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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000137-39 | EudraCT Number |
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The aims of the study was to evaluate the safety and efficacy of early introduction one month post-transplantation of everolimus associated to EC-MPS with tacrolimus discontinuation in de novo liver transplant recipients and to evaluate if it leads to a better renal function 6 month post-transplantation compared to standard treatment associating tacrolimus and EC-MPS.
The renal function was estimated by glomerular filtration rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus | Active Comparator | From transplantation to randomization: Basiliximab (40mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids |
|
| Everolimus (RAD001) | Experimental | From transplantation to randomization: Basiliximab (40mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus | Drug | Arm 1 : tacrolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to month 6 post-transplantation. Arm 2 : tacolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to 16 weeks post-transplantation at the latest. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (Randomization) in Renal Function | Change in renal function was measured by change in glomerular filtration rate (GFR). GFR calculated using the abbreviated modification of diet in renal disease (aMDRD) formula. GFR in mL/min/1.73m^2 for men of non-black ethnicity: 186 * [C/88]^-1.154 * [A]^-0.023*G*R ; C = serum creatinine (in μmol/L); A = Age (in years). G = 0.742 when the patient is a women; Otherwise G=1 R= 1.21 when the patient was of black ethnicity; Otherwise R = 1 Baseline was Day 28 visit. | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Treatment Failures | Incidence of treatment failures, assessed with composite criterion including treated biopsy proven acute rejection (tBPAR) with a rejection activity index (RAI) according to Banff classification >3, graft loss or death at 6 months. Biopsy proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted. The graft was presumed to be lost on the day the patient was registered again on the waiting list, or the day he/she received a new graft. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Besançon | 25030 | France | |||
| Novartis Investigative Site |
Total 188 patients were randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | Tacrolimus | From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
| everolimus | Drug | Arm 1: no everolimus Arm 2: everolimus (C0 6-10 ng/ml) from randomization to month 6 post-transplantation |
|
|
| Basiliximab | Drug | Basiliximab was supplied to the participating centers as marketed, i.e. in packs containing one vial of 20-mg powder, and water for injection (WFI). 20 mg at D0 and D4 |
|
|
| Mycophenolic Acid | Drug | Dose of 1440 mg/day from transplantation to month 6 post- transplantation |
|
|
| Corticosteroids | Drug | Administration of oral corticosteroid therapy was at the discretion of the centers according to their usual practice |
|
| At week 12 and week 24 |
| Number of Patients With Treated or Not Treated Biopsy Proven Acute Rejection (BPAR) | Biopsy proven acute rejection was defined as a clinically suspected acute rejection confirmed by biopsy. | at 12 week and 24 week |
| Number of Patients Reported With Different Categories of Severity of BPAR According to Banff Classification | Biopsy proven acute rejection was defined as a clinically suspected acute rejection confirmed by biopsy. The severity of BPAR was categorized as : Mild (Banff grade I, RAI = 4 and 5) Moderate (Banff grade II, RAI = 6 and 7) Severe (Banff grade III, RAI = 8 and 9) Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted. | at 12 week and 24 week |
| Number of Patients With Treated or Untreated BPAR With RAI Score Greater Than 3 | Biopsy proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted. The patients with treated or untreated BPAR having RAI score > 3 were reported in this end point. | At 24 weeks |
| Number of Patients With Death or Graft Loss | The graft was presumed to be lost on the day the patient was registered again on the waiting list, or the day he/she received a new graft. | at week 24 |
| Change From Baseline (Randomization) in Serum Creatinine | Change in serum creatinine concentrations from baseline (randomization) to week 24 post-randomization was one of the efficacy assessments of renal function. Baseline was Day 28 visit. | Baseline, Week 24 |
| Change From Baseline (Randomization) in Urine Protein/Creatinine Ratio | Change in urine protein/creatinine ratio from baseline (randomization) to week 24 post-randomization was one of the efficacy assessments of renal function. Baseline was Day 28 visit. | Baseline, week 24 |
| Change From Baseline (Randomization) in Creatinine Clearance Estimated Using the Adjusted Cockcroft-Gault Formula | Creatinine clearance by the Cockcroft-Gault formula is computed in mL/min/1.73m^2 from the creatinine clearance in mL/min by multiplying it by 1.73 and dividing it by the body surface area Baseline was Day 28 visit. | Baseline, Week 24 |
| Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by Abbreviated Modification of Diet in Renal Disease (MDRD) Formula | Change in glomerular filtration rate was calculated using the MDRD abbreviated formula. GFR in mL/min/1.73m^2 for men of non-black ethnicity: 186 * [C/88]^-1.154 * [A]^-0.023*G*R ; C = serum creatinine (in μmol/L); A = Age (in years). G = 0.742 when the patient is a women; Otherwise G=1 R= 1.21 when the patient was of black ethnicity; Otherwise R = 1 Baseline was Day 28 visit. | Baseline, Week 24 |
| Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by CKD-EPI Formula | GFR estimated by using the Chronic kidney disease- epidemiology (CKD-EPI) formula: eGFR (mL/min/1.73m^2) = 141 * min(C/K,1)^ α * max(C/K,1)^-1.209 * 0.993^A * 1.1018 (if male) * 1.159 (if black) where C = serum creatinine (in mg/dL) ; A = Age (in years); K = 0.7 for women and 0.9 for men; α = -0.329 for women and -0.411 for men. Baseline was Day 28 visit. | Baseline, Week 24 |
| Number of Patients in Different Stages of Chronic Kidney Diseases According to the K/DOQI Classification System | Kidney disease outcomes quality initiative (K/DOQI) classification is based on glomerular filtration rate (GFR), abbreviated MDRD formula (mL/min/1.73m^2) : Stage 1 : GFR >= 90; Stage 2 = GFR was between 60-89; Stage 3 = GFR was between 30-59 ; Stage 4 = GFR was between 15-29; Stage 5 = GFR was < 15 (or dialysis) | At Week 24 |
| Number of Patients With Any Adverse Events, Serious Adverse Events, Death and Premature Discontinuation | Baseline was Day 28 visit. This endpoint reports patients with total adverse events (any), serious adverse events, death and premature discontinuation. | Baseline to 24 weeks |
| Bordeaux |
| 33076 |
| France |
| Novartis Investigative Site | Chambray-lès-Tours | 37044 | France |
| Novartis Investigative Site | Clichy | 92110 | France |
| Novartis Investigative Site | Créteil | 94010 | France |
| Novartis Investigative Site | Grenoble | 38043 | France |
| Novartis Investigative Site | Lille | 59037 | France |
| Novartis Investigative Site | Marseille | 13385 | France |
| Novartis Investigative Site | Montpellier | 34295 | France |
| Novartis Investigative Site | Nice | 06202 | France |
| Novartis Investigative Site | Paris | 75651 | France |
| Novartis Investigative Site | Rennes | 35033 | France |
| Novartis Investigative Site | Toulouse | 31054 | France |
| Novartis Investigative Site | Villejuif | 94800 | France |
| Everolimus (RAD001) |
From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest). |
| Safety Set of Population |
|
| Intent to Treat Population |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Randomized population
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| ID | Title | Description |
|---|---|---|
| BG000 | Tacrolimus | From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids |
| BG001 | Everolimus (RAD001) | From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Change From Baseline (Randomization) in Renal Function | Change in renal function was measured by change in glomerular filtration rate (GFR). GFR calculated using the abbreviated modification of diet in renal disease (aMDRD) formula. GFR in mL/min/1.73m^2 for men of non-black ethnicity: 186 * [C/88]^-1.154 * [A]^-0.023*G*R ; C = serum creatinine (in μmol/L); A = Age (in years). G = 0.742 when the patient is a women; Otherwise G=1 R= 1.21 when the patient was of black ethnicity; Otherwise R = 1 Baseline was Day 28 visit. | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value a Day 28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data. | Posted | Least Squares Mean | Standard Error | mL/min/1.73m^2 | Baseline, Week 24 |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Treatment Failures | Incidence of treatment failures, assessed with composite criterion including treated biopsy proven acute rejection (tBPAR) with a rejection activity index (RAI) according to Banff classification >3, graft loss or death at 6 months. Biopsy proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted. The graft was presumed to be lost on the day the patient was registered again on the waiting list, or the day he/she received a new graft. | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at Day 28 and a posterior value were available. | Posted | Number | Patients | At week 12 and week 24 |
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| Secondary | Number of Patients With Treated or Not Treated Biopsy Proven Acute Rejection (BPAR) | Biopsy proven acute rejection was defined as a clinically suspected acute rejection confirmed by biopsy. | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at Day 28 and a posterior value were available. | Posted | Number | Patients | at 12 week and 24 week |
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| Secondary | Number of Patients Reported With Different Categories of Severity of BPAR According to Banff Classification | Biopsy proven acute rejection was defined as a clinically suspected acute rejection confirmed by biopsy. The severity of BPAR was categorized as : Mild (Banff grade I, RAI = 4 and 5) Moderate (Banff grade II, RAI = 6 and 7) Severe (Banff grade III, RAI = 8 and 9) Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted. | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at day 28 and a posterior value were available. | Posted | Number | Patients | at 12 week and 24 week |
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| Secondary | Number of Patients With Treated or Untreated BPAR With RAI Score Greater Than 3 | Biopsy proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted. The patients with treated or untreated BPAR having RAI score > 3 were reported in this end point. | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at day 28 and a posterior value were available. | Posted | Number | Patients | At 24 weeks |
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| Secondary | Number of Patients With Death or Graft Loss | The graft was presumed to be lost on the day the patient was registered again on the waiting list, or the day he/she received a new graft. | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at day 28 and a posterior value were available. | Posted | Number | Patients | at week 24 |
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| Secondary | Change From Baseline (Randomization) in Serum Creatinine | Change in serum creatinine concentrations from baseline (randomization) to week 24 post-randomization was one of the efficacy assessments of renal function. Baseline was Day 28 visit. | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data. | Posted | Mean | Standard Deviation | µmol/L | Baseline, Week 24 |
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| Secondary | Change From Baseline (Randomization) in Urine Protein/Creatinine Ratio | Change in urine protein/creatinine ratio from baseline (randomization) to week 24 post-randomization was one of the efficacy assessments of renal function. Baseline was Day 28 visit. | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom urine protein and creatinine value at day 28 and a posterior value were available. LOCF applied. | Posted | Mean | Standard Deviation | mg/mmol | Baseline, week 24 |
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| Secondary | Change From Baseline (Randomization) in Creatinine Clearance Estimated Using the Adjusted Cockcroft-Gault Formula | Creatinine clearance by the Cockcroft-Gault formula is computed in mL/min/1.73m^2 from the creatinine clearance in mL/min by multiplying it by 1.73 and dividing it by the body surface area Baseline was Day 28 visit. | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data. | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | Baseline, Week 24 |
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| Secondary | Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by Abbreviated Modification of Diet in Renal Disease (MDRD) Formula | Change in glomerular filtration rate was calculated using the MDRD abbreviated formula. GFR in mL/min/1.73m^2 for men of non-black ethnicity: 186 * [C/88]^-1.154 * [A]^-0.023*G*R ; C = serum creatinine (in μmol/L); A = Age (in years). G = 0.742 when the patient is a women; Otherwise G=1 R= 1.21 when the patient was of black ethnicity; Otherwise R = 1 Baseline was Day 28 visit. | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data. | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | Baseline, Week 24 |
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| Secondary | Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by CKD-EPI Formula | GFR estimated by using the Chronic kidney disease- epidemiology (CKD-EPI) formula: eGFR (mL/min/1.73m^2) = 141 * min(C/K,1)^ α * max(C/K,1)^-1.209 * 0.993^A * 1.1018 (if male) * 1.159 (if black) where C = serum creatinine (in mg/dL) ; A = Age (in years); K = 0.7 for women and 0.9 for men; α = -0.329 for women and -0.411 for men. Baseline was Day 28 visit. | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data. | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | Baseline, Week 24 |
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| Secondary | Number of Patients in Different Stages of Chronic Kidney Diseases According to the K/DOQI Classification System | Kidney disease outcomes quality initiative (K/DOQI) classification is based on glomerular filtration rate (GFR), abbreviated MDRD formula (mL/min/1.73m^2) : Stage 1 : GFR >= 90; Stage 2 = GFR was between 60-89; Stage 3 = GFR was between 30-59 ; Stage 4 = GFR was between 15-29; Stage 5 = GFR was < 15 (or dialysis) | ITT population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. | Posted | Number | Patients | At Week 24 |
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| Secondary | Number of Patients With Any Adverse Events, Serious Adverse Events, Death and Premature Discontinuation | Baseline was Day 28 visit. This endpoint reports patients with total adverse events (any), serious adverse events, death and premature discontinuation. | The safety population included all randomized patients who received at least one dose of study treatment post-randomization and for whom there was a post-treatment safety assessment. | Posted | Number | Patients | Baseline to 24 weeks |
|
Not provided
The safety population included all randomized patients who received at least one dose of study treatment post-randomization and for whom there was a post-treatment safety assessment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tacrolimus | From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids | 28 | 94 | 68 | 94 | ||
| EG001 | Everolimus (RAD001) | From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest). | 42 | 90 | 64 | 90 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 15.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Device dislocation | General disorders | 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 15.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 15.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | 15.1 | Systematic Assessment |
| |
| Hyperthermia | General disorders | 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 15.1 | Systematic Assessment |
| |
| Sudden death | General disorders | 15.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | 15.1 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | 15.1 | Systematic Assessment |
| |
| Biloma | Hepatobiliary disorders | 15.1 | Systematic Assessment |
| |
| Cholangiolitis | Hepatobiliary disorders | 15.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | 15.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | 15.1 | Systematic Assessment |
| |
| Hepatic artery stenosis | Hepatobiliary disorders | 15.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | 15.1 | Systematic Assessment |
| |
| Hepatic vein stenosis | Hepatobiliary disorders | 15.1 | Systematic Assessment |
| |
| Hepatic vein thrombosis | Hepatobiliary disorders | 15.1 | Systematic Assessment |
| |
| Hepatitis cholestatic | Hepatobiliary disorders | 15.1 | Systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | 15.1 | Systematic Assessment |
| |
| Hepatorenal syndrome | Hepatobiliary disorders | 15.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | 15.1 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | 15.1 | Systematic Assessment |
| |
| Nodular regenerative hyperplasia | Hepatobiliary disorders | 15.1 | Systematic Assessment |
| |
| Liver transplant rejection | Immune system disorders | 15.1 | Systematic Assessment |
| |
| Transplant rejection | Immune system disorders | 15.1 | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Abscess oral | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Cholangitis suppurative | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Hepatic infection | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Oral infection | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Pneumococcal infection | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Septic arthritis staphylococcal | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Sinusitis aspergillus | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Anastomotic stenosis | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
| |
| Biliary anastomosis complication | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
| |
| Liver graft loss | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
| |
| Post procedural bile leak | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
| |
| Wound evisceration | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 15.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
| |
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
| |
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | 15.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 15.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 15.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | 15.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | 15.1 | Systematic Assessment |
| |
| Physical disability | Social circumstances | 15.1 | Systematic Assessment |
| |
| Diabetes mellitus management | Surgical and medical procedures | 15.1 | Systematic Assessment |
| |
| Drain removal | Surgical and medical procedures | 15.1 | Systematic Assessment |
| |
| Umbilical hernia repair | Surgical and medical procedures | 15.1 | Systematic Assessment |
| |
| Arterial stenosis | Vascular disorders | 15.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 15.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 15.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | 15.1 | Systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 15.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 15.1 | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | trialandresults.registries@novartis.com |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D000068338 | Everolimus |
| D000077552 | Basiliximab |
| D009173 | Mycophenolic Acid |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D020123 | Sirolimus |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| Male |
|
| Everolimus (RAD001) |
From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest). |
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From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.
From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest).
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