Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024381-21 | EudraCT Number |
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The purpose of this study is to determine if everolimus combined with reduced exposure CNI (TAC) is efficacious and safe and will support corticosteroid elimination compared to a standard exposure CNI (TAC) + MMF + steroid regimen after paediatric kidney transplantation. An additional purpose of the study is to assess the effect of the combination of EVR and reduced exposure CNI (TAC) on renal function.
This study is part of the requirements of the Paediatric Investigational Plan approved by Paediatric Committee at the European Medicines Agency (PDCO/EMA) on September 10, 2010, and is intended to support the indication of everolimus in the prevention of acute rejection in paediatric recipients of a renal transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational arm | Experimental | Conversion from MMF to everolimus plus reduced dose tacrolimus and steroids withdrawal at 6 months after transplant |
|
| Control arm | Active Comparator | MMF continuation (in combination with tacrolimus and standard dose steroids) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAD001 | Drug | Everolimus (C0 trough level of 3-8 ng/mL) in combination with reduced dose tacrolimus and steroids withdrawal at 6 months after transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Having Reached the Composite Efficacy Endpoint of Biopsy-proven Acute Rejection | To estimate the rate of the composite efficacy endpoint of biopsy-proven acute rejection (BPAR), graft loss or death at 12 months post transplantation in primary paediatric kidney transplant recipients converted at 4-6 weeks post-transplantation from MMF + standard TAC regimen and steroids, to everolimus + reduced dose TAC regimen and steroid withdrawal at 6 months, versus continuation of MMF + standard TAC regimen and steroids. | 12 months, 36 months |
| To Evaluate Renal Function, Assessed by Glomerular Filtration Rate (eGFR) and Estimated by the Schwartz Formula (Abbreviated), at Month 12 and 36 | To evaluate renal function assessed by Glomerular Filtration Rate (eGFR) estimated by the Schwartz Formula (abbreviated) (Schwartz, 2009). | 12 months and 36 months post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Efficacy Endpoint | To evaluate the proportion of patients with the following efficacy events: Biopsy Proven Acute Rejection (BPAR), graft loss or death. The efficacy events will be descriptively summarized by treatment group. | at 12 and 36 months post-transplantation |
| To Evaluate the Severity of BPAR (Acute T-cell Mediated Rejection Only) (Banff 2009) |
Not provided
Inclusion Criteria:
Inclusion criteria at baseline:
Inclusion criteria at randomization:
Exclusion Criteria:
Exclusion criteria at baseline:
Exclusion criteria at randomization:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Los Angeles | California | 90095-1752 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36264431 | Derived | Patry C, Sauer LD, Sander A, Krupka K, Fichtner A, Brezinski J, Geissbuhler Y, Aubrun E, Grinienko A, Strologo LD, Haffner D, Oh J, Grenda R, Pape L, Topaloglu R, Weber LT, Bouts A, Kim JJ, Prytula A, Konig J, Shenoy M, Hocker B, Tonshoff B. Emulation of the control cohort of a randomized controlled trial in pediatric kidney transplantation with Real-World Data from the CERTAIN Registry. Pediatr Nephrol. 2023 May;38(5):1621-1632. doi: 10.1007/s00467-022-05777-x. Epub 2022 Oct 20. | |
| 32406111 |
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Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Full Analysis set (FAS) 106 enrolled and randomized patients except misrandomized Per Protocol set (PPS) 90 patients in the FAS without major protocol deviations Safety set (SAF) 106 randomized patients who received at least one dose of study drug
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | EVR+rTAC | Investigational arm : Conversion from MMF to everolimus plus reduced dose tacrolimus and steroids withdrawal at 6 months after transplant |
| FG001 | MMF+sTAC | Control arm : MMF continuation (in combination with tacrolimus and standard dose steroids) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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| MMF | Drug | MMF (Cellcept®): 600mg/m2/dose twice daily (1200 mg/m2/day) in combination with tacrolimus (Prograf) and standard dose steroids |
|
T-cell mediated rejection severity : Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells). Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells). Type IIA - Mild to moderate intimal arteritis Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation) |
| month 12, month 36 |
| To Evaluate the Time to Event of BPAR | Time to incidence of Event, given in terms of number of participants with an Event according to time interval up to 36 months | 36 months |
| Incidence of Biopsy Proven Antibody Mediated Rejection. | To evaluate the proportion of patients with the following efficacy events: biopsy proven antibody mediated rejection/Steroid resistant BPAR and BPAR treated with T cell depleting therapy. | at 12 and 36 months post-transplantation |
| Chronic Allograft Nephropathy / Interstitial Fibrosis and Tubular Atrophy | To evaluate the proportion of patients with chronic allograft nephropathy (interstitial fibrosis and tubular atrophy, IF/TA) by histopathology and its progression.The term chronic allograft nephropathy was used inappropriately in the protocol and therefore, replaced by interstitial fibrosis and tubular atrophy | at 12 and 36 months post-transplantation. |
| Proteinuria (Urinary Protein/Creatinine Ratio) | The urinary protein/creatinine ratio will be descriptively summarized by treatment group at each visit. The incidence rate of patients with proteinuria will be categorized in <0.2 g/mg/mg, 0.2<2.0 mg/mg and ≥ 2.0 mg/mg and summarized by treatment groups at each visit. | at 12 and 36 months post-transplantation |
| Growth/Development : Weight, Height, BMI : Change From Baseline | Evaluation of the potential effects upon the bone growth. The Z-score is a statistical tool which helps to assess data (here child growth parameters) relative to a reference or standard population. The Z-score describes the distance and direction of an observation away from the population median (or mean, however, here the median was used). A negative Z-score shows that data are lower than the median of the standard population, a positive Z-score shows that data are higher than the median of the standard population, and a Z-score of zero shows that the data are equal to the median of the standard population. The more the Z-score is distant from 0, the more expressed is for example underweight or overweight. | month 12 , month 36 post transplantation. |
| Evaluation of Evolution of Renal Allograft Function Over Time | results given as eGFR values by time interval | baseline, 6 months, 12 months , 24 months, 36 months |
| To Evaluate Renal Function, Assessed by Glomerular Filtration Rate (eGFR) and Estimated by the Schwartz Formula (Extended), at Month 12 | To evaluate renal function assessed by Glomerular Filtration Rate (eGFR) estimated by the Schwartz Formula (extended) (Schwartz, 2009). Results given as change from randomization | 12 months post-transplantation |
| Ann Arbor |
| Michigan |
| 48109-0331 |
| United States |
| Novartis Investigative Site | St Louis | Missouri | 63110 | United States |
| Novartis Investigative Site | Santa Fe | S3000EPV | Argentina |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 04038-002 | Brazil |
| Novartis Investigative Site | Bron | 69677 | France |
| Novartis Investigative Site | Lille | 59000 | France |
| Novartis Investigative Site | Paris | 75015 | France |
| Novartis Investigative Site | Paris | 75019 | France |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| Novartis Investigative Site | Tübingen | 72076 | Germany |
| Novartis Investigative Site | Budapest | 1082 | Hungary |
| Novartis Investigative Site | Bologna | BO | 40138 | Italy |
| Novartis Investigative Site | Genova | GE | 16147 | Italy |
| Novartis Investigative Site | Roma | ITA | 00165 | Italy |
| Novartis Investigative Site | Padova | PD | 35128 | Italy |
| Novartis Investigative Site | Torino | TO | 10126 | Italy |
| Novartis Investigative Site | Oslo | 0424 | Norway |
| Novartis Investigative Site | Warsaw | 04 730 | Poland |
| Novartis Investigative Site | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| Novartis Investigative Site | Stockholm | 14186 | Sweden |
| Novartis Investigative Site | Antalya | 07070 | Turkey (Türkiye) |
| Novartis Investigative Site | London | WC1N 1EH | United Kingdom |
| Novartis Investigative Site | Manchester | M13 9WL | United Kingdom |
| Novartis Investigative Site | Nottingham | NG7 2UH | United Kingdom |
| Derived |
| Tonshoff B, Tedesco-Silva H, Ettenger R, Christian M, Bjerre A, Dello Strologo L, Marks SD, Pape L, Veldandi U, Lopez P, Cousin M, Pandey P, Meier M. Three-year outcomes from the CRADLE study in de novo pediatric kidney transplant recipients receiving everolimus with reduced tacrolimus and early steroid withdrawal. Am J Transplant. 2021 Jan;21(1):123-137. doi: 10.1111/ajt.16005. Epub 2020 Jun 27. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EVR+rTAC | Investigational arm : Conversion from MMF to everolimus plus reduced dose tacrolimus and steroids withdrawal at 6 months after transplant |
| BG001 | MMF+sTAC | Control arm : MMF continuation (in combination with tacrolimus and standard dose steroids) |
| 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, Customized | Count of Participants | Participants |
| |||||||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| |||||||||||||||||||
| Race/Ethnicity, Customized | 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 | Number of Participants Having Reached the Composite Efficacy Endpoint of Biopsy-proven Acute Rejection | To estimate the rate of the composite efficacy endpoint of biopsy-proven acute rejection (BPAR), graft loss or death at 12 months post transplantation in primary paediatric kidney transplant recipients converted at 4-6 weeks post-transplantation from MMF + standard TAC regimen and steroids, to everolimus + reduced dose TAC regimen and steroid withdrawal at 6 months, versus continuation of MMF + standard TAC regimen and steroids. | Full Analysis set (12 months and 36 months) Results given as number of participants with composite efficacy failures | Posted | Count of Participants | Participants | 12 months, 36 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | To Evaluate Renal Function, Assessed by Glomerular Filtration Rate (eGFR) and Estimated by the Schwartz Formula (Abbreviated), at Month 12 and 36 | To evaluate renal function assessed by Glomerular Filtration Rate (eGFR) estimated by the Schwartz Formula (abbreviated) (Schwartz, 2009). | Full Analysis set 12 months and 36 months | Posted | Mean | Standard Error | mL/min/1.73m2 | 12 months and 36 months post-transplantation |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Composite Efficacy Endpoint | To evaluate the proportion of patients with the following efficacy events: Biopsy Proven Acute Rejection (BPAR), graft loss or death. The efficacy events will be descriptively summarized by treatment group. | full Analysis set 36 month analysis Results given as number of participants with composite efficacy failures | Posted | Count of Participants | Participants | at 12 and 36 months post-transplantation |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | To Evaluate the Severity of BPAR (Acute T-cell Mediated Rejection Only) (Banff 2009) | T-cell mediated rejection severity : Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells). Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells). Type IIA - Mild to moderate intimal arteritis Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation) | full Analysis set 36 months | Posted | Count of Participants | Participants | month 12, month 36 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | To Evaluate the Time to Event of BPAR | Time to incidence of Event, given in terms of number of participants with an Event according to time interval up to 36 months | full Analysis set, 36 month analysis | Posted | Count of Participants | Participants | 36 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Biopsy Proven Antibody Mediated Rejection. | To evaluate the proportion of patients with the following efficacy events: biopsy proven antibody mediated rejection/Steroid resistant BPAR and BPAR treated with T cell depleting therapy. | Full Analysis set | Posted | Count of Participants | Participants | at 12 and 36 months post-transplantation |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Chronic Allograft Nephropathy / Interstitial Fibrosis and Tubular Atrophy | To evaluate the proportion of patients with chronic allograft nephropathy (interstitial fibrosis and tubular atrophy, IF/TA) by histopathology and its progression.The term chronic allograft nephropathy was used inappropriately in the protocol and therefore, replaced by interstitial fibrosis and tubular atrophy | Posted | Count of Participants | Participants | at 12 and 36 months post-transplantation. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proteinuria (Urinary Protein/Creatinine Ratio) | The urinary protein/creatinine ratio will be descriptively summarized by treatment group at each visit. The incidence rate of patients with proteinuria will be categorized in <0.2 g/mg/mg, 0.2<2.0 mg/mg and ≥ 2.0 mg/mg and summarized by treatment groups at each visit. | full analysis set 36 months analysis | Posted | Count of Participants | Participants | at 12 and 36 months post-transplantation |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Growth/Development : Weight, Height, BMI : Change From Baseline | Evaluation of the potential effects upon the bone growth. The Z-score is a statistical tool which helps to assess data (here child growth parameters) relative to a reference or standard population. The Z-score describes the distance and direction of an observation away from the population median (or mean, however, here the median was used). A negative Z-score shows that data are lower than the median of the standard population, a positive Z-score shows that data are higher than the median of the standard population, and a Z-score of zero shows that the data are equal to the median of the standard population. The more the Z-score is distant from 0, the more expressed is for example underweight or overweight. | safety set, 36 months analysis | Posted | Mean | Standard Deviation | z score | month 12 , month 36 post transplantation. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Evaluation of Evolution of Renal Allograft Function Over Time | results given as eGFR values by time interval | full Analysis set 36 months | Posted | Mean | Standard Deviation | ml/min/1.73m2 | baseline, 6 months, 12 months , 24 months, 36 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | To Evaluate Renal Function, Assessed by Glomerular Filtration Rate (eGFR) and Estimated by the Schwartz Formula (Extended), at Month 12 | To evaluate renal function assessed by Glomerular Filtration Rate (eGFR) estimated by the Schwartz Formula (extended) (Schwartz, 2009). Results given as change from randomization | Full Analysis set 12 months months | Posted | Mean | Standard Deviation | mL/min/1.73m2 | 12 months post-transplantation |
|
|
up to 36 months
AE additional description
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 | EVR+rTAC | EVR+rTAC | 0 | 52 | 0 | 52 | 46 | 52 |
| EG001 | MMF+sTAC | MMF+sTAC | 0 | 54 | 0 | 54 | 48 | 54 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Epstein-Barr viraemia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Epstein-Barr virus infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.0) | 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 (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| ID | Term |
|---|---|
| D003643 | Death |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Female |
|
| Black |
|
| Asian |
|
| Other |
|
36 months |
| Log Rank |
| 0.9634 |
| Mean Difference (Final Values) |
| 0.2 |
| Standard Error of the Mean |
| 5.84 |
| 2-Sided |
| 80 |
| -7.3 |
| 7.7 |
| Non-Inferiority |
Kaplan-Meier estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula. |
|
|
|
| Participants |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|