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This study will compare the following immunosuppressive regimens in recipients of kidney transplantation: A) everolimus, cyclosporine and steroids given once-a-day; B) everolimus and cyclosporine given twice a day with steroid withdrawal; C) everolimus, cyclosporine given twice a day and continuous steroids. The purpose of this study is to evaluate regimens A and B in comparison with the control group (group C) for efficacy, using as main endpoint the treatment failure rate, a composite endpoint including death, graft loss, BPAR and lost to follow-up between randomization and Month 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A -Once-a-day regimen | Experimental | Everolimus: in patients randomized to Group A before Amendment 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12. Cyclosporine: in patients randomized to Group A before Amendment 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL. Prednisone: In patients randomized to Group A before Amendment 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning. |
|
| Group B - Steroid Withdrawal group | Experimental | Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12. Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12. Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks. |
|
| Group C - Standard twice-a-day group | Active Comparator | Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12. Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12. Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| everolimus | Drug | Everolimus (Certican®) was provided in blisters containing tablets of 0.25 mg and 0.75 mg. Everolimus was initiated within 48 hours after graft reperfusion and it was administered orally. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Failure Rate | Occurrence or not of treatment failure in each patient. Treatment failure was defined as a composite endpoint of biopsy-proven acute rejection (a biopsy graded IA, IB, IIA, IIB or III according to Banff '97 grading with 2007 update), graft loss, death or lost to follow-up occurring after randomization (V5) and within M12 (V9). | Between randomization (Month 3) and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Estimated Glomerular Filtration Rate (eGFR) Between Randomization (Month 3) and Month 12 | eGFR by Nankivell, in terms of descriptive statistics and change vs randomization visit - to compare the changes in the estimated GFR (Nankivell) between randomization and Month 12 in the steroid withdrawal group (Group B) to the change observed in the standard twice-a-day group (Group C), for non-inferiority |
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Inclusion criteria:
Exclusion criteria:
Exclusion criteria at screening (pre-transplantation, Visit 1):
Additional exclusion criteria post-transplantation (Visit 2):
• graft not perfused or with thrombosis of the main vessels, according to angioscintigraphy or echocolordoppler within 48 hours after the end of surgical procedure
To avoid any possible influence of the confounding factors on the results of this study additional exclusion criteria at randomization were (Visit 5, Month 3):
unsatisfactory renal function (CrCl according Cockcroft and Gault<40 mL/min)
proteinuria ≥0.8 g/24 hrs
steroid-resistant, humoral, moderate/severe (BANFF grade ≥II) biopsy proven acute rejections
multiple (2 or more) biopsy proven or treated acute rejections or acute rejections leading to relevant loss of renal function
acute rejection or impairment of renal function (increase of serum creatinine>30%) in the month preceding randomization
severe/uncontrollable adverse events with suspected relationship to everolimus (e.g. anemia, oral aphtosis, arthralgia) for the control of which the investigator has planned the withdrawal of everolimus
severe infections requiring hospitalization in the two weeks preceding randomization
poor compliance to prescribed treatments
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Perugia | Perugia | 06070 | Italy | ||
| Novartis Investigative Site |
During the Pre-randomization Period all patients received the same treatments. At V5 eligible patients were randomized 1:1:1 to one of the treatment arms and entered the Randomized Treatment Period. After Amendment 1 approval, randomization to once-a-day regimen group was stopped and patients were randomized 1:1 to Group B or Group C.
A total of 332 patients were screened. 330 were pre-randomized, 2 were not. Additionally, 2 pts were not treated which made the safety/ITT population 328. Of the 328, 184 were randomized and 144 were not. Of the 144, 70 dropped before day 90 & 74 completed the pre-rand period but were not randomized because they were not eligible for randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-randomized: Not-randomization Patients (NRP) | At the Baseline visit, performed up to 48 hours after graft reperfusion, eligible patients entered the Pre-Randomization Period and started study drug treatment (D1 = 1st day of everolimus treatment). Not-randomization Patients (NRP) was defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as "not randomized patients" (NRP) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Pre-randomization Period (Day 1 to 90) |
|
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|
| Not Randomized Population (NRP) | Experimental | NRP defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as "not randomized patients" (NRP) and described with respect to baseline characteristics, treatment and outcome variables. |
|
|
| cyclosporine | Drug | Cyclosporine for microemulsion (CsA, Sandimmun® Neoral®) was coadministered with everolimus at the same time of the day. CsA was available in alu-alu blisters containing soft gelatine capsules of 100 mg, 50 mg, 25 mg and 10 mg. Oral solution, as bottles containing 50 mL of solution (100 mg/mL) has been provided and used in case the drug had been administered to patients by nasogastric tube immediately after transplant. |
|
|
| Prednison (continuous steroids) | Drug | continuous steroids |
|
| Month 3 to Month 12 |
| Biopsy Proven Acute Rejection (BPAR) Rate Between Randomization and Month 12 | Occurrence of BPAR (after randomization) between arm B (steroid withdrawal group) and arm c (standard twice-a-day group). BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III according to Banff 1997 grading with 2007 update. | Month 3 to Month 12 |
| Number of Participants With Graft and Patient Survival After Randomization | Graft Survival, calculated from the date of transplantation to the date of irreversible graft failure signified by return to long-term retransplantation or the date of the last follow-up during the period when the transplant was still functioning or to the date of death. Patient survival, calculated from the date of transplantation to the date of death or the date of the last follow-up. | Month 3 to Month 12 |
| Change in Estimated Creatine Clearance | At each visit, estimated creatinine clearance was measured in the local laboratory to analyze the evolution of the renal function. The following indirect measures of renal function were computed: estimated creatinine clearance according to Cockcroft and Gault formula and MDRD formula. | M3, M12 |
| Change in Serum Creatinine | Serum creatinine (a blood measurement) is an important indicator of renal health because it is an easily-measured by-product of muscle metabolism. Measuring serum creatinine is a simple test and it is the most commonly used indicator of renal function. | M3, M12 |
| Sassari |
| Sassari |
| 07100 |
| Italy |
| Novartis Investigative Site | Ancona | 60100 | Italy |
| Novartis Investigative Site | Bologna | Italy |
| Novartis Investigative Site | Brescia | Italy |
| Novartis Investigative Site | Cagliari | Italy |
| Novartis Investigative Site | Catania | Italy |
| Novartis Investigative Site | Coppito | Italy |
| Novartis Investigative Site | Florence | Italy |
| Novartis Investigative Site | Genova | 16132 | Italy |
| Novartis Investigative Site | Milan | 20122 | Italy |
| Novartis Investigative Site | Modena | 41100 | Italy |
| Novartis Investigative Site | Naples | Italy |
| Novartis Investigative Site | Novara | 28100 | Italy |
| Novartis Investigative Site | Padova | Italy |
| Novartis Investigative Site | Palermo | Italy |
| Novartis Investigative Site | Parma | Italy |
| Novarits Investigative Site | Pisa | Italy |
| Novartis Investigative Site | Roma | Italy |
| Novartis Investigative Site | Rome | Italy |
| Novartis Investigative Site | Salerno | Italy |
| Novartis Investigative Site | Siena | 53100 | Italy |
| Novartis Investigative Site | Torino | 10126 | Italy |
| Novartis Investigative Site | Treviso | Italy |
| Novartis InvestigativeSite | Udine | Italy |
| Novartis Investigative Site | Varese | Italy |
| Novartis Investigative Site | Verona | Italy |
| Novartis Investigative Site | Vicenza | Italy |
| FG001 | Randomized: Group A - Once-a-day Regimen | Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size. Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12. Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL. Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning. |
| FG002 | Randomized: Group B - Steroid Withdrawal Group | Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12. Cyclosporine: after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12. Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks. |
| FG003 | Randomized: Group C - Standard Twice-a-day Group | Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12. Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12. Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Randomized Period (Day 90 to Month 12) |
|
|
Safety Population: The Safety Population (SAF population) includes all patients who signed an informed consent, performed renal transplantation and received at least one dose of study drug (everolimus).
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| ID | Title | Description |
|---|---|---|
| BG000 | Not Randomized Population (NRP) | At the Baseline visit, performed up to 48 hours after graft reperfusion, eligible patients entered the Pre-Randomization Period and started study drug treatment (D1 = 1st day of everolimus treatment). Not-randomization Patients (NRP) was defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as "not randomized patients" (NRP) |
| BG001 | Group A - Once-a-day Regimen | Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size. Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12. Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL. Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning. |
| BG002 | Group B - Steroid Withdrawal Group | Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12. Cyclosporine: after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12. Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks. |
| BG003 | Group C - Standard Twice-a-day Group | Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12. Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12. Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning. |
| BG004 | 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Smoking Status | Number | Participants |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Female reproductive status | Number | Participants |
| ||||||||||||||||
| Result of HCG pregnancy screen - Negative | Number | 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 | Treatment Failure Rate | Occurrence or not of treatment failure in each patient. Treatment failure was defined as a composite endpoint of biopsy-proven acute rejection (a biopsy graded IA, IB, IIA, IIB or III according to Banff '97 grading with 2007 update), graft loss, death or lost to follow-up occurring after randomization (V5) and within M12 (V9). | ITT population: all randomized pts who received at least one dose of study drug after Visit 5 & have at least one post-baseline assessment of the primary efficacy variable. Change in study design stopped the randomization into Group A, due to overall slow enrollment rate & shifted all relative objectives to exploratory, due to small sample size. | Posted | Number | Participants | Between randomization (Month 3) and Month 12 |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Changes in the Estimated Glomerular Filtration Rate (eGFR) Between Randomization (Month 3) and Month 12 | eGFR by Nankivell, in terms of descriptive statistics and change vs randomization visit - to compare the changes in the estimated GFR (Nankivell) between randomization and Month 12 in the steroid withdrawal group (Group B) to the change observed in the standard twice-a-day group (Group C), for non-inferiority | ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure). | Posted | Mean | Standard Deviation | mL/min | Month 3 to Month 12 |
| |||||||||||||||||||||||||||||||||
| Secondary | Biopsy Proven Acute Rejection (BPAR) Rate Between Randomization and Month 12 | Occurrence of BPAR (after randomization) between arm B (steroid withdrawal group) and arm c (standard twice-a-day group). BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III according to Banff 1997 grading with 2007 update. | ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure). | Posted | Number | Participants | Month 3 to Month 12 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Graft and Patient Survival After Randomization | Graft Survival, calculated from the date of transplantation to the date of irreversible graft failure signified by return to long-term retransplantation or the date of the last follow-up during the period when the transplant was still functioning or to the date of death. Patient survival, calculated from the date of transplantation to the date of death or the date of the last follow-up. | ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure). | Posted | Number | Participants | Month 3 to Month 12 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in Estimated Creatine Clearance | At each visit, estimated creatinine clearance was measured in the local laboratory to analyze the evolution of the renal function. The following indirect measures of renal function were computed: estimated creatinine clearance according to Cockcroft and Gault formula and MDRD formula. | ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure). | Posted | Mean | Standard Deviation | mL/min | M3, M12 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Serum Creatinine | Serum creatinine (a blood measurement) is an important indicator of renal health because it is an easily-measured by-product of muscle metabolism. Measuring serum creatinine is a simple test and it is the most commonly used indicator of renal function. | ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure). | Posted | Mean | Standard Deviation | mg/dL | M3, M12 |
|
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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 | Not Randomized Population (NRP) | At the Baseline visit, performed up to 48 hours after graft reperfusion, eligible patients entered the Pre-Randomization Period and started study drug treatment (D1 = 1st day of everolimus treatment). This population defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as "not randomized patients" (NRP) and described with respect to baseline characteristics, treatment and outcome variables. | 65 | 144 | 108 | 144 | ||
| EG001 | Group A - Once-a-day Regimen | Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size. Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12. Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL. Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning. | 18 | 45 | 35 | 45 | ||
| EG002 | Group B - Steroid Withdrawal Group | Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12. Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12. Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks. | 24 | 68 | 56 | 68 | ||
| EG003 | Group C - Standard Twice-a-day Group | Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12. Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12. Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning. | 25 | 71 | 57 | 71 |
| 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 |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Localised intraabdominal fluid collection | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Device occlusion | General disorders | MedDRA | Systematic Assessment |
| |
| Hyperpyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA | Systematic Assessment |
| |
| Implant site haematoma | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Kidney transplant rejection | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Transplant rejection | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bacterial pyelonephritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Human polyomavirus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lobar 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 |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Graft loss | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Graft thrombosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Perirenal haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Urinary anastomotic leak | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Vascular graft complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal artery dissection | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal artery thrombosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal cortical necrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal vein thrombosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Ureteral necrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Ureteric dilatation | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Ureteric fistula | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary fistula | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Bladder operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Nephrostomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Ureteral stent removal | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Urinary tract operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Intra-abdominal haematoma | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Lymphorrhoea | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Thrombophlebitis superficial | 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 |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Fluid retention | 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 |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypocalcaemia | 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 |
| |
| Renal impairment | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular 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 |
| 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 |
Not provided
Not provided
| Lost to Follow-up |
|
| Administrative Problems |
|
| Graft Loss |
|
| Male |
|
| Black |
|
| Oriental |
|
| Other |
|
| Yes |
|
| Missing |
|
| Surgically sterilised |
|
| Postmenopausal |
|
| Missing |
|
|
|
|
|
|
|
|
|
|
|