Kidney Transplantation
Conditions
Keywords
Treatment Effectiveness, Treatment Efficacy, Anti-rejection therapy, Immunosuppression, Therapy, antirejection, Renal Transplantation, Transplantation, Kidney, Transplantation, Renal, Grafting, Kidney
Brief summary
The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.
Detailed description
A 2 arm (1 Active, 1 Active Control) study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, MMF and a rapid steroid withdrawal.
Interventions
DRUGbasiliximab
IV
DRUGtacrolimus
oral
DRUGalemtuzumab
Intravenous (IV)
DRUGmycophenolate mofetil
oral
DRUGsteroids
IV and/or oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recipient of a primary or re-transplanted deceased donor kidney or a primary or re-transplanted non-human leukocyte antigen (HLA) living donor kidney (ie., HLA identical or 0 antigen mismatch deceased donor kidneys are allowed).
Exclusion criteria
* Patient has previously received an organ transplant other than a kidney * Patient receiving chronic steroid therapy at time of transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months | 6 months | A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) & Severe (3). Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Failure | End of Study (36 months) | Efficacy Failure is a composite measure of biopsy confirmed acute rejection, graft loss and death. Data is reported as the percentage of patients with Efficacy Failure. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
| Clinically Treated Acute Rejection | End of Study (36 months) | Clinically treated acute rejection is defined as patient incidence of any rejection (suspected or otherwise) for which treatment was provided. Data is reported as the percentage of patients with Clinically Treated Acute Rejection. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
| Time to First BCAR | End of Study (36 months) | Time to first BCAR is defined as the number of days from skin closure to the first episode of BCAR. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
| Graft Survival at 12 Months | 12 months | Graft survival is defined as no graft loss (re-transplant, return to dialysis for more than 30 days or death) with 12 months of skin closure. Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first. |
| Overall Patient Incidence of BCAR | End of Study (36 months) | Overall patient incidence of BCAR is defined as a suspected new rejection at any time following skin closure confirmed by a Banff Grade ≥ 1A as assigned by a local pathologist. Incidence is reported as the percentage of patients with BCAR. The Banff 97 scale is a classification system for interpreting histology of allograft biopsies. The grades range from Mild (1A & 1B) to Moderate (2A & 2B) to Severe (3). End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
| Patient Survival at 12 Months | 12 months | Patient survival is defined as not dead within 12 months after skin closure. Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first. |
| Overall Patient Survival | End of Study (36 months) | Overall patient survival is defined as not dead at any time following skin closure. Data is reported as the percentage of patients with Overall Patient Survival. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
| Renal Function Abnormalities Based on Creatinine Clearance | 1 month and End of Study (36 months) | Increases in creatinine clearance usually indicates an improvement. Change in creatinine clearance from month 1 was calculated. Change from 1 month is calculated by month 36 - month 1. |
| Renal Function Abnormalities Based on Serum Creatinine | 1 month and End of Study (36 months) | Decrease in serum creatinine usually indicates an improvement. Change in creatinine clearance from month 1 was calculated. Change from 1 month is calculated by month 36 - month 1. |
| Overall Graft Survival | End of Study (36 months) | Overall graft survival is defined as not having graft loss (re-transplant, return to dialysis for more than 30 consecutive days, or death) at any time following skin closure. Data is reported as the percentage of patients with Overall Graft Survival. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alemtuzumab High-Risk Patients Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American | 70 |
| Conventional High-Risk Patients Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American | 69 |
| Alemtuzumab Low- Risk Patients Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American | 164 |
| Conventional Low-Risk Patients Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American | 171 |
| Total | 474 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 7 | 11 | 7 |
| Overall Study | Death in operating room | 0 | 0 | 0 | 1 |
| Overall Study | Did not meet eligibility criteria | 1 | 0 | 0 | 1 |
| Overall Study | Did not meet eligibility - pre-treatment | 0 | 0 | 0 | 2 |
| Overall Study | Discontinued due to rejection | 0 | 0 | 1 | 0 |
| Overall Study | Early graft loss, technical | 0 | 0 | 2 | 0 |
| Overall Study | Graft loss | 6 | 6 | 4 | 9 |
| Overall Study | Lost to Follow-up | 2 | 3 | 6 | 3 |
| Overall Study | Moved | 0 | 1 | 0 | 3 |
| Overall Study | Not transplanted, donor issues | 4 | 0 | 2 | 2 |
| Overall Study | Not transplanted, recipient issues | 2 | 1 | 7 | 4 |
| Overall Study | Protocol Violation | 1 | 0 | 4 | 2 |
| Overall Study | Received pancreas transplant | 0 | 0 | 0 | 2 |
| Overall Study | Sponsor elected to discontinue patient | 1 | 0 | 0 | 1 |
| Overall Study | Unable to return for follow up | 2 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 3 | 4 | 2 |
| Overall Study | Withdrew consent, Prednisone initiated | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Alemtuzumab High-Risk Patients | Conventional High-Risk Patients | Alemtuzumab Low- Risk Patients | Conventional Low-Risk Patients | Total |
|---|---|---|---|---|---|
| Age, Customized <18 years | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Customized >=65 years | 4 Participants | 5 Participants | 18 Participants | 25 Participants | 52 Participants |
| Age, Customized Between 18 and 64 years | 66 Participants | 64 Participants | 145 Participants | 146 Participants | 421 Participants |
| Panel Reactive Antibody (PRA) Group 0% | 33 Participants | 32 Participants | 134 Participants | 130 Participants | 329 Participants |
| Panel Reactive Antibody (PRA) Group > 0% - 20% | 14 Participants | 16 Participants | 24 Participants | 39 Participants | 93 Participants |
| Panel Reactive Antibody (PRA) Group > 20% - 50% | 11 Participants | 7 Participants | 2 Participants | 1 Participants | 21 Participants |
| Panel Reactive Antibody (PRA) Group > 50% | 12 Participants | 13 Participants | 3 Participants | 0 Participants | 28 Participants |
| Panel Reactive Antibody (PRA) Group Missing | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Previous Transplant No | 56 Participants | 59 Participants | 162 Participants | 168 Participants | 445 Participants |
| Previous Transplant Yes | 14 Participants | 10 Participants | 2 Participants | 3 Participants | 29 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 2 Participants | 5 Participants | 7 Participants | 16 Participants |
| Race/Ethnicity, Customized Black | 50 Participants | 47 Participants | 2 Participants | 1 Participants | 100 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 18 Participants | 20 Participants | 155 Participants | 161 Participants | 354 Participants |
| Sex: Female, Male Female | 33 Participants | 30 Participants | 49 Participants | 58 Participants | 170 Participants |
| Sex: Female, Male Male | 37 Participants | 39 Participants | 115 Participants | 113 Participants | 304 Participants |
| Type of Transplant Deceased | 42 Participants | 43 Participants | 55 Participants | 49 Participants | 189 Participants |
| Type of Transplant Living non-related | 7 Participants | 11 Participants | 45 Participants | 48 Participants | 111 Participants |
| Type of Transplant Living related | 21 Participants | 15 Participants | 64 Participants | 74 Participants | 174 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 61 / 70 | 66 / 69 | 151 / 164 | 157 / 171 |
| serious Total, serious adverse events | 33 / 70 | 40 / 69 | 91 / 164 | 81 / 171 |
Outcome results
Primary
Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months
A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) & Severe (3). Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st.
Time frame: 6 months
Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alemtuzumab High-Risk Patients | Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months | 6.2 Percentage of Patients |
| Conventional High-Risk Patients | Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months | 9.4 Percentage of Patients |
| Alemtuzumab Low- Risk Patients | Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months | 1.9 Percentage of Patients |
| Conventional Low-Risk Patients | Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months | 17.5 Percentage of Patients |
p-value: 0.488995.305% CI: [-12.7, 6.1]Normal approximation
p-value: <0.000195.305% CI: [-21.9, -9.4]normal approximation
Secondary
Clinically Treated Acute Rejection
Clinically treated acute rejection is defined as patient incidence of any rejection (suspected or otherwise) for which treatment was provided. Data is reported as the percentage of patients with Clinically Treated Acute Rejection. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
Time frame: End of Study (36 months)
Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alemtuzumab High-Risk Patients | Clinically Treated Acute Rejection | 22.9 Percentage of Patients |
| Conventional High-Risk Patients | Clinically Treated Acute Rejection | 21.7 Percentage of Patients |
| Alemtuzumab Low- Risk Patients | Clinically Treated Acute Rejection | 12.8 Percentage of Patients |
| Conventional Low-Risk Patients | Clinically Treated Acute Rejection | 26.9 Percentage of Patients |
p-value: 0.874295% CI: [-12.7, 15]normal approximation
p-value: 0.00195% CI: [-22.5, -5.7]normal approximation
Secondary
Efficacy Failure
Efficacy Failure is a composite measure of biopsy confirmed acute rejection, graft loss and death. Data is reported as the percentage of patients with Efficacy Failure. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
Time frame: End of Study (36 months)
Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alemtuzumab High-Risk Patients | Efficacy Failure | 22.9 Percentage of Patients |
| Conventional High-Risk Patients | Efficacy Failure | 29.0 Percentage of Patients |
| Alemtuzumab Low- Risk Patients | Efficacy Failure | 15.9 Percentage of Patients |
| Conventional Low-Risk Patients | Efficacy Failure | 24.6 Percentage of Patients |
p-value: 0.408795% CI: [-20.7, 8.4]normal approximation
p-value: 0.045695% CI: [-17.2, -0.2]normal approximation
Secondary
Graft Survival at 12 Months
Graft survival is defined as no graft loss (re-transplant, return to dialysis for more than 30 days or death) with 12 months of skin closure. Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first.
Time frame: 12 months
Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alemtuzumab High-Risk Patients | Graft Survival at 12 Months | 95.6 Percentage of Patients |
| Conventional High-Risk Patients | Graft Survival at 12 Months | 92.1 Percentage of Patients |
| Alemtuzumab Low- Risk Patients | Graft Survival at 12 Months | 97.5 Percentage of Patients |
| Conventional Low-Risk Patients | Graft Survival at 12 Months | 95.1 Percentage of Patients |
p-value: 0.413495% CI: [-4.8, 11.7]normal approximation
p-value: 0.245995% CI: [-1.7, 6.5]normal approximation
Secondary
Overall Graft Survival
Overall graft survival is defined as not having graft loss (re-transplant, return to dialysis for more than 30 consecutive days, or death) at any time following skin closure. Data is reported as the percentage of patients with Overall Graft Survival. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
Time frame: End of Study (36 months)
Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alemtuzumab High-Risk Patients | Overall Graft Survival | 88.6 Percentage of Patients |
| Conventional High-Risk Patients | Overall Graft Survival | 82.6 Percentage of Patients |
| Alemtuzumab Low- Risk Patients | Overall Graft Survival | 90.9 Percentage of Patients |
| Conventional Low-Risk Patients | Overall Graft Survival | 91.2 Percentage of Patients |
p-value: 0.315595% CI: [-5.7, 17.6]normal approximation
p-value: 0.904595% CI: [-6.5, 5.7]normal approximation
Secondary
Overall Patient Incidence of BCAR
Overall patient incidence of BCAR is defined as a suspected new rejection at any time following skin closure confirmed by a Banff Grade ≥ 1A as assigned by a local pathologist. Incidence is reported as the percentage of patients with BCAR. The Banff 97 scale is a classification system for interpreting histology of allograft biopsies. The grades range from Mild (1A & 1B) to Moderate (2A & 2B) to Severe (3). End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
Time frame: End of Study (36 months)
Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alemtuzumab High-Risk Patients | Overall Patient Incidence of BCAR | 15.7 Percentage of Patients |
| Conventional High-Risk Patients | Overall Patient Incidence of BCAR | 13.0 Percentage of Patients |
| Alemtuzumab Low- Risk Patients | Overall Patient Incidence of BCAR | 9.8 Percentage of Patients |
| Conventional Low-Risk Patients | Overall Patient Incidence of BCAR | 21.6 Percentage of Patients |
p-value: 0.653395% CI: [-9, 14.3]normal approximation
p-value: 0.002495% CI: [-19.5, -4.2]normal approximation
Secondary
Overall Patient Survival
Overall patient survival is defined as not dead at any time following skin closure. Data is reported as the percentage of patients with Overall Patient Survival. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
Time frame: End of Study (36 months)
Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alemtuzumab High-Risk Patients | Overall Patient Survival | 95.7 Percentage of Patients |
| Conventional High-Risk Patients | Overall Patient Survival | 89.9 Percentage of Patients |
| Alemtuzumab Low- Risk Patients | Overall Patient Survival | 93.9 Percentage of Patients |
| Conventional Low-Risk Patients | Overall Patient Survival | 95.3 Percentage of Patients |
p-value: 0.179795% CI: [-2.7, 14.4]normal approximation
p-value: 0.565595% CI: [-6.3, 3.4]normal approximation
Secondary
Patient Survival at 12 Months
Patient survival is defined as not dead within 12 months after skin closure. Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first.
Time frame: 12 months
Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alemtuzumab High-Risk Patients | Patient Survival at 12 Months | 98.6 Percentage of Patients |
| Conventional High-Risk Patients | Patient Survival at 12 Months | 96.9 Percentage of Patients |
| Alemtuzumab Low- Risk Patients | Patient Survival at 12 Months | 98.1 Percentage of Patients |
| Conventional Low-Risk Patients | Patient Survival at 12 Months | 98.7 Percentage of Patients |
p-value: 0.526595% CI: [-3.4, 6.7]normal approximation
p-value: 0.68295% CI: [-3.4, 2.2]normal approximation
Secondary
Renal Function Abnormalities Based on Creatinine Clearance
Increases in creatinine clearance usually indicates an improvement. Change in creatinine clearance from month 1 was calculated. Change from 1 month is calculated by month 36 - month 1.
Time frame: 1 month and End of Study (36 months)
Population: The number of participants analyzed represents Full Analysis Set: all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. Only patients with the test result at a given time point were included in each time point analysis, and these numbers are noted in the category titles as N.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alemtuzumab High-Risk Patients | Renal Function Abnormalities Based on Creatinine Clearance | Month 1 (N= 65; 65; 162; 161) | 0.882 mL/s | Standard Deviation 0.3585 |
| Alemtuzumab High-Risk Patients | Renal Function Abnormalities Based on Creatinine Clearance | Change from Month 1 (N= 48; 46; 125; 129) | 0.031 mL/s | Standard Deviation 0.3599 |
| Alemtuzumab High-Risk Patients | Renal Function Abnormalities Based on Creatinine Clearance | Month 36 (N= 48; 47; 125; 131) | 0.976 mL/s | Standard Deviation 0.3772 |
| Conventional High-Risk Patients | Renal Function Abnormalities Based on Creatinine Clearance | Month 1 (N= 65; 65; 162; 161) | 0.833 mL/s | Standard Deviation 0.2515 |
| Conventional High-Risk Patients | Renal Function Abnormalities Based on Creatinine Clearance | Change from Month 1 (N= 48; 46; 125; 129) | 0.039 mL/s | Standard Deviation 0.2649 |
| Conventional High-Risk Patients | Renal Function Abnormalities Based on Creatinine Clearance | Month 36 (N= 48; 47; 125; 131) | 0.862 mL/s | Standard Deviation 0.2929 |
| Alemtuzumab Low- Risk Patients | Renal Function Abnormalities Based on Creatinine Clearance | Month 36 (N= 48; 47; 125; 131) | 1.011 mL/s | Standard Deviation 0.2736 |
| Alemtuzumab Low- Risk Patients | Renal Function Abnormalities Based on Creatinine Clearance | Month 1 (N= 65; 65; 162; 161) | 0.906 mL/s | Standard Deviation 0.272 |
| Alemtuzumab Low- Risk Patients | Renal Function Abnormalities Based on Creatinine Clearance | Change from Month 1 (N= 48; 46; 125; 129) | 0.080 mL/s | Standard Deviation 0.2592 |
| Conventional Low-Risk Patients | Renal Function Abnormalities Based on Creatinine Clearance | Month 1 (N= 65; 65; 162; 161) | 0.891 mL/s | Standard Deviation 0.2668 |
| Conventional Low-Risk Patients | Renal Function Abnormalities Based on Creatinine Clearance | Change from Month 1 (N= 48; 46; 125; 129) | 0.140 mL/s | Standard Deviation 0.2698 |
| Conventional Low-Risk Patients | Renal Function Abnormalities Based on Creatinine Clearance | Month 36 (N= 48; 47; 125; 131) | 1.039 mL/s | Standard Deviation 0.3195 |
Comparison: P-Value applies to 'Change from Month 1'p-value: 0.4735ANCOVA
Comparison: P-Value applies to 'Change from Month 1'p-value: 0.1186ANCOVA
Secondary
Renal Function Abnormalities Based on Serum Creatinine
Decrease in serum creatinine usually indicates an improvement. Change in creatinine clearance from month 1 was calculated. Change from 1 month is calculated by month 36 - month 1.
Time frame: 1 month and End of Study (36 months)
Population: The number of participants analyzed represents Full Analysis Set: all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. Only patients with the test result at a given time point were included in each time point analysis, and these numbers are noted in the category titles as N.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alemtuzumab High-Risk Patients | Renal Function Abnormalities Based on Serum Creatinine | Month 36 (N= 49; 47; 126; 131) | 136.6 mcmol/L | Standard Deviation 68.38 |
| Alemtuzumab High-Risk Patients | Renal Function Abnormalities Based on Serum Creatinine | Month 1 (N= 67; 65; 163; 162) | 151.7 mcmol/L | Standard Deviation 88.12 |
| Alemtuzumab High-Risk Patients | Renal Function Abnormalities Based on Serum Creatinine | Change from Month 1 (N= 49; 46; 126; 129) | 1.8 mcmol/L | Standard Deviation 69.41 |
| Conventional High-Risk Patients | Renal Function Abnormalities Based on Serum Creatinine | Month 36 (N= 49; 47; 126; 131) | 152.0 mcmol/L | Standard Deviation 84.85 |
| Conventional High-Risk Patients | Renal Function Abnormalities Based on Serum Creatinine | Change from Month 1 (N= 49; 46; 126; 129) | 3.4 mcmol/L | Standard Deviation 92.8 |
| Conventional High-Risk Patients | Renal Function Abnormalities Based on Serum Creatinine | Month 1 (N= 67; 65; 163; 162) | 155.9 mcmol/L | Standard Deviation 97.18 |
| Alemtuzumab Low- Risk Patients | Renal Function Abnormalities Based on Serum Creatinine | Month 36 (N= 49; 47; 126; 131) | 121.7 mcmol/L | Standard Deviation 40.09 |
| Alemtuzumab Low- Risk Patients | Renal Function Abnormalities Based on Serum Creatinine | Change from Month 1 (N= 49; 46; 126; 129) | -8.0 mcmol/L | Standard Deviation 44.07 |
| Alemtuzumab Low- Risk Patients | Renal Function Abnormalities Based on Serum Creatinine | Month 1 (N= 67; 65; 163; 162) | 139.0 mcmol/L | Standard Deviation 56.82 |
| Conventional Low-Risk Patients | Renal Function Abnormalities Based on Serum Creatinine | Change from Month 1 (N= 49; 46; 126; 129) | -18.7 mcmol/L | Standard Deviation 42.35 |
| Conventional Low-Risk Patients | Renal Function Abnormalities Based on Serum Creatinine | Month 1 (N= 67; 65; 163; 162) | 138.2 mcmol/L | Standard Deviation 46.03 |
| Conventional Low-Risk Patients | Renal Function Abnormalities Based on Serum Creatinine | Month 36 (N= 49; 47; 126; 131) | 117.1 mcmol/L | Standard Deviation 35.5 |
Comparison: P-Value applies to 'Change from Month 1'p-value: 0.5231ANCOVA
Comparison: P-Value applies to 'Change from Month 1'p-value: 0.122ANCOVA
Secondary
Time to First BCAR
Time to first BCAR is defined as the number of days from skin closure to the first episode of BCAR. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.
Time frame: End of Study (36 months)
Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.~Only patients who experienced BCAR were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alemtuzumab High-Risk Patients | Time to First BCAR | 226 Days |
| Conventional High-Risk Patients | Time to First BCAR | 49 Days |
| Alemtuzumab Low- Risk Patients | Time to First BCAR | 469 Days |
| Conventional Low-Risk Patients | Time to First BCAR | 13 Days |