 8-12: Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Delayed CNI Group 1 | Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration) Thymoglobulin 3mg total: 1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg) Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Estimated Glomerular Filtration Rate (eGFR) at 12 Months Post-surgery | Postoperative acute kidney injury is measured as reduced (eGFR) within 12 months post-surgery. | Posted | Median | 90% Confidence Interval | mL/min | 12 Months |
|
1 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 | Delayed CNI Group 1 | Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration) Thymoglobulin 3mg total: 1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg) Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Metastatic Lung Cancer | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HCV recurrence | Infections and infestations | Non-systematic Assessment | HCV recurrence in HCV positive recipients. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bijan Eghtesad | Cleveland Clinic | 2164029954 | eghtesb@ccf.org |
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| ID | Term |
|---|---|
| C512542 | thymoglobulin |
| D009173 | Mycophenolic Acid |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Thymoglobulin 4.5mg total | Biological | 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg) |
|
| Mycophenolate mofetil | Drug | 1000 mg PO/IV BID for up to 6 months |
|
|
| tacrolimus 3-8 | Drug | Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180 |
|
|
| tacrolimus 8-12 | Drug | Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180. |
|
|
| Allograft Rejection Rates at 30 Days | Acute Allograft Rejection | 30 days |
| BG001 | Delayed CNI Group 2 | Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration) Thymoglobulin 4.5mg total: 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg) Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180 |
| BG002 | Early CNI / Control Arm | Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0). Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months tacrolimus 8-12: Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration) Thymoglobulin 4.5mg total: 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg) Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180 |
| OG002 | Early CNI / Control Arm | Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0). Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months tacrolimus 8-12: Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180. |
|
|
| Secondary | Patient Survival | Kaplan- Meier | Posted | Count of Participants | Participants | No | 12 months post-transplant |
|
|
|
| Secondary | Graft Survival | 90% graft survival, related to the deaths of 3 patients during the study period. | Kaplan Meier for patient survival | Posted | Count of Participants | Participants | No | 12 months post transplant |
|
|
|
| Secondary | Allograft Rejection Rates at 30 Days | Acute Allograft Rejection | Posted | Count of Participants | Participants | No | 30 days |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 2 |
| 10 |
| EG001 | Delayed CNI Group 2 | Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration) Thymoglobulin 4.5mg total: 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg) Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months tacrolimus 3-8: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180 | 1 | 10 | 1 | 10 | 5 | 10 |
| EG002 | Early CNI / Control Arm | Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0). Mycophenolate mofetil: 1000 mg PO/IV BID for up to 6 months tacrolimus 8-12: Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180. | 2 | 10 | 1 | 10 | 4 | 10 |
| Graft vs Host Disease | Immune system disorders | Non-systematic Assessment |
|
| Heart Failure | Cardiac disorders | Non-systematic Assessment |
|
|
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| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D018942 | Macrolides |
| D007783 | Lactones |
| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|