Renal Transplantation
Conditions
Keywords
Everolimus, calcineurine inhibitor, renal transplantation in maintenance, chronic allograft nephropathy
Brief summary
Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in study CRAD001A2420 (NCT00154297) until the end (12 months) and having not prematurely discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine microemulsion + steroids).
Interventions
DRUGEverolimus + Cyclosporine
DRUGEverolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)
DRUGSteroids
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Patients who participated in and completed study CRAD001A2420
Exclusion criteria
* Premature study or study treatment discontinuation in CRAD001A2420 study. * Acute rejection within the 3 months prior to inclusion Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients. | From Baseline to Month 12 | Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12) |
| Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial | From Baseline to Month 12 | Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12. | Month 12 | — |
| Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12 | From Baseline to Month 3, 6, and 12 | Change in creatinine clearance, Nankivell formula (mL/min/1.73m²) from baseline to M12 |
| Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12 | From Baseline to Month 3, 6, and 12 | Change in proteinuria (g/24h) from baseline to M12 |
| Assessing Cardiovascular Risk Factors Based on Fasting Glucose. | From Baseline to Month 1, 3, 6, 9, and 12 | Blood chemistry - fasting glycemia (mmol/L) |
| Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12 | From Baseline to Month 3, 6, and 12 | — |
| Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. | From Baseline to Month 3, 6, and 12 | — |
| Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides. | From Baseline to Month 1, 3, 6, 9, and 12 | — |
| Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP). | From Baseline to Month 3, 6, and 12 | Blood chemistry - C-reactive Protein (CRP) (mg/L) |
| Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. | From Baseline to Month 1, 3, 6, 9, and 12 | Blood chemistry - total cholesterol (mmol/L) |
| Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12. | Month 6 and 12 | — |
Countries
France
Participant flow
Recruitment details
This is a prospective, national, multicenter, randomized, open label study, 12 months duration. Ten centers have been included with a study start October 2006 and end date May 2009.
Participants by arm
| Arm | Count |
|---|---|
| Cyclosporine Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids | 15 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Cyclosporine | Enteric-coated Mycophenolate Sodium (EC-MPS) | Total |
|---|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 9.46 | 58.8 years STANDARD_DEVIATION 7.55 | 60.6 years STANDARD_DEVIATION 8.6 |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 15 | 14 / 15 |
| serious Total, serious adverse events | 8 / 15 | 10 / 15 |
Outcome results
Primary
Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients.
Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)
Time frame: From Baseline to Month 12
Population: Intent to Treat (ITT) Population: all patients with a baseline value
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cyclosporine | Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients. | -4.07 (mL/min) | Standard Error 5.03 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients. | 10.30 (mL/min) | Standard Error 4.84 |
Primary
Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial
Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)
Time frame: From Baseline to Month 12
Population: Intent to Treat (ITT) Population: completed patients
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cyclosporine | Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial | 1.46 (mL/min) | Standard Error 6.6 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial | 12.00 (mL/min) | Standard Error 5.06 |
Secondary
Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP).
Blood chemistry - C-reactive Protein (CRP) (mg/L)
Time frame: From Baseline to Month 3, 6, and 12
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP). | Baseline [N = 13; N = 14] | 11.4 mg/L | Standard Deviation 17.83 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP). | Month 3 [N = 11; N = 11] | 6.3 mg/L | Standard Deviation 4.88 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP). | Month 6 [N = 11; N = 9] | 8.0 mg/L | Standard Deviation 8.24 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP). | Month 12 [N = 14; N = 12] | 34.2 mg/L | Standard Deviation 62.92 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP). | Month 12 [N = 14; N = 12] | 12.6 mg/L | Standard Deviation 27.23 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP). | Baseline [N = 13; N = 14] | 3.0 mg/L | Standard Deviation 2.45 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP). | Month 6 [N = 11; N = 9] | 5.6 mg/L | Standard Deviation 5.75 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP). | Month 3 [N = 11; N = 11] | 10.3 mg/L | Standard Deviation 16.27 |
Secondary
Assessing Cardiovascular Risk Factors Based on Fasting Glucose.
Blood chemistry - fasting glycemia (mmol/L)
Time frame: From Baseline to Month 1, 3, 6, 9, and 12
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting Glucose. | Baseline [N = 15; N = 15] | 5.5 mmol/L | Standard Deviation 0.97 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting Glucose. | Month 1 [N = 15; N = 15] | 5.2 mmol/L | Standard Deviation 0.9 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting Glucose. | Month 3 [N = 14; N = 15] | 5.6 mmol/L | Standard Deviation 1.26 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting Glucose. | Month 6 [N = 14; N = 14] | 5.5 mmol/L | Standard Deviation 1.15 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting Glucose. | Month 9 [N = 12; N = 13] | 5.3 mmol/L | Standard Deviation 1.04 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting Glucose. | Month 12 [N = 14; N = 13] | 4.8 mmol/L | Standard Deviation 0.94 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting Glucose. | Month 9 [N = 12; N = 13] | 5.6 mmol/L | Standard Deviation 1.6 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting Glucose. | Baseline [N = 15; N = 15] | 5.2 mmol/L | Standard Deviation 0.47 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting Glucose. | Month 6 [N = 14; N = 14] | 5.1 mmol/L | Standard Deviation 1.06 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting Glucose. | Month 1 [N = 15; N = 15] | 5.3 mmol/L | Standard Deviation 0.95 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting Glucose. | Month 12 [N = 14; N = 13] | 5.4 mmol/L | Standard Deviation 1.21 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting Glucose. | Month 3 [N = 14; N = 15] | 5.2 mmol/L | Standard Deviation 1.26 |
Secondary
Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol.
Time frame: From Baseline to Month 3, 6, and 12
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. | Baseline LDL [N = 10; N = 14] | 3.4 mmol/L | Standard Deviation 0.89 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. | Baseline HDL [N = 10; N = 14] | 1.5 mmol/L | Standard Deviation 0.54 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. | Month 3 LDL [N = 12; N = 14] | 3.2 mmol/L | Standard Deviation 0.89 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. | Month 3 HDL [N = 12; N = 13] | 1.7 mmol/L | Standard Deviation 0.75 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. | Month 6 LDL [N = 12; N = 12] | 3.2 mmol/L | Standard Deviation 1.15 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. | Month 6 HDL [N = 12; N = 12] | 1.6 mmol/L | Standard Deviation 0.47 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. | Month 12 LDL [N = 10; N = 11] | 3.0 mmol/L | Standard Deviation 0.84 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. | Month 12 HDL [N = 10; N = 11] | 1.7 mmol/L | Standard Deviation 0.74 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. | Month 12 HDL [N = 10; N = 11] | 1.5 mmol/L | Standard Deviation 0.52 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. | Baseline LDL [N = 10; N = 14] | 3.1 mmol/L | Standard Deviation 0.84 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. | Month 6 LDL [N = 12; N = 12] | 3.3 mmol/L | Standard Deviation 1.48 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. | Baseline HDL [N = 10; N = 14] | 1.5 mmol/L | Standard Deviation 0.51 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. | Month 12 LDL [N = 10; N = 11] | 3.2 mmol/L | Standard Deviation 0.65 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. | Month 3 LDL [N = 12; N = 14] | 3.4 mmol/L | Standard Deviation 0.97 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. | Month 6 HDL [N = 12; N = 12] | 1.4 mmol/L | Standard Deviation 0.5 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. | Month 3 HDL [N = 12; N = 13] | 1.5 mmol/L | Standard Deviation 0.37 |
Secondary
Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol.
Blood chemistry - total cholesterol (mmol/L)
Time frame: From Baseline to Month 1, 3, 6, 9, and 12
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. | Baseline [N = 13; N = 14] | 5.7 mmol/L | Standard Deviation 1.42 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. | Month 1 [N = 11; N = 14] | 5.0 mmol/L | Standard Deviation 1.2 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. | Month 3 [N = 13; N = 14] | 5.3 mmol/L | Standard Deviation 1.77 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. | Month 6 [N = 12; N = 12] | 5.5 mmol/L | Standard Deviation 1.6 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. | Month 9 [N = 9; N = 12] | 5.4 mmol/L | Standard Deviation 1.49 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. | Month 12 [N = 12; N = 11] | 5.6 mmol/L | Standard Deviation 1.61 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. | Month 9 [N = 9; N = 12] | 5.4 mmol/L | Standard Deviation 1.31 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. | Baseline [N = 13; N = 14] | 6.0 mmol/L | Standard Deviation 2.26 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. | Month 6 [N = 12; N = 12] | 5.7 mmol/L | Standard Deviation 1.78 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. | Month 1 [N = 11; N = 14] | 5.7 mmol/L | Standard Deviation 0.76 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. | Month 12 [N = 12; N = 11] | 5.8 mmol/L | Standard Deviation 0.6 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. | Month 3 [N = 13; N = 14] | 5.6 mmol/L | Standard Deviation 1.43 |
Secondary
Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides.
Time frame: From Baseline to Month 1, 3, 6, 9, and 12
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides. | Month 3 [N = 13; N = 14] | 2.0 mmol/L | Standard Deviation 0.78 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides. | Month 9 [N = 10; N = 12] | 1.9 mmol/L | Standard Deviation 0.77 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides. | Month 1 [N = 10; N = 14] | 2.1 mmol/L | Standard Deviation 1.16 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides. | Month 12 [N = 12; N = 11] | 2.3 mmol/L | Standard Deviation 1.05 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides. | Month 6 [N = 12; N = 12] | 1.9 mmol/L | Standard Deviation 0.51 |
| Cyclosporine | Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides. | Baseline [N = 11; N = 14] | 2.4 mmol/L | Standard Deviation 1.43 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides. | Month 6 [N = 12; N = 12] | 2.1 mmol/L | Standard Deviation 0.68 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides. | Month 1 [N = 10; N = 14] | 2.0 mmol/L | Standard Deviation 0.81 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides. | Month 3 [N = 13; N = 14] | 2.2 mmol/L | Standard Deviation 0.78 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides. | Baseline [N = 11; N = 14] | 1.8 mmol/L | Standard Deviation 0.93 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides. | Month 9 [N = 10; N = 12] | 2.2 mmol/L | Standard Deviation 0.94 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides. | Month 12 [N = 12; N = 11] | 2.3 mmol/L | Standard Deviation 0.95 |
Secondary
Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12
Change in creatinine clearance, Nankivell formula (mL/min/1.73m²) from baseline to M12
Time frame: From Baseline to Month 3, 6, and 12
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12 | Baseline [N = 12; N = 13] | 56.3 mL/min/1.73m² | Standard Deviation 20.07 |
| Cyclosporine | Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12 | Month 3 [N = 10; N = 14] | 57.3 mL/min/1.73m² | Standard Deviation 19.49 |
| Cyclosporine | Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12 | Month 6 [N = 10; N = 12] | 50.3 mL/min/1.73m² | Standard Deviation 15.98 |
| Cyclosporine | Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12 | Month 12 [N = 7; N = 11] | 48.7 mL/min/1.73m² | Standard Deviation 24.7 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12 | Month 12 [N = 7; N = 11] | 70.1 mL/min/1.73m² | Standard Deviation 18.34 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12 | Baseline [N = 12; N = 13] | 60.3 mL/min/1.73m² | Standard Deviation 18.49 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12 | Month 6 [N = 10; N = 12] | 68.1 mL/min/1.73m² | Standard Deviation 18.25 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12 | Month 3 [N = 10; N = 14] | 67.1 mL/min/1.73m² | Standard Deviation 19.24 |
Secondary
Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12
Change in proteinuria (g/24h) from baseline to M12
Time frame: From Baseline to Month 3, 6, and 12
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12 | Baseline [N = 9; N = 10] | 0.44 g/24h | Standard Deviation 0.447 |
| Cyclosporine | Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12 | Month 3 [N = 9; N = 8] | 0.53 g/24h | Standard Deviation 0.248 |
| Cyclosporine | Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12 | Month 6 [N = 6; N = 5] | 0.44 g/24h | Standard Deviation 0.335 |
| Cyclosporine | Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12 | Month 12 [N = 7; N = 10] | 0.48 g/24h | Standard Deviation 0.537 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12 | Month 12 [N = 7; N = 10] | 0.75 g/24h | Standard Deviation 0.732 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12 | Baseline [N = 9; N = 10] | 0.47 g/24h | Standard Deviation 0.39 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12 | Month 6 [N = 6; N = 5] | 0.33 g/24h | Standard Deviation 0.262 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12 | Month 3 [N = 9; N = 8] | 0.24 g/24h | Standard Deviation 0.267 |
Secondary
Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12
Time frame: From Baseline to Month 3, 6, and 12
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12 | Baseline [N = 13; N = 14] | 161.7 µmol/L | Standard Deviation 60.78 |
| Cyclosporine | Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12 | Month 3 [N = 12; N = 14] | 156.6 µmol/L | Standard Deviation 51.41 |
| Cyclosporine | Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12 | Month 6 [N = 12; N = 13] | 170.8 µmol/L | Standard Deviation 59.36 |
| Cyclosporine | Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12 | Month 12 [N = 13; N = 14] | 227.7 µmol/L | Standard Deviation 144 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12 | Month 12 [N = 13; N = 14] | 130.4 µmol/L | Standard Deviation 40.27 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12 | Baseline [N = 13; N = 14] | 153.2 µmol/L | Standard Deviation 47.46 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12 | Month 6 [N = 12; N = 13] | 139.8 µmol/L | Standard Deviation 42.81 |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12 | Month 3 [N = 12; N = 14] | 138.9 µmol/L | Standard Deviation 40.85 |
Secondary
Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12.
Time frame: Month 6 and 12
Population: Intent to Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12. | Yes: treatment failure Month 6 | 0 participants |
| Cyclosporine | Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12. | No: treatment failure Month 6 | 0 participants |
| Cyclosporine | Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12. | Yes: treatment failure Month 12 | 1 participants |
| Cyclosporine | Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12. | No: treatment failure Month 12 | 12 participants |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12. | No: treatment failure Month 12 | 14 participants |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12. | Yes: treatment failure Month 6 | 0 participants |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12. | Yes: treatment failure Month 12 | 0 participants |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12. | No: treatment failure Month 6 | 0 participants |
Secondary
Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12.
Time frame: Month 12
Population: Intent to Treat (ITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12. | BPAR 12 months | 1 participants |
| Cyclosporine | Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12. | Graft Loss 12 months | 0 participants |
| Cyclosporine | Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12. | Death 12 months | 1 participants |
| Cyclosporine | Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12. | Lost to Follow-up 12 months | 0 participants |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12. | Lost to Follow-up 12 months | 0 participants |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12. | BPAR 12 months | 0 participants |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12. | Death 12 months | 0 participants |
| Enteric-coated Mycophenolate Sodium (EC-MPS) | Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12. | Graft Loss 12 months | 0 participants |