End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement Therapy, Renal Transplantation
Conditions
Keywords
kidney failure, dialysis, renal failure, transplantation
Brief summary
This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
Interventions
BIOLOGICALInduction therapy
All subjects received induction therapy with basiliximab or rabbit anti-thymocyte globulin, in the peritransplant period.
DRUGCorticosteroids
All subjects received maintenance therapy with corticosteroids throughout the 24 month study period. A minimum dose of 5 mg prednisone, or equivalent, per day was maintained.
DRUGEVR+rCNI
Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
DRUGMPA+sCNI
Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent obtained. 2. Subject randomized within 24 hr of completion of transplant surgery. 3. Recipient of a kidney with a cold ischemia time \< 30 hours. 4. Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased heart beating, living unrelated, living related non-human leukocyte antigen identical or an expanded criteria donor.
Exclusion criteria
1. Subject unable to tolerate oral medication at time of randomization. 2. Use of other investigational drugs at the time of enrollment. 3. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. 4. Multi-organ transplant recipient. 5. Recipient of ABO incompatible allograft or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant. 6. Subject at high immunological risk for rejection as determined by local practice for assessment of anti-donor reactivity e.g. high PRA, presence of pre-existing DSA. 7. Subject who is HIV-positive. 8. HBsAg and/or a HCV positive subject with evidence of elevated LFTs (ALT/AST levels ≥ 2.5 times ULN). Viral serology results obtained within 6 months prior to randomization are acceptable. 9. Recipient of a kidney from a donor who tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV). 10. Subject with a BMI greater than 35. 11. Subject with severe systemic infections, current or within the two weeks prior to randomization. 12. Subject requiring systemic anticoagulation. 13. History of malignancy of any organ system. 14. Subject with severe restrictive or obstructive pulmonary disorders. 15. Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled. 16. Subject with white blood cell (WBC) count ≤ 2,000 /mm3 or with platelet count ≤ 50,000 /mm3. 17. Pregnant or nursing (lactating) women. 18. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2. | Month 12 is Primary, Month 24 secondary | Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) \< 50 mL/min/1.73m2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR | Baseline (week 4), Month 12 and 24 | Renal allograft function : mean estimated glomerular filtration rate, eGFR |
| Evolution of Renal Function, as eGFR, Over Time by Slope Analysis. | Month 12 and 24 | Rate of change of renal function, as eGFR, calculated using MDRD4 formula (Coresh, 2003) and adjusted by covariates. |
| Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death | Month 12 and 24 | Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death |
| Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2 | Month 12 and 24 | Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR \< 50 mL/min/1.73m2 |
| Incidence of Failure on the Composite Endpoint of Graft Loss or Death. | Month 12 and 24 | Incidence of failure on the composite endpoint of graft loss or death. |
| Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | Month 12 and 24 | Incidence of death, graft loss, tBPAR (treated biopsy proven acute rejection), BPAR (biopsy proven acute rejection), tAR (treated acute rejection), AR (acute rejection) and humoral rejection (aAMR : active antibody mediated rejection and cAMR: chronic antibody mediated rejection) |
| Renal Function Assessed by Creatinine Lab Values | Month 12 and 24 | Mean Renal function as assessed in clinical practice, by ceatinine values. Analysis is done without considering missing values for analysis. |
| Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | Month 12 and 24 | Mean Renal function as used in clinical practice, using different formula for calculation of renal function than MDRD4 (our primary efficacy parameter), and other alternate formulae (e.g. CKD-EPI). Analysis is done without considering missing values for analysis. |
| Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation. | Month 24 | Incidence of adverse events, serious adverse events and adverse events leading to study regimen discontinuation. |
| Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events. | Month 24 | Incidence of cytomegalovirus and BK virus, new onset diabetes mellitus, chronic kidney disease with associated proteinuria and calcineurin inhibitor associated adverse events. |
| Incidence of eGFR < 50 mL/Min/1.73m2 | Month 12 and 24 | Incidence of eGFR \< 50 mL/min/1.73m2 |
| Incidence of Major Cardiovascular Events. | Month 24 | Incidence of major cardiovascular events by Preferred Term |
| Incidence of Malignancies. | Month 24 | Incidence of malignancies. |
| Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2 Among Compliant Subjects. | Month 12 and 24 | Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) \< 50 mL/min/1.73m2 among compliant subjects. |
| Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants) | Month 12 and 24 | Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing 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) |
| Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events) | Month 12 and 24 | Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing 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) |
| Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections | Month 12 and 24 | Incidence of tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), excluding grade IA rejections. Grades for T-cell mediated rejection, with increasing 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) |
| Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup | Month 12 and 24 | Incidence of composite of tBPAR or eGRF\<50 mL/min/1.73m2 by subgroup |
| Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2 | Month 12 and 24 | Incidence of tBPAR (excluding grade IA rejections) or GFR\<50 mL/min/1.73m2 |
| Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death or Loss to Follow-up | Month 12 and 24 | Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death or loss to follow-up |
| Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios. | Baseline, Month 12 and 24 | Mean urinary protein and albumin excretion by treatment estimated by mean urinary protein/creatinine and urinary albumin/creatinine ratios. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, Colombia, Croatia, Czechia, Egypt, France, Germany, Greece, India, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United States
Participant flow
Recruitment details
The full analysis set consisted of all randomized and transplanted patients. The safet set consisted of all patients who received at least one dose of study drug
Pre-assignment details
2226 patients screened; 2037 patients transplanted and randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| EVR+rCNI Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus) | 1,022 |
| MPA+sCNI Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus). | 1,015 |
| Total | 2,037 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 29 | 34 |
| Overall Study | Graft Loss | 35 | 30 |
| Overall Study | Lost to Follow-up | 9 | 17 |
| Overall Study | Pregnancy | 0 | 2 |
| Overall Study | Subject / Gardian decision | 54 | 51 |
| Overall Study | technical problems | 2 | 0 |
Baseline characteristics
| Characteristic | EVR+rCNI | MPA+sCNI | Total |
|---|---|---|---|
| Age, Continuous | 48.79 years STANDARD_DEVIATION 14.123 | 48.75 years STANDARD_DEVIATION 14.515 | 48.77 years STANDARD_DEVIATION 14.316 |
| Race/Ethnicity, Customized Asian | 136 Participants | 157 Participants | 293 Participants |
| Race/Ethnicity, Customized Black | 43 Participants | 35 Participants | 78 Participants |
| Race/Ethnicity, Customized Caucasian | 743 Participants | 735 Participants | 1478 Participants |
| Race/Ethnicity, Customized Hispany or Latino | 157 Participants | 132 Participants | 289 Participants |
| Race/Ethnicity, Customized not Hispanic or Latino | 646 Participants | 661 Participants | 1307 Participants |
| Race/Ethnicity, Customized Other | 100 Participants | 88 Participants | 188 Participants |
| Race/Ethnicity, Customized Unknown or not reported | 219 Participants | 222 Participants | 441 Participants |
| Sex: Female, Male Female | 312 Participants | 308 Participants | 620 Participants |
| Sex: Female, Male Male | 710 Participants | 707 Participants | 1417 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 20 / 1,014 | 29 / 1,012 |
| other Total, other adverse events | 951 / 1,014 | 942 / 1,012 |
| serious Total, serious adverse events | 593 / 1,014 | 613 / 1,012 |
Outcome results
Primary
Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2.
Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) \< 50 mL/min/1.73m2.
Time frame: Month 12 is Primary, Month 24 secondary
Population: full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVR+rCNI | Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2. | month 12 | 489 Participants |
| EVR+rCNI | Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2. | month 24 | 489 Participants |
| MPA+sCNI | Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2. | month 12 | 456 Participants |
| MPA+sCNI | Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2. | month 24 | 443 Participants |
Comparison: calculated at month 12p-value: 0.00195% CI: [-1.4, 7.3]Logistic Regression Model
Secondary
Evolution of Renal Function, as eGFR, Over Time by Slope Analysis.
Rate of change of renal function, as eGFR, calculated using MDRD4 formula (Coresh, 2003) and adjusted by covariates.
Time frame: Month 12 and 24
Population: full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EVR+rCNI | Evolution of Renal Function, as eGFR, Over Time by Slope Analysis. | 0.0001 mL / min / 1.73m2 / day | Standard Error 0.0008 |
| MPA+sCNI | Evolution of Renal Function, as eGFR, Over Time by Slope Analysis. | 0.0047 mL / min / 1.73m2 / day | Standard Error 0.0008 |
Secondary
Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation.
Incidence of adverse events, serious adverse events and adverse events leading to study regimen discontinuation.
Time frame: Month 24
Population: safety set 24 months analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVR+rCNI | Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation. | 276 Participants |
| MPA+sCNI | Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation. | 152 Participants |
Secondary
Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup
Incidence of composite of tBPAR or eGRF\<50 mL/min/1.73m2 by subgroup
Time frame: Month 12 and 24
Population: full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVR+rCNI | Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup | month 12 | 489 Participants |
| EVR+rCNI | Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup | month 24 | 489 Participants |
| MPA+sCNI | Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup | month 12 | 456 Participants |
| MPA+sCNI | Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup | month 24 | 443 Participants |
Secondary
Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events.
Incidence of cytomegalovirus and BK virus, new onset diabetes mellitus, chronic kidney disease with associated proteinuria and calcineurin inhibitor associated adverse events.
Time frame: Month 24
Population: safety set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVR+rCNI | Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events. | clinical signs of CMV infection | 53 Participants |
| EVR+rCNI | Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events. | any BKV infection | 103 Participants |
| EVR+rCNI | Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events. | new onset of diabetes mellitus | 144 Participants |
| EVR+rCNI | Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events. | at least one event of interest | 871 Participants |
| MPA+sCNI | Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events. | at least one event of interest | 764 Participants |
| MPA+sCNI | Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events. | clinical signs of CMV infection | 132 Participants |
| MPA+sCNI | Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events. | new onset of diabetes mellitus | 138 Participants |
| MPA+sCNI | Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events. | any BKV infection | 154 Participants |
Secondary
Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection
Incidence of death, graft loss, tBPAR (treated biopsy proven acute rejection), BPAR (biopsy proven acute rejection), tAR (treated acute rejection), AR (acute rejection) and humoral rejection (aAMR : active antibody mediated rejection and cAMR: chronic antibody mediated rejection)
Time frame: Month 12 and 24
Population: full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVR+rCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | deaths month 12 | 20 Participants |
| EVR+rCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | deaths month 24 | 32 Participants |
| EVR+rCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | graft loss month 12 | 33 Participants |
| EVR+rCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | graft loss month 24 | 37 Participants |
| EVR+rCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | tBPAR month 12 | 107 Participants |
| EVR+rCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | tBPAR month 24 | 118 Participants |
| EVR+rCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | BPAR month 12 | 114 Participants |
| EVR+rCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | BPAR month 24 | 127 Participants |
| EVR+rCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | tAR month 12 | 129 Participants |
| EVR+rCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | tAR month 24 | 145 Participants |
| EVR+rCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | AR month 12 | 147 Participants |
| EVR+rCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | AR month 24 | 167 Participants |
| EVR+rCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | aAMR month 12 | 73 Participants |
| EVR+rCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | aAMR month 24 | 84 Participants |
| EVR+rCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | cAMR month 12 | 9 Participants |
| EVR+rCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | cAMR month 24 | 13 Participants |
| MPA+sCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | cAMR month 24 | 18 Participants |
| MPA+sCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | deaths month 12 | 28 Participants |
| MPA+sCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | tAR month 12 | 117 Participants |
| MPA+sCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | deaths month 24 | 36 Participants |
| MPA+sCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | aAMR month 12 | 61 Participants |
| MPA+sCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | graft loss month 12 | 28 Participants |
| MPA+sCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | tAR month 24 | 126 Participants |
| MPA+sCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | graft loss month 24 | 32 Participants |
| MPA+sCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | cAMR month 12 | 14 Participants |
| MPA+sCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | tBPAR month 12 | 91 Participants |
| MPA+sCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | AR month 12 | 133 Participants |
| MPA+sCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | tBPAR month 24 | 98 Participants |
| MPA+sCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | aAMR month 24 | 69 Participants |
| MPA+sCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | BPAR month 12 | 95 Participants |
| MPA+sCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | AR month 24 | 144 Participants |
| MPA+sCNI | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | BPAR month 24 | 104 Participants |
Secondary
Incidence of eGFR < 50 mL/Min/1.73m2
Incidence of eGFR \< 50 mL/min/1.73m2
Time frame: Month 12 and 24
Population: full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVR+rCNI | Incidence of eGFR < 50 mL/Min/1.73m2 | month 12 | 456 Participants |
| EVR+rCNI | Incidence of eGFR < 50 mL/Min/1.73m2 | month 24 | 474 Participants |
| MPA+sCNI | Incidence of eGFR < 50 mL/Min/1.73m2 | month 12 | 424 Participants |
| MPA+sCNI | Incidence of eGFR < 50 mL/Min/1.73m2 | month 24 | 423 Participants |
Secondary
Incidence of Failure on the Composite Endpoint of Graft Loss or Death.
Incidence of failure on the composite endpoint of graft loss or death.
Time frame: Month 12 and 24
Population: full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVR+rCNI | Incidence of Failure on the Composite Endpoint of Graft Loss or Death. | month 12 | 51 Participants |
| EVR+rCNI | Incidence of Failure on the Composite Endpoint of Graft Loss or Death. | month 24 | 67 Participants |
| MPA+sCNI | Incidence of Failure on the Composite Endpoint of Graft Loss or Death. | month 12 | 54 Participants |
| MPA+sCNI | Incidence of Failure on the Composite Endpoint of Graft Loss or Death. | month 24 | 65 Participants |
Secondary
Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2
Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR \< 50 mL/min/1.73m2
Time frame: Month 12 and 24
Population: full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVR+rCNI | Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2 | month 12 | 497 Participants |
| EVR+rCNI | Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2 | month 24 | 497 Participants |
| MPA+sCNI | Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2 | month 12 | 466 Participants |
| MPA+sCNI | Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2 | month 24 | 457 Participants |
Secondary
Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death
Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death
Time frame: Month 12 and 24
Population: full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVR+rCNI | Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death | month 12 | 146 Participants |
| EVR+rCNI | Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death | month 24 | 169 Participants |
| MPA+sCNI | Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death | month 12 | 131 Participants |
| MPA+sCNI | Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death | month 24 | 147 Participants |
Secondary
Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death or Loss to Follow-up
Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death or loss to follow-up
Time frame: Month 12 and 24
Population: full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVR+rCNI | Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death or Loss to Follow-up | month 12 | 181 Participants |
| EVR+rCNI | Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death or Loss to Follow-up | month 24 | 218 Participants |
| MPA+sCNI | Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death or Loss to Follow-up | month 12 | 170 Participants |
| MPA+sCNI | Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death or Loss to Follow-up | month 24 | 201 Participants |
Secondary
Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2 Among Compliant Subjects.
Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) \< 50 mL/min/1.73m2 among compliant subjects.
Time frame: Month 12 and 24
Population: compliance set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVR+rCNI | Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2 Among Compliant Subjects. | month 12 | 60 Participants |
| EVR+rCNI | Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2 Among Compliant Subjects. | month 24 | 62 Participants |
| MPA+sCNI | Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2 Among Compliant Subjects. | month 12 | 106 Participants |
| MPA+sCNI | Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2 Among Compliant Subjects. | month 24 | 102 Participants |
Secondary
Incidence of Major Cardiovascular Events.
Incidence of major cardiovascular events by Preferred Term
Time frame: Month 24
Population: safety set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVR+rCNI | Incidence of Major Cardiovascular Events. | 66 Participants |
| MPA+sCNI | Incidence of Major Cardiovascular Events. | 86 Participants |
Secondary
Incidence of Malignancies.
Incidence of malignancies.
Time frame: Month 24
Population: safety set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVR+rCNI | Incidence of Malignancies. | 41 Participants |
| MPA+sCNI | Incidence of Malignancies. | 39 Participants |
Secondary
Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2
Incidence of tBPAR (excluding grade IA rejections) or GFR\<50 mL/min/1.73m2
Time frame: Month 12 and 24
Population: full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVR+rCNI | Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2 | month 12 | 475 Participants |
| EVR+rCNI | Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2 | month 24 | 475 Participants |
| MPA+sCNI | Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2 | month 12 | 441 Participants |
| MPA+sCNI | Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2 | month 24 | 426 Participants |
Secondary
Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections
Incidence of tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), excluding grade IA rejections. Grades for T-cell mediated rejection, with increasing 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)
Time frame: Month 12 and 24
Population: full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVR+rCNI | Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections | month 12 | 66 Participants |
| EVR+rCNI | Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections | month 24 | 74 Participants |
| MPA+sCNI | Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections | month 12 | 53 Participants |
| MPA+sCNI | Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections | month 24 | 55 Participants |
Secondary
Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events)
Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing 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)
Time frame: Month 12 and 24
Population: full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EVR+rCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events) | number of tBPAR regardless of grade days 91-180 | 24 events |
| EVR+rCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events) | number of tBPAR regardless of grade days 361-540 | 12 events |
| EVR+rCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events) | number of tBPAR regardless of grade days 1-90 | 72 events |
| EVR+rCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events) | number of tBPAR regardless of grade days 541-720 | 11 events |
| EVR+rCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events) | number of tBPAR regardless of grade days 181-360 | 25 events |
| EVR+rCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events) | number of tBPAR regardless of grade days 721-810 | 2 events |
| EVR+rCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events) | overall number of tBPAR regardless of grade | 146 events |
| MPA+sCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events) | number of tBPAR regardless of grade days 721-810 | 2 events |
| MPA+sCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events) | overall number of tBPAR regardless of grade | 116 events |
| MPA+sCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events) | number of tBPAR regardless of grade days 1-90 | 63 events |
| MPA+sCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events) | number of tBPAR regardless of grade days 91-180 | 14 events |
| MPA+sCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events) | number of tBPAR regardless of grade days 181-360 | 20 events |
| MPA+sCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events) | number of tBPAR regardless of grade days 361-540 | 15 events |
| MPA+sCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events) | number of tBPAR regardless of grade days 541-720 | 2 events |
Secondary
Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants)
Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing 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)
Time frame: Month 12 and 24
Population: full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVR+rCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants) | Patient's maximum tBPAR grade : no grade (missing) | 25 Participants |
| EVR+rCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants) | Patient's maximum tBPAR grade : grade IA | 34 Participants |
| EVR+rCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants) | Patient's maximum tBPAR grade : grade IB | 23 Participants |
| EVR+rCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants) | Patient's maximum tBPAR grade : grade IIA | 21 Participants |
| EVR+rCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants) | Patient's maximum tBPAR grade : grade IIB | 9 Participants |
| EVR+rCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants) | Patient's maximum tBPAR grade : grade III | 6 Participants |
| MPA+sCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants) | Patient's maximum tBPAR grade : grade IIB | 3 Participants |
| MPA+sCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants) | Patient's maximum tBPAR grade : no grade (missing) | 18 Participants |
| MPA+sCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants) | Patient's maximum tBPAR grade : grade IIA | 24 Participants |
| MPA+sCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants) | Patient's maximum tBPAR grade : grade IA | 36 Participants |
| MPA+sCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants) | Patient's maximum tBPAR grade : grade III | 0 Participants |
| MPA+sCNI | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants) | Patient's maximum tBPAR grade : grade IB | 17 Participants |
Secondary
Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR
Renal allograft function : mean estimated glomerular filtration rate, eGFR
Time frame: Baseline (week 4), Month 12 and 24
Population: full analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVR+rCNI | Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR | month 12 | 53.29 mL/min/1.73m2 | Standard Error 0.698 |
| EVR+rCNI | Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR | baseline (week 4) | 53.13 mL/min/1.73m2 | Standard Error 0.765 |
| EVR+rCNI | Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR | month 24 | 52.63 mL/min/1.73m2 | Standard Error 0.744 |
| MPA+sCNI | Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR | baseline (week 4) | 52.25 mL/min/1.73m2 | Standard Error 0.684 |
| MPA+sCNI | Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR | month 12 | 54.49 mL/min/1.73m2 | Standard Error 0.667 |
| MPA+sCNI | Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR | month 24 | 54.91 mL/min/1.73m2 | Standard Error 0.719 |
Secondary
Renal Function Assessed by Creatinine Lab Values
Mean Renal function as assessed in clinical practice, by ceatinine values. Analysis is done without considering missing values for analysis.
Time frame: Month 12 and 24
Population: full analysis set with measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVR+rCNI | Renal Function Assessed by Creatinine Lab Values | screening baseline (creatinine, micromol/L) | 590.1 micromol/L | Standard Deviation 262.78 |
| EVR+rCNI | Renal Function Assessed by Creatinine Lab Values | month 12 (creatinine, micromol/L) | 129.8 micromol/L | Standard Deviation 49.12 |
| EVR+rCNI | Renal Function Assessed by Creatinine Lab Values | month 24 (creatinine, micromol/L) | 130.1 micromol/L | Standard Deviation 53.54 |
| MPA+sCNI | Renal Function Assessed by Creatinine Lab Values | screening baseline (creatinine, micromol/L) | 601.8 micromol/L | Standard Deviation 265.08 |
| MPA+sCNI | Renal Function Assessed by Creatinine Lab Values | month 12 (creatinine, micromol/L) | 128.6 micromol/L | Standard Deviation 50.8 |
| MPA+sCNI | Renal Function Assessed by Creatinine Lab Values | month 24 (creatinine, micromol/L) | 127.6 micromol/L | Standard Deviation 52.5 |
Secondary
Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported
Mean Renal function as used in clinical practice, using different formula for calculation of renal function than MDRD4 (our primary efficacy parameter), and other alternate formulae (e.g. CKD-EPI). Analysis is done without considering missing values for analysis.
Time frame: Month 12 and 24
Population: full analysis set with measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVR+rCNI | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | eGFR (Hoek) month 12 (mL/min/1.73m2) | 50.08 mL/min/1.73m2 | Standard Deviation 14.43 |
| EVR+rCNI | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | eGFR (MDRD4) month 24 (mL/min/1.73m2) | 58.07 mL/min/1.73m2 | Standard Deviation 20.168 |
| EVR+rCNI | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | eGFR (MDRD4) baseline (mL/min/1.73m2) | 11.79 mL/min/1.73m2 | Standard Deviation 8.697 |
| EVR+rCNI | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | eGFR-CKDEPI baseline (mL/min/1.73m2) | 11.29 mL/min/1.73m2 | Standard Deviation 9.094 |
| EVR+rCNI | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | eGFR (Hoek) month 24 (mL/min/1.73m2) | 49.86 mL/min/1.73m2 | Standard Deviation 14.604 |
| EVR+rCNI | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | eGFR-CKDEPI month 12(mL/min/1.73m2) | 58.83 mL/min/1.73m2 | Standard Deviation 20.686 |
| EVR+rCNI | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | eGFR (MDRD4) month 12 (mL/min/1.73m2) | 57.59 mL/min/1.73m2 | Standard Deviation 19.685 |
| EVR+rCNI | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | eGFR-CKDEPI month 24 (mL/min/1.73m2) | 59.39 mL/min/1.73m2 | Standard Deviation 21.077 |
| EVR+rCNI | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | eGFR (Hoek) baseline (mL/min/1.73m2) | 21.38 mL/min/1.73m2 | Standard Deviation 14.296 |
| MPA+sCNI | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | eGFR-CKDEPI month 24 (mL/min/1.73m2) | 59.95 mL/min/1.73m2 | Standard Deviation 20.652 |
| MPA+sCNI | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | eGFR (Hoek) baseline (mL/min/1.73m2) | 20.10 mL/min/1.73m2 | Standard Deviation 12.408 |
| MPA+sCNI | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | eGFR (Hoek) month 12 (mL/min/1.73m2) | 52.00 mL/min/1.73m2 | Standard Deviation 14.533 |
| MPA+sCNI | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | eGFR (Hoek) month 24 (mL/min/1.73m2) | 52.75 mL/min/1.73m2 | Standard Deviation 15.406 |
| MPA+sCNI | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | eGFR (MDRD4) baseline (mL/min/1.73m2) | 11.56 mL/min/1.73m2 | Standard Deviation 8.853 |
| MPA+sCNI | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | eGFR (MDRD4) month 12 (mL/min/1.73m2) | 57.58 mL/min/1.73m2 | Standard Deviation 18.768 |
| MPA+sCNI | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | eGFR (MDRD4) month 24 (mL/min/1.73m2) | 58.68 mL/min/1.73m2 | Standard Deviation 19.541 |
| MPA+sCNI | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | eGFR-CKDEPI baseline (mL/min/1.73m2) | 11.05 mL/min/1.73m2 | Standard Deviation 9.195 |
| MPA+sCNI | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | eGFR-CKDEPI month 12(mL/min/1.73m2) | 58.75 mL/min/1.73m2 | Standard Deviation 19.757 |
Secondary
Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios.
Mean urinary protein and albumin excretion by treatment estimated by mean urinary protein/creatinine and urinary albumin/creatinine ratios.
Time frame: Baseline, Month 12 and 24
Population: safety set with measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVR+rCNI | Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios. | protein /creatinine ratio month 12 | 298.557 mg/g | Standard Deviation 642.103 |
| EVR+rCNI | Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios. | albumine /creatinine ratio baseline | 1019.75 mg/g | Standard Deviation 2737.96 |
| EVR+rCNI | Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios. | albumine /creatinine ratio month 12 | 150.061 mg/g | Standard Deviation 482.394 |
| EVR+rCNI | Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios. | albumine /creatinine ratio month 24 | 149.049 mg/g | Standard Deviation 464.47 |
| EVR+rCNI | Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios. | protein /creatinine ratio baseline | 1648.10 mg/g | Standard Deviation 3768.22 |
| EVR+rCNI | Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios. | protein /creatinine ratio month 24 | 290.242 mg/g | Standard Deviation 588.119 |
| MPA+sCNI | Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios. | protein /creatinine ratio baseline | 1142.59 mg/g | Standard Deviation 1003.69 |
| MPA+sCNI | Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios. | protein /creatinine ratio month 12 | 234.698 mg/g | Standard Deviation 583.632 |
| MPA+sCNI | Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios. | albumine /creatinine ratio month 24 | 116.618 mg/g | Standard Deviation 433.392 |
| MPA+sCNI | Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios. | albumine /creatinine ratio baseline | 646.111 mg/g | Standard Deviation 799.234 |
| MPA+sCNI | Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios. | protein /creatinine ratio month 24 | 233.009 mg/g | Standard Deviation 524.383 |
| MPA+sCNI | Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios. | albumine /creatinine ratio month 12 | 111.322 mg/g | Standard Deviation 444.631 |