Graft Rejection
Conditions
Keywords
Everolimus, heart transplant, heart disease, transplantation, heart IVUS assessment at 12 months, rate of graft loss, acute rejection episodes, survival
Brief summary
This trial was to examine the impact of everolimus and reduced dose of cyclosporine on efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in heart transplant recipients.
Interventions
DRUGeverolimus
Everolimus supplied as 0.75 mg tablets. Everolimus was also supplied in 0.25 mg and 0.5 mg tablets for dose adjustments.
DRUGmycophenolate mofetil
Mycophenolate mofetil supplied as 500 mg tablets.
DRUGcyclosporine
Cyclosporine reduced dose in the everolimus arms (approximately half of the standard dose) and standard dose in the mycophenolate mofetil arm.
DRUGcorticosteroids
Corticosteroids standard dose.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male or female cardiac recipients 18-70 years of age undergoing primary heart transplantation. * The graft must be functional at time of randomization.
Exclusion criteria
* Patients who are recipients of multiple solid organ transplants or tissue transplants or have previously received organ transplants. * Patients who are recipients of ABO incompatible transplants. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Composite Efficacy Failure at 12 Months | 12 Months | Composite efficacy failure was defined as Biopsy Proven Acute Rejection(BPAR) of International Society for Heart and Lung Transplantation(ISHLT) grade ≥3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up. Identification of acute rejection was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤30% or 25% lower than Baseline or Fractional shortening ≤20% or 25% lower than Baseline and/or use of inotropic treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal Function Measured by Glomerular Filtration Rate (GFR) at 12 Months | 12 Months | GFR was calculated using the Modification of Diet and Renal Disease (MDRD) formula: GFR \[mL/min/1.73m\^2\] = 186.3\*(C\^-1.154)\*(A\^-0.203)\*G\*R where C is the serum concentration of creatinine \[mg/dL\] A is age \[years\] G=0.742 when gender is female, otherwise G=1 R=1.21 when race is black, otherwise R=1 |
| Change From Baseline in the Average Maximum Intimal Thickness at Month 12 | Baseline, Month 12 | Maximum intimal thickness was assessed using Intravascular Ultrasound (IVUS). IVUS is a technique for taking ultrasound pictures of the wall of an artery from inside the artery itself. It shows the thickness of the artery wall and any narrowing of the artery. |
| Percentage of Participants With Cardiac Allograft Vasculopathy (CAV) at Month 12 | 12 Months | Cardiac allograft vasculopathy is defined as a 0.5 mm increase in maximum intimal thickness as measured by Intravascular Ultrasound (IVUS) in at least one matched slice between baseline and Month 12. |
| Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12 | 12 Months | Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline, and/or use of inotropic treatment. |
| Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months | 12 Months | Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 316 (start day of the Month 12 visit window). |
| Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 24 Months | 24 Months | Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 631 (start day of 24 Month visit window). |
| Renal Function Calculated by Glomerular Filtration Rate (GFR) at 24 Months | 24 Months | GFR was calculated using the Modification of Diet and Renal Disease (MDRD) formula: GFR \[mL/min/1.73m\^2\] = 186.3\*(C\^-1.154)\*(A\^-0.203)\*G\*R C is the serum concentration of creatinine \[mg/dL\] A is age \[years\] G=0.742 when gender is female, otherwise G=1 R=1.21 when race is black, otherwise R=1 |
| Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24 | 24 Months | Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline, and/ or use of inotropic treatment. |
| Percentage of Participants With Composite Efficacy Failure at 24 Months | 24 Months | Composite efficacy failure was defined as Biopsy Proven Acute Rejection (BPAR) of International Society for Heart and Lung Transplantation grade ≥ 3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up. Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline and/or use of inotropic treatment. |
Countries
Argentina, Australia, Austria, Belgium, Canada, France, Germany, Italy, New Zealand, Norway, Puerto Rico, Spain, Taiwan, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Everolimus 1.5 mg Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL. | 282 |
| Everolimus 3.0 mg Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL. | 168 |
| Mycophenolate Mofetil Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months. | 271 |
| Total | 721 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 31 | 20 | 25 |
| Overall Study | Lost to Follow-up | 3 | 4 | 5 |
| Overall Study | Re-transplant | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 12 | 3 | 14 |
Baseline characteristics
| Characteristic | Everolimus 1.5 mg | Everolimus 3.0 mg | Mycophenolate Mofetil | Total |
|---|---|---|---|---|
| Age Continuous | 51.1 years STANDARD_DEVIATION 10.99 | 48.9 years STANDARD_DEVIATION 12.06 | 50.2 years STANDARD_DEVIATION 11.88 | 50.3 years STANDARD_DEVIATION 11.6 |
| Sex: Female, Male Female | 57 Participants | 39 Participants | 51 Participants | 147 Participants |
| Sex: Female, Male Male | 225 Participants | 129 Participants | 220 Participants | 574 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 275 / 279 | 165 / 167 | 262 / 268 |
| serious Total, serious adverse events | 209 / 279 | 119 / 167 | 168 / 268 |
Outcome results
Primary
Percentage of Participants With Composite Efficacy Failure at 12 Months
Composite efficacy failure was defined as Biopsy Proven Acute Rejection(BPAR) of International Society for Heart and Lung Transplantation(ISHLT) grade ≥3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up. Identification of acute rejection was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤30% or 25% lower than Baseline or Fractional shortening ≤20% or 25% lower than Baseline and/or use of inotropic treatment.
Time frame: 12 Months
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Everolimus 1.5 mg | Percentage of Participants With Composite Efficacy Failure at 12 Months | 35.1 Percentage of participants |
| Everolimus 3.0 mg | Percentage of Participants With Composite Efficacy Failure at 12 Months | 35.1 Percentage of participants |
| Mycophenolate Mofetil | Percentage of Participants With Composite Efficacy Failure at 12 Months | 33.6 Percentage of participants |
Secondary
Change From Baseline in the Average Maximum Intimal Thickness at Month 12
Maximum intimal thickness was assessed using Intravascular Ultrasound (IVUS). IVUS is a technique for taking ultrasound pictures of the wall of an artery from inside the artery itself. It shows the thickness of the artery wall and any narrowing of the artery.
Time frame: Baseline, Month 12
Population: IVUS population consisted of randomized patients who had a minimum of 11 matched slices between IVUS images from Baseline and from Month 12 (IVUS Centers).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Everolimus 1.5 mg | Change From Baseline in the Average Maximum Intimal Thickness at Month 12 | 0.03 mm | Standard Deviation 0.052 |
| Everolimus 3.0 mg | Change From Baseline in the Average Maximum Intimal Thickness at Month 12 | 0.04 mm | Standard Deviation 0.06 |
| Mycophenolate Mofetil | Change From Baseline in the Average Maximum Intimal Thickness at Month 12 | 0.07 mm | Standard Deviation 0.11 |
Secondary
Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24
Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline, and/ or use of inotropic treatment.
Time frame: 24 Months
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Everolimus 1.5 mg | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24 | AR associated with HDC | 4.3 Percentage of participants |
| Everolimus 1.5 mg | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24 | Graft loss/re-transplant | 2.5 Percentage of participants |
| Everolimus 1.5 mg | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24 | Death | 10.6 Percentage of participants |
| Everolimus 1.5 mg | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24 | BPAR of ISHLT grade ≥ 3A | 24.1 Percentage of participants |
| Everolimus 3.0 mg | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24 | Death | 11.9 Percentage of participants |
| Everolimus 3.0 mg | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24 | BPAR of ISHLT grade ≥ 3A | 28.6 Percentage of participants |
| Everolimus 3.0 mg | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24 | Graft loss/re-transplant | 3.0 Percentage of participants |
| Everolimus 3.0 mg | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24 | AR associated with HDC | 3.6 Percentage of participants |
| Mycophenolate Mofetil | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24 | Graft loss/re-transplant | 3.7 Percentage of participants |
| Mycophenolate Mofetil | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24 | AR associated with HDC | 5.2 Percentage of participants |
| Mycophenolate Mofetil | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24 | BPAR of ISHLT grade ≥ 3A | 27.3 Percentage of participants |
| Mycophenolate Mofetil | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24 | Death | 9.2 Percentage of participants |
Secondary
Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12
Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline, and/or use of inotropic treatment.
Time frame: 12 Months
Population: Intent-to-treat population includes all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Everolimus 1.5 mg | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12 | AR associated with HDC | 3.9 Percentage of participants |
| Everolimus 1.5 mg | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12 | BPAR of ISHLT ≥ 3A | 22.3 Percentage of participants |
| Everolimus 1.5 mg | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12 | Death | 7.8 Percentage of participants |
| Everolimus 1.5 mg | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12 | Graft loss/re-transplant | 1.4 Percentage of participants |
| Everolimus 3.0 mg | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12 | Graft loss/re-transplant | 3.0 Percentage of participants |
| Everolimus 3.0 mg | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12 | AR associated with HDC | 3.0 Percentage of participants |
| Everolimus 3.0 mg | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12 | Death | 10.1 Percentage of participants |
| Everolimus 3.0 mg | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12 | BPAR of ISHLT ≥ 3A | 25.6 Percentage of participants |
| Mycophenolate Mofetil | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12 | Graft loss/re-transplant | 1.8 Percentage of participants |
| Mycophenolate Mofetil | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12 | BPAR of ISHLT ≥ 3A | 24.7 Percentage of participants |
| Mycophenolate Mofetil | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12 | Death | 4.8 Percentage of participants |
| Mycophenolate Mofetil | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12 | AR associated with HDC | 2.6 Percentage of participants |
Secondary
Percentage of Participants With Cardiac Allograft Vasculopathy (CAV) at Month 12
Cardiac allograft vasculopathy is defined as a 0.5 mm increase in maximum intimal thickness as measured by Intravascular Ultrasound (IVUS) in at least one matched slice between baseline and Month 12.
Time frame: 12 Months
Population: IVUS population consisted of randomized patients who had a minimum of 11 matched slices between IVUS images from Baseline and from Month 12 (IVUS centers).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Everolimus 1.5 mg | Percentage of Participants With Cardiac Allograft Vasculopathy (CAV) at Month 12 | 12.5 Percentage of participants |
| Everolimus 3.0 mg | Percentage of Participants With Cardiac Allograft Vasculopathy (CAV) at Month 12 | 21.6 Percentage of participants |
| Mycophenolate Mofetil | Percentage of Participants With Cardiac Allograft Vasculopathy (CAV) at Month 12 | 26.7 Percentage of participants |
Secondary
Percentage of Participants With Composite Efficacy Failure at 24 Months
Composite efficacy failure was defined as Biopsy Proven Acute Rejection (BPAR) of International Society for Heart and Lung Transplantation grade ≥ 3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up. Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline and/or use of inotropic treatment.
Time frame: 24 Months
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Everolimus 1.5 mg | Percentage of Participants With Composite Efficacy Failure at 24 Months | 39.4 Percentage of participants |
| Everolimus 3.0 mg | Percentage of Participants With Composite Efficacy Failure at 24 Months | 41.1 Percentage of participants |
| Mycophenolate Mofetil | Percentage of Participants With Composite Efficacy Failure at 24 Months | 41.3 Percentage of participants |
Secondary
Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months
Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 316 (start day of the Month 12 visit window).
Time frame: 12 Months
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Everolimus 1.5 mg | Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months | 11.7 Percentage of participants |
| Everolimus 3.0 mg | Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months | 11.9 Percentage of participants |
| Mycophenolate Mofetil | Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months | 8.9 Percentage of participants |
Secondary
Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 24 Months
Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 631 (start day of 24 Month visit window).
Time frame: 24 Months
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Everolimus 1.5 mg | Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 24 Months | 15.2 Percentage of participants |
| Everolimus 3.0 mg | Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 24 Months | 16.1 Percentage of participants |
| Mycophenolate Mofetil | Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 24 Months | 15.1 Percentage of participants |
Secondary
Renal Function Calculated by Glomerular Filtration Rate (GFR) at 24 Months
GFR was calculated using the Modification of Diet and Renal Disease (MDRD) formula: GFR \[mL/min/1.73m\^2\] = 186.3\*(C\^-1.154)\*(A\^-0.203)\*G\*R C is the serum concentration of creatinine \[mg/dL\] A is age \[years\] G=0.742 when gender is female, otherwise G=1 R=1.21 when race is black, otherwise R=1
Time frame: 24 Months
Population: Participants from the intent-to-treat population (all randomized participants) with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Everolimus 1.5 mg | Renal Function Calculated by Glomerular Filtration Rate (GFR) at 24 Months | 59.50 mL/min/1.73^2 | Standard Deviation 22.438 |
| Everolimus 3.0 mg | Renal Function Calculated by Glomerular Filtration Rate (GFR) at 24 Months | 61.84 mL/min/1.73^2 | Standard Deviation 25.247 |
| Mycophenolate Mofetil | Renal Function Calculated by Glomerular Filtration Rate (GFR) at 24 Months | 64.52 mL/min/1.73^2 | Standard Deviation 23.764 |
Secondary
Renal Function Measured by Glomerular Filtration Rate (GFR) at 12 Months
GFR was calculated using the Modification of Diet and Renal Disease (MDRD) formula: GFR \[mL/min/1.73m\^2\] = 186.3\*(C\^-1.154)\*(A\^-0.203)\*G\*R where C is the serum concentration of creatinine \[mg/dL\] A is age \[years\] G=0.742 when gender is female, otherwise G=1 R=1.21 when race is black, otherwise R=1
Time frame: 12 Months
Population: Participants from the intent-to-treat population (all randomized participants) with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Everolimus 1.5 mg | Renal Function Measured by Glomerular Filtration Rate (GFR) at 12 Months | 59.21 mL/min/1.73^2 | Standard Deviation 23.113 |
| Everolimus 3.0 mg | Renal Function Measured by Glomerular Filtration Rate (GFR) at 12 Months | 59.78 mL/min/1.73^2 | Standard Deviation 23.141 |
| Mycophenolate Mofetil | Renal Function Measured by Glomerular Filtration Rate (GFR) at 12 Months | 64.37 mL/min/1.73^2 | Standard Deviation 28.365 |