Kidney Transplantation
Conditions
Keywords
kidney transplant, alefacept
Brief summary
A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.
Detailed description
This is a 4 arm (all active) study to determine the safety and efficacy of Alefacept in de novo kidney transplant recipients.
Interventions
DRUGAlefacept
Administered as a 7.5 mg intravenous bolus on day 0 (intraoperatively, prior to kidney revascularization) and Day 3; subsequently administered subcutaneously either weekly or every 2 weeks.
DRUGtacrolimus
The initial dose of tacrolimus was administered orally within 48 hours post-transplant. Subsequent doses were to be adjusted to achieve target whole blood trough concentrations.
DRUGbasiliximab
Administered as a 20 mg bolus injection within 2 hours prior to transplantation and a 20 mg bolus injection on Day 3.
DRUGmycophenolate mofetil
Administered at 750 mg twice per day orally or intravenously for patients enrolled under Amendment 6 or earlier and at 1000 mg twice per day orally or intravenously for patients enrolled under Amendment 7. The dose of MMF could be adjusted based on clinical symptoms.
DRUGCorticosteroids
Corticosteroids were administered as a 500 to 1000 mg intravenous bolus on Day 0 and a 125 to 250 mg methylprednisone (or equivalent oral/intravenous corticosteroid dose) on Day 1. Oral prednisone was to be tapered per protocol.
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
* Subject is anticipated to receive first oral dose of tacrolimus within 48 hours of transplant procedure * Subject is a recipient of a de novo kidney transplant * Subject is a recipient of a kidney from a non-human leukocyte antigen (HLA) identical related living donor, a non-related living donor, or a deceased donor
Exclusion criteria
* Subject has a screening (pre-operative)estimated cluster of differentiation (CD) 4+ T-cell count of \< 250 cells/µL * Subject will receive a kidney with an anticipated cold ischemia time (CIT) of \> 30 hours * Recipient has a positive T or B-cell cross match by investigational site's standard method of determination * Subject will receive a kidney from a 50-65 year old deceased donor with one of the following: * History of hypertension and a terminal serum creatinine \> 1.5 mg/dL * Cerebrovascular accident as cause of death and a terminal serum creatinine \> 1.5 mg/dL * History of hypertension and cerebrovascular accident as cause of death and a terminal serum creatinine \> 1.5 mg/dL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review | 6 months | Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Day 182 was used for the analyses at 6 months. Lost to follow-up or patients with missing outcomes were censored at their last follow up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft Survival at Month 6 and Month 12 | 6 months and 12 months | Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months and 12 months after the skin closure date. Graft loss was defined as patient death, retransplant, permanent return to dialysis (dialysis greater than 30 days) or transplant nephrectomy. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. |
| Percentage of Participants With BCAR at Month 12 Assessed by Local Review | 12 months | Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Day 365 was used for the analyses at 12 months. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. |
| Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review | 6 months and 12 months | Rejection episodes were confirmed by biopsy by a central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. |
| Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review | 6 months and 12 months | Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. |
| Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review | 6 months and 12 months | Rejection episodes were confirmed by biopsy by the central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. |
| Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12 | Week 4, Month 6 and Month 12 | The glomerular filtration rate (GFR) was calculated using the Modification of Diet in Renal Disease (MDRD) method. |
| Change From Week 4 in GFR by Iothalamate Clearance at Month 6 | Week 4 and Month 6 | The glomerular filtration rate was measured directly using iothalamate clearance. |
| Change From Week 4 in Serum Creatinine at Month 6 and 12 | Week 4 and Month 6 and 12 | — |
| Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review | 6 months and 12 months | Efficacy failure is defined as death, graft failure (permanent return to dialysis \[\>30 days\] or retransplant), BCAR according to local review, or lost to follow-up. |
| Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review | 6 months and 12 months | Efficacy failure is defined as death, graft failure (permanent return to dialysis \[\>30 days\] or retransplant), BCAR according to central review, or lost to follow-up. |
| Time to First BCAR Assessed by Local Review | 12 months | The time to first BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis. |
| Patient Survival at Month 6 and Month 12 | 6 months and 12 months | Patient survival is any participant who is known to be alive 6 months and 12 months after the skin closure date. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. |
| Time to First T-cell Mediated BCAR Assessed by Local Review | 12 months | The time to first T-cell mediated BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1. |
| Time to First T-cell Mediated BCAR Assessed by Central Review | 12 months | The time to first T-cell mediated BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a T-cell mediated BCAR are included in the analysis. |
| Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | 6 months and 12 months | The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis. Grade IA: Cases with significant interstitial infiltration (\> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (\> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising \>25% of the luminal area; Grade III: Cases with transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. |
| Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | 6 months and 12 months | The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis. Grade IA: Cases with significant interstitial infiltration (\> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (\> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising \>25% of the luminal area; Grade III: Cases with transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. |
| Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12 | 6 months and 12 months | Patients who received immunosuppressive medications for the treatment of suspected or BCAR were considered to have a clinically-treated acute rejection. |
| Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12 | 6 months and 12 months | Participants with histologically proved Banff Grade II or III rejection could receive anti-rejection therapy with anti-lymphocyte antibodies per institutional protocol. The use of anti-lymphocyte antibody therapy at any time during a suspected or proven rejection episode for the treatment of acute rejection was considered an event. |
| Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12 | 6 months and 12 months | All participants were evaluated for the incidence of multiple rejection episodes (clinically treated and/or BCAR as assessed by the local reviewer) through 6 months and 12 months. |
| Percentage of Participants With Treatment Failure at Month 6 and 12 | 6 months and 12 months | Treatment failure was defined as death, graft loss, BCAR (local review), lost to follow-up or early discontinuation of treatment regimen. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. |
| Gastrointestinal Quality of Life Index Score Over Time | Months 1, 3, 6, and 12 | The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Quality of Life Index (GIQLI) symptom severity score. The GIQLI is a 36-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past 2 weeks on a scale from 0 (all of the time) to 4 (never). Possible overall scores ranged from 0 to 4, with higher scores indicating a better quality of life according to the different symptomatic criteria. |
| Gastrointestinal Symptom Rating Scale Scores Over Time | Months 1, 3, 6, and 12 | The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Symptom Rating Scale Scores (GSRS). The GSRS a 15-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to gastrointestinal symptoms. |
| Time to First BCAR Assessed by Central Review | 12 months | The time to first BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis. |
Countries
United States
Participant flow
Recruitment details
This study enrolled de novo kidney transplant recipients who were at least 18 years of age.
Participants by arm
| Arm | Count |
|---|---|
| Tacrolimus/MMF/Basiliximab Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months. | 79 |
| Alefacept QW/Tacrolimus/MMF Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months. | 77 |
| Alefacept QW/Tacrolimus Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. | 75 |
| Alefacept QOW/Tacrolimus/MMF Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. | 78 |
| Total | 309 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 2 | 2 | 3 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 1 |
| Overall Study | Miscellaneous Reasons | 7 | 3 | 11 | 4 |
| Overall Study | Randomized but never received study drug | 3 | 3 | 5 | 3 |
Baseline characteristics
| Characteristic | Tacrolimus/MMF/Basiliximab | Alefacept QW/Tacrolimus/MMF | Alefacept QW/Tacrolimus | Alefacept QOW/Tacrolimus/MMF | Total |
|---|---|---|---|---|---|
| Age, Continuous | 48.44 years STANDARD_DEVIATION 15.077 | 49.26 years STANDARD_DEVIATION 13.532 | 47.80 years STANDARD_DEVIATION 12.469 | 49.68 years STANDARD_DEVIATION 13.749 | 48.80 years STANDARD_DEVIATION 13.707 |
| Sex: Female, Male Female | 28 Participants | 20 Participants | 27 Participants | 24 Participants | 99 Participants |
| Sex: Female, Male Male | 51 Participants | 57 Participants | 48 Participants | 54 Participants | 210 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 | 79 / 79 | 77 / 77 | 75 / 75 | 78 / 78 |
| serious Total, serious adverse events | 41 / 79 | 48 / 77 | 40 / 75 | 45 / 78 |
Outcome results
Primary
Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Day 182 was used for the analyses at 6 months. Lost to follow-up or patients with missing outcomes were censored at their last follow up visit.
Time frame: 6 months
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review | 12.7 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review | 26.3 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review | 18.8 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review | 16.7 percentage of participants |
90% CI: [3.2, 23.9]
90% CI: [-3.6, 15.8]
90% CI: [-5.3, 13.3]
Secondary
Change From Week 4 in GFR by Iothalamate Clearance at Month 6
The glomerular filtration rate was measured directly using iothalamate clearance.
Time frame: Week 4 and Month 6
Population: Full analysis set with available data at Week 4. N indicates participants with available data at Week 4 and Month 6.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Change From Week 4 in GFR by Iothalamate Clearance at Month 6 | Change at Month 6 (N=48, 45, 45, 47) | 5.81 mL/min per 1.73 m^2 | Standard Deviation 24.298 |
| Tacrolimus/MMF/Basiliximab | Change From Week 4 in GFR by Iothalamate Clearance at Month 6 | Week 4 | 48.00 mL/min per 1.73 m^2 | Standard Deviation 26.327 |
| Alefacept QW/Tacrolimus/MMF | Change From Week 4 in GFR by Iothalamate Clearance at Month 6 | Week 4 | 56.51 mL/min per 1.73 m^2 | Standard Deviation 33.612 |
| Alefacept QW/Tacrolimus/MMF | Change From Week 4 in GFR by Iothalamate Clearance at Month 6 | Change at Month 6 (N=48, 45, 45, 47) | 3.47 mL/min per 1.73 m^2 | Standard Deviation 34.708 |
| Alefacept QW/Tacrolimus | Change From Week 4 in GFR by Iothalamate Clearance at Month 6 | Change at Month 6 (N=48, 45, 45, 47) | 3.56 mL/min per 1.73 m^2 | Standard Deviation 21.104 |
| Alefacept QW/Tacrolimus | Change From Week 4 in GFR by Iothalamate Clearance at Month 6 | Week 4 | 44.36 mL/min per 1.73 m^2 | Standard Deviation 19.045 |
| Alefacept QOW/Tacrolimus/MMF | Change From Week 4 in GFR by Iothalamate Clearance at Month 6 | Change at Month 6 (N=48, 45, 45, 47) | 6.60 mL/min per 1.73 m^2 | Standard Deviation 35.09 |
| Alefacept QOW/Tacrolimus/MMF | Change From Week 4 in GFR by Iothalamate Clearance at Month 6 | Week 4 | 52.09 mL/min per 1.73 m^2 | Standard Deviation 25.696 |
Secondary
Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12
The glomerular filtration rate (GFR) was calculated using the Modification of Diet in Renal Disease (MDRD) method.
Time frame: Week 4, Month 6 and Month 12
Population: Full analysis set with available data at Week 4. N indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12 | Week 4 | 54.7 mL/min per 1.73 m^2 | Standard Deviation 17.16 |
| Tacrolimus/MMF/Basiliximab | Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12 | Change at Month 12 (n=66, 64, 64, 66) | 8.9 mL/min per 1.73 m^2 | Standard Deviation 18.88 |
| Tacrolimus/MMF/Basiliximab | Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12 | Change at Month 6 (N=65, 66, 67, 66) | 5.7 mL/min per 1.73 m^2 | Standard Deviation 16.44 |
| Alefacept QW/Tacrolimus/MMF | Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12 | Change at Month 12 (n=66, 64, 64, 66) | 3.3 mL/min per 1.73 m^2 | Standard Deviation 16.55 |
| Alefacept QW/Tacrolimus/MMF | Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12 | Week 4 | 59.3 mL/min per 1.73 m^2 | Standard Deviation 24.01 |
| Alefacept QW/Tacrolimus/MMF | Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12 | Change at Month 6 (N=65, 66, 67, 66) | 3.2 mL/min per 1.73 m^2 | Standard Deviation 13.86 |
| Alefacept QW/Tacrolimus | Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12 | Change at Month 6 (N=65, 66, 67, 66) | 8.3 mL/min per 1.73 m^2 | Standard Deviation 12.96 |
| Alefacept QW/Tacrolimus | Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12 | Week 4 | 51.6 mL/min per 1.73 m^2 | Standard Deviation 19.32 |
| Alefacept QW/Tacrolimus | Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12 | Change at Month 12 (n=66, 64, 64, 66) | 9.1 mL/min per 1.73 m^2 | Standard Deviation 13.59 |
| Alefacept QOW/Tacrolimus/MMF | Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12 | Week 4 | 58.0 mL/min per 1.73 m^2 | Standard Deviation 16.97 |
| Alefacept QOW/Tacrolimus/MMF | Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12 | Change at Month 12 (n=66, 64, 64, 66) | 2.7 mL/min per 1.73 m^2 | Standard Deviation 16.6 |
| Alefacept QOW/Tacrolimus/MMF | Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12 | Change at Month 6 (N=65, 66, 67, 66) | 2.5 mL/min per 1.73 m^2 | Standard Deviation 12.82 |
Secondary
Change From Week 4 in Serum Creatinine at Month 6 and 12
Time frame: Week 4 and Month 6 and 12
Population: Full analysis set with available data at Week 4. N indicates participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Change From Week 4 in Serum Creatinine at Month 6 and 12 | Week 4 | 1.5 mg/dL | Standard Deviation 0.68 |
| Tacrolimus/MMF/Basiliximab | Change From Week 4 in Serum Creatinine at Month 6 and 12 | Change at Month 12 (N=67, 67, 65, 68) | -0.1 mg/dL | Standard Deviation 0.45 |
| Tacrolimus/MMF/Basiliximab | Change From Week 4 in Serum Creatinine at Month 6 and 12 | Change at Month 6 (N=69, 69, 68, 70) | -0.0 mg/dL | Standard Deviation 0.64 |
| Alefacept QW/Tacrolimus/MMF | Change From Week 4 in Serum Creatinine at Month 6 and 12 | Week 4 | 1.6 mg/dL | Standard Deviation 1.25 |
| Alefacept QW/Tacrolimus/MMF | Change From Week 4 in Serum Creatinine at Month 6 and 12 | Change at Month 12 (N=67, 67, 65, 68) | -0.2 mg/dL | Standard Deviation 1.24 |
| Alefacept QW/Tacrolimus/MMF | Change From Week 4 in Serum Creatinine at Month 6 and 12 | Change at Month 6 (N=69, 69, 68, 70) | -0.2 mg/dL | Standard Deviation 1.08 |
| Alefacept QW/Tacrolimus | Change From Week 4 in Serum Creatinine at Month 6 and 12 | Change at Month 6 (N=69, 69, 68, 70) | -0.3 mg/dL | Standard Deviation 0.64 |
| Alefacept QW/Tacrolimus | Change From Week 4 in Serum Creatinine at Month 6 and 12 | Week 4 | 1.6 mg/dL | Standard Deviation 0.84 |
| Alefacept QW/Tacrolimus | Change From Week 4 in Serum Creatinine at Month 6 and 12 | Change at Month 12 (N=67, 67, 65, 68) | -0.2 mg/dL | Standard Deviation 0.76 |
| Alefacept QOW/Tacrolimus/MMF | Change From Week 4 in Serum Creatinine at Month 6 and 12 | Week 4 | 1.5 mg/dL | Standard Deviation 0.73 |
| Alefacept QOW/Tacrolimus/MMF | Change From Week 4 in Serum Creatinine at Month 6 and 12 | Change at Month 12 (N=67, 67, 65, 68) | 0.1 mg/dL | Standard Deviation 0.64 |
| Alefacept QOW/Tacrolimus/MMF | Change From Week 4 in Serum Creatinine at Month 6 and 12 | Change at Month 6 (N=69, 69, 68, 70) | -0.0 mg/dL | Standard Deviation 0.32 |
Secondary
Gastrointestinal Quality of Life Index Score Over Time
The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Quality of Life Index (GIQLI) symptom severity score. The GIQLI is a 36-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past 2 weeks on a scale from 0 (all of the time) to 4 (never). Possible overall scores ranged from 0 to 4, with higher scores indicating a better quality of life according to the different symptomatic criteria.
Time frame: Months 1, 3, 6, and 12
Population: Full analysis set with available data at each time point (indicated by N)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Gastrointestinal Quality of Life Index Score Over Time | Month 1 (N=63, 60, 59, 58) | 2.85 units on a scale | Standard Deviation 0.602 |
| Tacrolimus/MMF/Basiliximab | Gastrointestinal Quality of Life Index Score Over Time | Month 3 (N=53, 52, 53, 54) | 2.96 units on a scale | Standard Deviation 0.595 |
| Tacrolimus/MMF/Basiliximab | Gastrointestinal Quality of Life Index Score Over Time | Month 6 (N=58, 61, 57, 59) | 3.05 units on a scale | Standard Deviation 0.589 |
| Tacrolimus/MMF/Basiliximab | Gastrointestinal Quality of Life Index Score Over Time | Month 12 (N=62, 60, 52, 58) | 3.13 units on a scale | Standard Deviation 0.524 |
| Alefacept QW/Tacrolimus/MMF | Gastrointestinal Quality of Life Index Score Over Time | Month 3 (N=53, 52, 53, 54) | 3.29 units on a scale | Standard Deviation 0.441 |
| Alefacept QW/Tacrolimus/MMF | Gastrointestinal Quality of Life Index Score Over Time | Month 6 (N=58, 61, 57, 59) | 3.26 units on a scale | Standard Deviation 0.45 |
| Alefacept QW/Tacrolimus/MMF | Gastrointestinal Quality of Life Index Score Over Time | Month 12 (N=62, 60, 52, 58) | 3.18 units on a scale | Standard Deviation 0.554 |
| Alefacept QW/Tacrolimus/MMF | Gastrointestinal Quality of Life Index Score Over Time | Month 1 (N=63, 60, 59, 58) | 2.97 units on a scale | Standard Deviation 0.541 |
| Alefacept QW/Tacrolimus | Gastrointestinal Quality of Life Index Score Over Time | Month 6 (N=58, 61, 57, 59) | 3.24 units on a scale | Standard Deviation 0.491 |
| Alefacept QW/Tacrolimus | Gastrointestinal Quality of Life Index Score Over Time | Month 3 (N=53, 52, 53, 54) | 3.11 units on a scale | Standard Deviation 0.516 |
| Alefacept QW/Tacrolimus | Gastrointestinal Quality of Life Index Score Over Time | Month 12 (N=62, 60, 52, 58) | 3.26 units on a scale | Standard Deviation 0.605 |
| Alefacept QW/Tacrolimus | Gastrointestinal Quality of Life Index Score Over Time | Month 1 (N=63, 60, 59, 58) | 3.00 units on a scale | Standard Deviation 0.513 |
| Alefacept QOW/Tacrolimus/MMF | Gastrointestinal Quality of Life Index Score Over Time | Month 12 (N=62, 60, 52, 58) | 3.19 units on a scale | Standard Deviation 0.531 |
| Alefacept QOW/Tacrolimus/MMF | Gastrointestinal Quality of Life Index Score Over Time | Month 3 (N=53, 52, 53, 54) | 3.16 units on a scale | Standard Deviation 0.442 |
| Alefacept QOW/Tacrolimus/MMF | Gastrointestinal Quality of Life Index Score Over Time | Month 1 (N=63, 60, 59, 58) | 2.98 units on a scale | Standard Deviation 0.493 |
| Alefacept QOW/Tacrolimus/MMF | Gastrointestinal Quality of Life Index Score Over Time | Month 6 (N=58, 61, 57, 59) | 3.17 units on a scale | Standard Deviation 0.456 |
Secondary
Gastrointestinal Symptom Rating Scale Scores Over Time
The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Symptom Rating Scale Scores (GSRS). The GSRS a 15-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to gastrointestinal symptoms.
Time frame: Months 1, 3, 6, and 12
Population: Full analysis set with available data at each time point (indicated by N)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Gastrointestinal Symptom Rating Scale Scores Over Time | Month 1 (N=70, 61, 61, 64) | 1.72 units on a scale | Standard Deviation 0.665 |
| Tacrolimus/MMF/Basiliximab | Gastrointestinal Symptom Rating Scale Scores Over Time | Month 12 (N=63, 65, 53, 65) | 1.63 units on a scale | Standard Deviation 0.635 |
| Tacrolimus/MMF/Basiliximab | Gastrointestinal Symptom Rating Scale Scores Over Time | Month 6 (N=63, 67, 62, 63) | 1.63 units on a scale | Standard Deviation 0.602 |
| Tacrolimus/MMF/Basiliximab | Gastrointestinal Symptom Rating Scale Scores Over Time | Month 3 (N=58, 55, 53, 56) | 1.52 units on a scale | Standard Deviation 0.48 |
| Alefacept QW/Tacrolimus/MMF | Gastrointestinal Symptom Rating Scale Scores Over Time | Month 1 (N=70, 61, 61, 64) | 1.43 units on a scale | Standard Deviation 0.49 |
| Alefacept QW/Tacrolimus/MMF | Gastrointestinal Symptom Rating Scale Scores Over Time | Month 12 (N=63, 65, 53, 65) | 1.42 units on a scale | Standard Deviation 0.564 |
| Alefacept QW/Tacrolimus/MMF | Gastrointestinal Symptom Rating Scale Scores Over Time | Month 3 (N=58, 55, 53, 56) | 1.42 units on a scale | Standard Deviation 0.672 |
| Alefacept QW/Tacrolimus/MMF | Gastrointestinal Symptom Rating Scale Scores Over Time | Month 6 (N=63, 67, 62, 63) | 1.41 units on a scale | Standard Deviation 0.695 |
| Alefacept QW/Tacrolimus | Gastrointestinal Symptom Rating Scale Scores Over Time | Month 1 (N=70, 61, 61, 64) | 1.59 units on a scale | Standard Deviation 0.674 |
| Alefacept QW/Tacrolimus | Gastrointestinal Symptom Rating Scale Scores Over Time | Month 12 (N=63, 65, 53, 65) | 1.52 units on a scale | Standard Deviation 0.609 |
| Alefacept QW/Tacrolimus | Gastrointestinal Symptom Rating Scale Scores Over Time | Month 6 (N=63, 67, 62, 63) | 1.49 units on a scale | Standard Deviation 0.471 |
| Alefacept QW/Tacrolimus | Gastrointestinal Symptom Rating Scale Scores Over Time | Month 3 (N=58, 55, 53, 56) | 1.47 units on a scale | Standard Deviation 0.568 |
| Alefacept QOW/Tacrolimus/MMF | Gastrointestinal Symptom Rating Scale Scores Over Time | Month 12 (N=63, 65, 53, 65) | 1.57 units on a scale | Standard Deviation 0.642 |
| Alefacept QOW/Tacrolimus/MMF | Gastrointestinal Symptom Rating Scale Scores Over Time | Month 1 (N=70, 61, 61, 64) | 1.48 units on a scale | Standard Deviation 0.491 |
| Alefacept QOW/Tacrolimus/MMF | Gastrointestinal Symptom Rating Scale Scores Over Time | Month 3 (N=58, 55, 53, 56) | 1.34 units on a scale | Standard Deviation 0.37 |
| Alefacept QOW/Tacrolimus/MMF | Gastrointestinal Symptom Rating Scale Scores Over Time | Month 6 (N=63, 67, 62, 63) | 1.42 units on a scale | Standard Deviation 0.496 |
Secondary
Graft Survival at Month 6 and Month 12
Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months and 12 months after the skin closure date. Graft loss was defined as patient death, retransplant, permanent return to dialysis (dialysis greater than 30 days) or transplant nephrectomy. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Time frame: 6 months and 12 months
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Graft Survival at Month 6 and Month 12 | Month 6 | 96.2 percentage of participants |
| Tacrolimus/MMF/Basiliximab | Graft Survival at Month 6 and Month 12 | Month 12 | 87.3 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Graft Survival at Month 6 and Month 12 | Month 12 | 90.9 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Graft Survival at Month 6 and Month 12 | Month 6 | 93.5 percentage of participants |
| Alefacept QW/Tacrolimus | Graft Survival at Month 6 and Month 12 | Month 12 | 86.5 percentage of participants |
| Alefacept QW/Tacrolimus | Graft Survival at Month 6 and Month 12 | Month 6 | 96.0 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Graft Survival at Month 6 and Month 12 | Month 12 | 85.8 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Graft Survival at Month 6 and Month 12 | Month 6 | 92.3 percentage of participants |
Comparison: Graft survival at 6 months90% CI: [-8.5, 3.1]
Comparison: Graft survival at 6 months90% CI: [-5.3, 4.9]
Comparison: Graft survival at 6 months90% CI: [-10, 2.2]
Comparison: Graft survival at 12 months90% CI: [-4.6, 11.7]
Comparison: Graft survival at 12 months90% CI: [-9.9, 8.1]
Comparison: Graft survival at 12 months90% CI: [-10.6, 7.4]
Secondary
Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review
The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis. Grade IA: Cases with significant interstitial infiltration (\> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (\> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising \>25% of the luminal area; Grade III: Cases with transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.
Time frame: 6 months and 12 months
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade IA | 1 participants |
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade III | 0 participants |
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade IIB | 0 participants |
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade III | 0 participants |
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade IIB | 0 participants |
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade IB | 0 participants |
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade IA | 1 participants |
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade IIA | 5 participants |
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade IB | 0 participants |
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade IIA | 5 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade IIA | 6 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade IA | 1 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade IB | 3 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade IIB | 2 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade III | 1 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade IA | 1 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade IB | 4 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade IIA | 6 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade IIB | 2 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade III | 1 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade IIA | 3 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade IA | 2 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade IA | 2 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade IB | 1 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade IB | 1 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade IIA | 3 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade III | 0 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade IIB | 3 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade IIB | 3 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade III | 0 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade IIB | 4 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade IIB | 4 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade IIA | 5 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade IA | 1 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade IB | 1 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade IA | 1 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade IIA | 5 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 6 - Grade III | 0 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade IB | 2 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | Month 12 - Grade III | 0 participants |
Secondary
Maximum Grade of T-cell Mediated Rejection Assessed by Local Review
The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis. Grade IA: Cases with significant interstitial infiltration (\> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (\> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising \>25% of the luminal area; Grade III: Cases with transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.
Time frame: 6 months and 12 months
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade IIA | 3 participants |
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade IA | 4 participants |
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade IB | 3 participants |
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade IIB | 0 participants |
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade III | 0 participants |
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade IIA | 3 participants |
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade IIB | 0 participants |
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade IA | 5 participants |
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade III | 0 participants |
| Tacrolimus/MMF/Basiliximab | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade IB | 3 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade III | 0 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade IIA | 10 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade IA | 6 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade IB | 4 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade IB | 5 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade IA | 6 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade IIA | 9 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade IIB | 0 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade IIB | 0 participants |
| Alefacept QW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade III | 0 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade III | 0 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade IA | 8 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade IB | 3 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade IIA | 3 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade IIB | 0 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade III | 0 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade IA | 8 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade IB | 3 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade IIA | 3 participants |
| Alefacept QW/Tacrolimus | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade IIB | 0 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade III | 0 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade IA | 2 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade IIA | 3 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade IIB | 4 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade IIA | 3 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade III | 0 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade IIB | 4 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 6 - Grade IB | 4 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade IB | 4 participants |
| Alefacept QOW/Tacrolimus/MMF | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | Month 12 - Grade IA | 3 participants |
Secondary
Patient Survival at Month 6 and Month 12
Patient survival is any participant who is known to be alive 6 months and 12 months after the skin closure date. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Time frame: 6 months and 12 months
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Patient Survival at Month 6 and Month 12 | Month 6 | 96.2 percentage of participants |
| Tacrolimus/MMF/Basiliximab | Patient Survival at Month 6 and Month 12 | Month 12 | 87.3 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Patient Survival at Month 6 and Month 12 | Month 12 | 92.2 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Patient Survival at Month 6 and Month 12 | Month 6 | 94.8 percentage of participants |
| Alefacept QW/Tacrolimus | Patient Survival at Month 6 and Month 12 | Month 6 | 97.3 percentage of participants |
| Alefacept QW/Tacrolimus | Patient Survival at Month 6 and Month 12 | Month 12 | 87.8 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Patient Survival at Month 6 and Month 12 | Month 6 | 93.6 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Patient Survival at Month 6 and Month 12 | Month 12 | 89.7 percentage of participants |
Comparison: Patient survival at 6 months90% CI: [-6.9, 4.1]
Comparison: Patient survival at 6 months90% CI: [-3.5, 5.8]
Comparison: Patient survival at 6 months90% CI: [-8.4, 3.2]
Comparison: Patient survival at 12 months90% CI: [-3.1, 12.8]
Comparison: Patient survival at 12 months90% CI: [-8.3, 9.2]
Comparison: Patient survival at 12 months90% CI: [-6, 10.8]
Secondary
Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12
Participants with histologically proved Banff Grade II or III rejection could receive anti-rejection therapy with anti-lymphocyte antibodies per institutional protocol. The use of anti-lymphocyte antibody therapy at any time during a suspected or proven rejection episode for the treatment of acute rejection was considered an event.
Time frame: 6 months and 12 months
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12 | Month 6 | 6.3 percentage of participants |
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12 | Month 12 | 6.3 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12 | Month 12 | 20.8 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12 | Month 6 | 20.8 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12 | Month 6 | 12.0 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12 | Month 12 | 12.0 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12 | Month 6 | 7.7 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12 | Month 12 | 7.7 percentage of participants |
Secondary
Percentage of Participants With BCAR at Month 12 Assessed by Local Review
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Day 365 was used for the analyses at 12 months. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Time frame: 12 months
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With BCAR at Month 12 Assessed by Local Review | 15.4 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With BCAR at Month 12 Assessed by Local Review | 29.0 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With BCAR at Month 12 Assessed by Local Review | 20.2 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With BCAR at Month 12 Assessed by Local Review | 18.1 percentage of participants |
90% CI: [2.8, 24.6]
90% CI: [-5.4, 15]
90% CI: [-7.1, 12.6]
Secondary
Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review
Rejection episodes were confirmed by biopsy by a central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Time frame: 6 months and 12 months
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review | Month 6 | 7.7 percentage of participants |
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review | Month 12 | 7.7 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review | Month 12 | 19.7 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review | Month 6 | 18.3 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review | Month 6 | 12.1 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review | Month 12 | 12.1 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review | Month 6 | 14.2 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review | Month 12 | 15.5 percentage of participants |
Comparison: BCAR at Month 690% CI: [1.8, 19.5]
Comparison: BCAR at Month 690% CI: [-3.6, 12.3]
Comparison: BCAR at Month 690% CI: [-1.7, 14.6]
Comparison: BCAR at Month 1290% CI: [3, 21]
Comparison: BCAR at Month 1290% CI: [-3.6, 12.3]
Comparison: BCAR at Month 1290% CI: [-0.6, 16.2]
Secondary
Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12
Patients who received immunosuppressive medications for the treatment of suspected or BCAR were considered to have a clinically-treated acute rejection.
Time frame: 6 months and 12 months
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12 | Month 6 | 19.0 percentage of participants |
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12 | Month 12 | 20.3 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12 | Month 12 | 35.1 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12 | Month 6 | 33.8 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12 | Month 6 | 29.3 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12 | Month 12 | 30.7 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12 | Month 6 | 23.1 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12 | Month 12 | 23.1 percentage of participants |
Secondary
Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review
Efficacy failure is defined as death, graft failure (permanent return to dialysis \[\>30 days\] or retransplant), BCAR according to central review, or lost to follow-up.
Time frame: 6 months and 12 months
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review | Month 6 | 11.4 percentage of participants |
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review | Month 12 | 19.0 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review | Month 12 | 26.0 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review | Month 6 | 22.1 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review | Month 6 | 16.0 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review | Month 12 | 21.3 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review | Month 6 | 20.5 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review | Month 12 | 25.6 percentage of participants |
Comparison: Efficacy Failure at Month 690% CI: [0.9, 20.4]
Comparison: Efficacy Failure at Month 690% CI: [-4.5, 13.7]
Comparison: Efficacy Failure at Month 690% CI: [-0.4, 18.7]
Comparison: Efficacy Failure at Month 1290% CI: [-4, 18]
Comparison: Efficacy Failure at Month 1290% CI: [-8.3, 13]
Comparison: Efficacy Failure at Month 1290% CI: [-4.2, 17.6]
Secondary
Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review
Efficacy failure is defined as death, graft failure (permanent return to dialysis \[\>30 days\] or retransplant), BCAR according to local review, or lost to follow-up.
Time frame: 6 months and 12 months
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review | Month 6 | 15.2 percentage of participants |
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review | Month 12 | 25.3 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review | Month 12 | 33.8 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review | Month 6 | 29.9 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review | Month 6 | 22.7 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review | Month 12 | 29.3 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review | Month 6 | 23.1 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review | Month 12 | 29.5 percentage of participants |
Comparison: Efficacy Failure at Month 690% CI: [3.8, 25.5]
Comparison: Efficacy Failure at Month 690% CI: [-2.9, 17.8]
Comparison: Efficacy Failure at Month 690% CI: [-2.4, 18.2]
Comparison: Efficacy Failure at Month1290% CI: [-3.5, 20.4]
Comparison: Efficacy Failure at Month 1290% CI: [-7.8, 15.8]
Comparison: Efficacy Failure at Month1290% CI: [-7.5, 15.9]
Secondary
Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12
All participants were evaluated for the incidence of multiple rejection episodes (clinically treated and/or BCAR as assessed by the local reviewer) through 6 months and 12 months.
Time frame: 6 months and 12 months
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12 | Month 6 | 1.3 percentage of participants |
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12 | Month 12 | 1.3 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12 | Month 12 | 7.8 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12 | Month 6 | 3.9 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12 | Month 6 | 4.0 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12 | Month 12 | 4.0 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12 | Month 6 | 2.6 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12 | Month 12 | 3.8 percentage of participants |
Secondary
Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review
Rejection episodes were confirmed by biopsy by the central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Time frame: 6 months and 12 months
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review | Month 6 | 7.7 percentage of participants |
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review | Month 12 | 7.7 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review | Month 12 | 18.4 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review | Month 6 | 17.0 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review | Month 6 | 12.1 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review | Month 12 | 12.1 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review | Month 6 | 14.2 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review | Month 12 | 15.5 percentage of participants |
Comparison: T-cell Mediated BCAR at Month 690% CI: [0.7, 18]
Comparison: T-cell Mediated BCAR at Month 690% CI: [-3.6, 12.3]
Comparison: T-cell Mediated BCAR at Month 690% CI: [-1.7, 14.6]
Comparison: T-cell Mediated BCAR at Month 1290% CI: [1.8, 19.5]
Comparison: T-cell Mediated BCAR at Month 1290% CI: [-3.6, 12.3]
Comparison: T-cell Mediated BCAR at Month 1290% CI: [-0.6, 16.2]
Secondary
Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Time frame: 6 months and 12 months
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review | Month 6 | 12.7 percentage of participants |
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review | Month 12 | 14.0 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review | Month 12 | 27.7 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review | Month 6 | 25.0 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review | Month 6 | 18.8 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review | Month 12 | 18.8 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review | Month 6 | 16.7 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review | Month 12 | 18.1 percentage of participants |
Comparison: T-cell Mediated BCAR at Month 690% CI: [2, 22.5]
Comparison: T-cell Mediated BCAR at Month 690% CI: [-3.6, 15.8]
Comparison: T-cell Mediated BCAR at Month 690% CI: [-5.3, 13.3]
Comparison: T-cell Mediated BCAR at Month 1290% CI: [3, 24.3]
Comparison: T-cell Mediated BCAR at Month 1290% CI: [-5.1, 14.6]
Comparison: T-cell Mediated BCAR at Month 1290% CI: [-5.6, 13.8]
Secondary
Percentage of Participants With Treatment Failure at Month 6 and 12
Treatment failure was defined as death, graft loss, BCAR (local review), lost to follow-up or early discontinuation of treatment regimen. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Time frame: 6 months and 12 months
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With Treatment Failure at Month 6 and 12 | Month 6 | 26.6 percentage of participants |
| Tacrolimus/MMF/Basiliximab | Percentage of Participants With Treatment Failure at Month 6 and 12 | Month 12 | 35.5 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With Treatment Failure at Month 6 and 12 | Month 12 | 45.5 percentage of participants |
| Alefacept QW/Tacrolimus/MMF | Percentage of Participants With Treatment Failure at Month 6 and 12 | Month 6 | 37.7 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With Treatment Failure at Month 6 and 12 | Month 12 | 45.2 percentage of participants |
| Alefacept QW/Tacrolimus | Percentage of Participants With Treatment Failure at Month 6 and 12 | Month 6 | 38.4 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With Treatment Failure at Month 6 and 12 | Month 6 | 29.5 percentage of participants |
| Alefacept QOW/Tacrolimus/MMF | Percentage of Participants With Treatment Failure at Month 6 and 12 | Month 12 | 34.7 percentage of participants |
Comparison: Treatment Failure at Month 690% CI: [-1.1, 23.3]
Comparison: Treatment Failure at Month 690% CI: [-0.7, 24.2]
Comparison: Treatment Failure at Month 690% CI: [-8.9, 14.7]
Comparison: Treatment Failure at Month 1290% CI: [-2.9, 22.8]
Comparison: Treatment Failure at Month 1290% CI: [-3.3, 22.8]
Comparison: Treatment Failure at Month 1290% CI: [-13.3, 11.7]
Secondary
Time to First BCAR Assessed by Central Review
The time to first BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis.
Time frame: 12 months
Population: Full analysis set with a BCAR as assessed by the central reviewer
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tacrolimus/MMF/Basiliximab | Time to First BCAR Assessed by Central Review | 19 days |
| Alefacept QW/Tacrolimus/MMF | Time to First BCAR Assessed by Central Review | 10 days |
| Alefacept QW/Tacrolimus | Time to First BCAR Assessed by Central Review | 12 days |
| Alefacept QOW/Tacrolimus/MMF | Time to First BCAR Assessed by Central Review | 11.5 days |
Secondary
Time to First BCAR Assessed by Local Review
The time to first BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis.
Time frame: 12 months
Population: Full analysis set with a BCAR assessed by local review
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tacrolimus/MMF/Basiliximab | Time to First BCAR Assessed by Local Review | 9 days |
| Alefacept QW/Tacrolimus/MMF | Time to First BCAR Assessed by Local Review | 12 days |
| Alefacept QW/Tacrolimus | Time to First BCAR Assessed by Local Review | 19 days |
| Alefacept QOW/Tacrolimus/MMF | Time to First BCAR Assessed by Local Review | 12.5 days |
Secondary
Time to First T-cell Mediated BCAR Assessed by Central Review
The time to first T-cell mediated BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a T-cell mediated BCAR are included in the analysis.
Time frame: 12 months
Population: Full analysis set with a T-cell mediated BCAR as assessed by the central reviewer
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tacrolimus/MMF/Basiliximab | Time to First T-cell Mediated BCAR Assessed by Central Review | 19 days |
| Alefacept QW/Tacrolimus/MMF | Time to First T-cell Mediated BCAR Assessed by Central Review | 10 days |
| Alefacept QW/Tacrolimus | Time to First T-cell Mediated BCAR Assessed by Central Review | 12 days |
| Alefacept QOW/Tacrolimus/MMF | Time to First T-cell Mediated BCAR Assessed by Central Review | 11.5 days |
Secondary
Time to First T-cell Mediated BCAR Assessed by Local Review
The time to first T-cell mediated BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1.
Time frame: 12 months
Population: Full analysis set with a T-cell mediated BCAR as assessed by local review
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tacrolimus/MMF/Basiliximab | Time to First T-cell Mediated BCAR Assessed by Local Review | 9 days |
| Alefacept QW/Tacrolimus/MMF | Time to First T-cell Mediated BCAR Assessed by Local Review | 12 days |
| Alefacept QW/Tacrolimus | Time to First T-cell Mediated BCAR Assessed by Local Review | 18 days |
| Alefacept QOW/Tacrolimus/MMF | Time to First T-cell Mediated BCAR Assessed by Local Review | 12.5 days |