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The study has been stopped because of the lack of enrollment
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The study will evaluate kidney graft function in maintenance renal transplant patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full Dose Myfortic® and Reduced Dose Neoral® | Experimental | The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME |
|
| Standard Dose of Myfortic® and Standard Dose of CsA-ME | Active Comparator | Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteric coated mycophenolate sodium (Myfortic®) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months | The 12 month change from baseline (visit 2) in the glomerular filtration rate using the abbreviated Modification of Diet in Renal Disease (MDRD) formula to calculate GFR using the participant's serum creatinine, age, gender and ethnicity. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Creatinine Clearance at 12 Months | 12 months | |
| Serum Creatinine at 12 Months | 12 months | |
| Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months |
Not provided
Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Bologna | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Full Dose Myfortic® and Reduced Dose Neoral® | The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| 12 months |
| Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months | 12 months |
| Chronic Rejection as Confirmed by Renal Biopsy at 12 Months | 12 months |
| FG001 | Standard Dose of Myfortic® and Standard Dose of CsA-ME | Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Full Dose Myfortic® and Reduced Dose Neoral® | The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME |
| BG001 | Standard Dose of Myfortic® and Standard Dose of CsA-ME | Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months | The 12 month change from baseline (visit 2) in the glomerular filtration rate using the abbreviated Modification of Diet in Renal Disease (MDRD) formula to calculate GFR using the participant's serum creatinine, age, gender and ethnicity. | Study was terminated without analysis (small sample size). | Posted | Mean | Standard Deviation | mL/min | 12 months |
|
| |||||||||||||||||||
| Secondary | Creatinine Clearance at 12 Months | Not Posted | 12 months | ||||||||||||||||||||||||||
| Secondary | Serum Creatinine at 12 Months | Not Posted | 12 months | ||||||||||||||||||||||||||
| Secondary | Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months | Not Posted | 12 months | ||||||||||||||||||||||||||
| Secondary | Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months | Not Posted | 12 months | ||||||||||||||||||||||||||
| Secondary | Chronic Rejection as Confirmed by Renal Biopsy at 12 Months | Not Posted | 12 months |
Not provided
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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 | Full Dose Myfortic® and Reduced Dose Neoral® | The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME | 0 | 5 | 2 | 5 | ||
| EG001 | Standard Dose of Myfortic® and Standard Dose of CsA-ME | Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME. | 0 | 5 | 4 | 5 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Conjunctival irritation | Eye disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Otitis media chronic | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| Male |
|