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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000771-42 | EudraCT Number |
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This study is designed to evaluate if early conversion to everolimus from cyclosporine in de novo renal transplant recipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus (CNI-free) | Experimental | Patients in this group were converted to everolimus immunosuppressive therapy. The patients in the everolimus group were treated with everolimus, off-label (CNI-free) use, and EC-MPS and corticosteroids in accordance with local practice and approved label. Conversion to everolimus was as follows: Day 1: begin everolimus 3 mg in the evening. Usual morning dose of CsA and 50% reduced evening dose of CsA Day 2: everolimus 2 mg in the morning and 2 mg in the evening, complete discontinuation of CsA Day 3 or 4, and onwards: everolimus according to trough level 6-10 ng/mL.The given total daily dose of the immunosuppressive drugs (everolimus) was divided into two (equal) doses, applied 12 hours apart. |
|
| Control (CsA) | Active Comparator | Patients in the control group continued on an immunosuppressive regimen. The patients in this Control group were treated with CsA, EC-MPS and corticosteroids in accordance with local practice and approved label. The given total daily dose of the immunosuppressive drugs (CsA and EC-MPS) was divided into two (equal) doses, applied 12 hours apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| everolimus | Drug | Everolimus (Certican®) tablets administered orally in two divided doses (b.i.d.) at a starting dose of 4 mg/day adjusted to target a trough blood concentration between 6 and 10 ng/mL in period 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Measured Glomerular Filtration Rate | To compare the efficacy between treatment regimens by assessing the difference in renal function evaluated by mean measured glomerular filtration rate (mGFR) 12 months after renal transplantation (TX). The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Measured Glomerular Filtration Rate | Progression of renal function measured by mean mGFR at 36 months after renal TX. The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice. | Month 36 |
| Calculated Glomerular Filtration Rate |
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Inclusion Criteria:
Exclusion criteria
In addition to the above criteria the following must be met at time of randomization:
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Aarhus N | 8200 | Denmark | |||
| Novartis Investigative Site |
The study consisted of 2 periods, period 1: TX to Week 7 ± 7 days post-TX and period 2: Week 7 ± 7 days post-TX to Month 36. 341 patients were enrolled in this study. 204 randomized to receive study treatment: 104 in the everolimus group, 100 in the control group. 2 patients in everolimus group did not receive at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Everolimus (CNI-free) | This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 - Pre-Randomization |
|
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| cyclosporine A | Drug | CsA (Sandimmun Neoral), based on C0-h levels 75-200 ng/mL or C2-h levels 700 900 ng/mL from randomization to Month 6, or C0-h levels 50-150 ng/mL or C2-h levels 600 800 ng/mL from Month 6 to Month 36, according to local method |
|
|
| Enteric Coated Mycophenolate Sodium (EC-MPS) | Drug | Target dose 1440 mg in the control group, target dose 1080 in the everolimus group (higher dose in the CsA group because of interactions of CsA on gastric reabsorption of mycophenolate) |
|
|
| corticosteroids | Drug | For both groups: minimum corticosteroid dose of 10 mg until week 12, 5-10 mg until month 12, month 12-36 corticosteroid treatment on investigator's descretion. |
|
|
| Basiliximab | Drug | Induction therapy 20 mg basiliximab on Day 0 prior to reperfusion and 20 mg on Day 4 post-TX. |
|
|
The GFR was calculated according to the Modification of Diet in Renal Disease Study Group (MDRD) method, the Cockcroft-Gault method, and the Nankivell formula. cGFR was calculated from blood samples collected at predefined time points. |
| Months 12, 36 |
| Progression of Measured Glomerular Filtration Rate | Change in renal progression measured by mean mGFR from week 7 to Month 36 | Week 7, Week 52, Month 36 |
| Percentage of Participants Who Developed CAN (Chronic Allograft Nephropathy) | Assessed by protocol biopsies findings (Banff 1997 lesion scores and morphometry of the interstitial space) | Month 12, Month 36 |
| Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) | A BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III (Banff 97 classification). Biopsy graded IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells). Biopsy grade IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells). Biopsy grade IIA: Mild to moderate intimal arteritis. Biopsy graded IIB: Severe intimal arteritis comprising > 25% of the lumenal area. | Months 12, 24, 36 |
| Percentage of Participants With Graft Loss or Death | The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, the day of nephrectomy was the day of graft loss. Graft loss was considered an SAE (serious adverse event). | Months 12, 24, 36 |
| Time to Treatment Failure | Treatment failure was defined as graft loss or death.Time to treatment failure is shown as mean time to treatment failure. | Months 12, 24, 36 |
| Percentage of Participants With Treatment Failures | Treatment failure was defined as graft loss or death. | Months 12, 24, 36 |
| Time to First Malignancy | This is the time to first diagnosed malignancy. Malignancies (skin- or solid cancer) were listed whether they reoccurred in situ, were metastatic or de novo. This is shown as mean time. | Months 12, 24, 36 |
| Lipid Profile for Apolipoprotein | Blood lipid levels of patients in both groups for Apolipoprotein (Apo) A1 and B. | Months 12, 24, 36 |
| Lipid Profile for HDL-C, LDL-C,Total Cholesterol, and Triglycerides | Blood lipid levels of patients in both groups: HDL-C, LDL-C,Total cholesterol, and triglycerides. | Months 12, 24, 36 |
| Number of Lipid-lowering Drugs Taken | Months 12, 24, 36 |
| Percentage of Participants on Lipid-lowering Drugs | Months 12, 24, 36 |
| Number of Antihypertensive Drugs Taken | Months 12, 24, 36 |
| Percentage of Participants on Antihypertensive Drugs | Months 12, 24, 36 |
| Proteinuria (Measured as Urine Albumin/Creatinine Ratio (mg/mmol)) | Proteinuria is when a large amount of protein, that should remain circulating in a person's blood, is "spilled" into their urine and eliminated from the body. | Months 12, 24, 36 |
| Percentage of Participants Who Had Donor Specific Antibodies (DSA) | Venous blood was drawn for donor specific (DSA) measurements prior to transplantation and at the final visit (36 months). The blood sample was first screened for the presence of PRA i.e. donor specific Immunoglobulin-G antibodies against specific HLA antigens. If PRA antibodies were detected, the blood sample was tested for specific DSAs on single antigen Luminex beads (coated with single HLA class I or II molecules). In this way, the specificity of these antibodies could be determined. | Month 36 |
| Health-related Quality of Life (QoL) as Measured by EuroQoL EQ-5D | Health-related QoL was assessed using the EQ-5D questionnaire. The EQ-5D self-report questionnaire consists of the EQ-5D descriptive system that measures health-related quality of life on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity (no problems/moderate problems/severe problems) within a particular EQ-5D dimension. Scores are transformed to a range of 0-1, in which higher scores reflect better health status. | Before randomization, Months 12, 36 |
| Copenhagen |
| DK-2100 |
| Denmark |
| Novartis Investigative Site | Herlev | 2730 | Denmark |
| Novartis Investigative Site | Odense C | DK-5000 | Denmark |
| Novartis Investigative Site | Oslo | 0424 | Norway |
| Novartis Investigative Site | Gothenburg | 413 45 | Sweden |
| Novartis Investigative Site | Malmö | 205 02 | Sweden |
| Novartis Investigative Site | Uppsala | 751 85 | Sweden |
| FG001 | Control (CsA) | All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period. |
| FG002 | Pre-Randomized Patients | All patients received induction therapy with 20 mg basiliximab on Day 0 prior to reperfusion and 20 mg at Day 4 post-TX (transplatation), and commenced on an immunosuppressive regimen consisting of: CsA (based on trough levels C0-h 100-250 ng/mL or C2-h 900 1300 ng/mL, according to local method), EC MPS (target dose 1440 mg/day, minimum dose 1080 mg/day at the time of randomization), Corticosteroids (a minimum dose of 10 mg prednisolone or equivalent was given at time of randomization). |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Period 2 - Post-Randomization |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Everolimus (CNI-free) | This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus. |
| BG001 | Control (CsA) | All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period. |
| BG002 | Not Randomized Patients | This group included patients in whom a renal TX was performed but who did not qualify for randomization at Visit 2. This group was to be described with respect to treatment, reason for not randomized and outcome variables calculated or measured GFR, whichever was feasible, BPAR, graft loss or death at 12 months (no outcome variables were collected for this population |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
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| 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 | Measured Glomerular Filtration Rate | To compare the efficacy between treatment regimens by assessing the difference in renal function evaluated by mean measured glomerular filtration rate (mGFR) 12 months after renal transplantation (TX). The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice. | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | Month 12 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Measured Glomerular Filtration Rate | Progression of renal function measured by mean mGFR at 36 months after renal TX. The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice. | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). Patients who did not provide mGFR assessment at M36 visit were excluded from the analysis. | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | Month 36 |
| ||||||||||||||||||||||||||||||
| Secondary | Calculated Glomerular Filtration Rate | The GFR was calculated according to the Modification of Diet in Renal Disease Study Group (MDRD) method, the Cockcroft-Gault method, and the Nankivell formula. cGFR was calculated from blood samples collected at predefined time points. | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | Months 12, 36 |
| ||||||||||||||||||||||||||||||
| Secondary | Progression of Measured Glomerular Filtration Rate | Change in renal progression measured by mean mGFR from week 7 to Month 36 | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | Week 7, Week 52, Month 36 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Developed CAN (Chronic Allograft Nephropathy) | Assessed by protocol biopsies findings (Banff 1997 lesion scores and morphometry of the interstitial space) | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Posted | Number | Percentage of participants | Month 12, Month 36 |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) | A BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III (Banff 97 classification). Biopsy graded IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells). Biopsy grade IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells). Biopsy grade IIA: Mild to moderate intimal arteritis. Biopsy graded IIB: Severe intimal arteritis comprising > 25% of the lumenal area. | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Posted | Number | Percentage of participants | Months 12, 24, 36 |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Graft Loss or Death | The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, the day of nephrectomy was the day of graft loss. Graft loss was considered an SAE (serious adverse event). | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Posted | Number | Percentage of participants | Months 12, 24, 36 |
| |||||||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure | Treatment failure was defined as graft loss or death.Time to treatment failure is shown as mean time to treatment failure. | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Posted | Mean | Standard Error | Days | Months 12, 24, 36 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Failures | Treatment failure was defined as graft loss or death. | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Posted | Number | Percentage of participants | Months 12, 24, 36 |
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| Secondary | Time to First Malignancy | This is the time to first diagnosed malignancy. Malignancies (skin- or solid cancer) were listed whether they reoccurred in situ, were metastatic or de novo. This is shown as mean time. | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Posted | Mean | Standard Error | Months | Months 12, 24, 36 |
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| Secondary | Lipid Profile for Apolipoprotein | Blood lipid levels of patients in both groups for Apolipoprotein (Apo) A1 and B. | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Posted | Mean | Standard Deviation | g/L | Months 12, 24, 36 |
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| Secondary | Lipid Profile for HDL-C, LDL-C,Total Cholesterol, and Triglycerides | Blood lipid levels of patients in both groups: HDL-C, LDL-C,Total cholesterol, and triglycerides. | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Posted | Mean | Standard Deviation | mmol/L | Months 12, 24, 36 |
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| Secondary | Number of Lipid-lowering Drugs Taken | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Posted | Mean | Standard Deviation | Number of lipid-lowering drugs | Months 12, 24, 36 |
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| Secondary | Percentage of Participants on Lipid-lowering Drugs | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Posted | Number | Percentage of participants | Months 12, 24, 36 |
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| Secondary | Number of Antihypertensive Drugs Taken | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Posted | Mean | Standard Deviation | Number of antihypertensive dugs | Months 12, 24, 36 |
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| Secondary | Percentage of Participants on Antihypertensive Drugs | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Posted | Number | Percentage of participants | Months 12, 24, 36 |
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| Secondary | Proteinuria (Measured as Urine Albumin/Creatinine Ratio (mg/mmol)) | Proteinuria is when a large amount of protein, that should remain circulating in a person's blood, is "spilled" into their urine and eliminated from the body. | The safety population (SAF) consists of all patients in whom TX was performed and who were randomized and treated with at least one dose of randomized treatment. | Posted | Mean | Standard Deviation | mg/mmol | Months 12, 24, 36 |
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| Secondary | Percentage of Participants Who Had Donor Specific Antibodies (DSA) | Venous blood was drawn for donor specific (DSA) measurements prior to transplantation and at the final visit (36 months). The blood sample was first screened for the presence of PRA i.e. donor specific Immunoglobulin-G antibodies against specific HLA antigens. If PRA antibodies were detected, the blood sample was tested for specific DSAs on single antigen Luminex beads (coated with single HLA class I or II molecules). In this way, the specificity of these antibodies could be determined. | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Posted | Number | Percentage of participants | Month 36 |
| |||||||||||||||||||||||||||||||
| Secondary | Health-related Quality of Life (QoL) as Measured by EuroQoL EQ-5D | Health-related QoL was assessed using the EQ-5D questionnaire. The EQ-5D self-report questionnaire consists of the EQ-5D descriptive system that measures health-related quality of life on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity (no problems/moderate problems/severe problems) within a particular EQ-5D dimension. Scores are transformed to a range of 0-1, in which higher scores reflect better health status. | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Posted | Mean | Standard Deviation | scores on a scale | Before randomization, Months 12, 36 |
|
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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 | Control (CsA) | All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period. | 65 | 100 | 88 | 100 | ||
| EG001 | Everolimus (CNI-free) | This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus. | 72 | 102 | 93 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Polycystic liver disease | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diabetic gastroparesis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Death | General disorders | MedDRA | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA | Systematic Assessment |
| |
| Metaplasia | General disorders | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Transplant rejection | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Clostridium colitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cytomegalovirus gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Epstein-Barr viraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis caliciviral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infected lymphocele | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Renal cyst infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Complications of transplant surgery | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Graft complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Poisoning | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Postoperative fever | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
| |
| Norovirus test positive | Investigations | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Encephalitis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Bladder perforation | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Glomerulonephritis rapidly progressive | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Breast enlargement | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Manual lymphatic drainage | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Nephrectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Transurethral prostatectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Vesicoureteral reflux surgery | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Arterial stenosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gingival hyperplasia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
| |
| Polyomavirus test positive | Investigations | MedDRA | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hirsutism | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA | 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 |
|---|---|
| D000068338 | Everolimus |
| D016572 | Cyclosporine |
| D009173 | Mycophenolic Acid |
| D000305 | Adrenal Cortex Hormones |
| D011239 | Prednisolone |
| D000077552 | Basiliximab |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Death |
|
| consent withdrawal, non compliance |
|
| Patients did not receive study drug |
|
| Male |
|
| Black |
|
| Oriental |
|
|
|
|
|
|
|
|
|
All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period. |
|
|
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|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period. |
|
|