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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002092-14 | EudraCT Number |
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The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and steroids in the prevention of kidney transplant rejection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment. |
|
| Alefacept | Experimental | Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alefacept | Drug | IV and subcutaneous injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Biopsy-confirmed Acute T-cell Mediated Rejection at Month 6 Assessed by Local Review | Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:
A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Biopsy Confirmed Antibody-Mediated Acute Rejection at Month 6 | Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification: Acute antibody-mediated rejection - documented anti-donor antibody ('suspicious for' if antibody not demonstrated):
A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed antibody-mediated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna | 1090 | Austria | ||||
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Of 221 patients screened, 218 patients were enrolled into the study at 30 centers across 12 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| placebo | Drug | IV and subcutaneous injection |
|
| Tacrolimus | Drug | The initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery. |
|
| Mycophenolate Mofetil | Drug | Mycophenolic mofetil was administered as 750 mg twice per day orally |
|
| Steroids | Drug | Methylprednisolone or equivalent: Day 0: 500 - 1000 mg IV bolus Day 1: 125 - 250 mg IV bolus Prednisone or equivalent: Days 2 - 14: 20 - 30 mg orally Days 15 - 28: 10 - 20 mg orally Days 29 - 60: 10 - 15 mg orally Days 61 onwards: 5 - 10 mg orally |
|
| 6 months |
| Percentage of Participants With Biopsy Confirmed Acute Rejection (T-Cell Mediated or Antibody Mediated) at Month 6 | Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated or antibody-mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. | 6 months |
| Percentage of Participants With Biopsy Confirmed Acute Mixed T-Cell Mediated and Antibody-Mediated Rejection at Month 6 | Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed acute mixed T-cell mediated and antibody-mediated rejections within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. | 6 months |
| Percentage of Participants With Acute Rejection Diagnosed by Signs and Symptoms at Month 6 | Acute rejection diagnosed by signs and symptoms, including biopsy-confirmed or suspected (not confirmed by biopsy - i.e. no biopsy was performed or biopsy did not confirm an acute T-cell mediated rejection). The Kaplan-Meier estimate of acute rejection diagnosed by signs and symptoms within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. | 6 months |
| Percentage of Participants With Clinically Treated Acute Rejection at Month 6 | Patients who received immunosuppressive medications for the treatment of suspected or biopsy-confirmed acute rejections were considered to have a clinically-treated acute rejection. The Kaplan-Meier estimate of clinically treated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit. | 6 months |
| Percentage of Participants With Steroid-resistant Acute Rejection at Month 6 | A steroid-resistant acute rejection is defined as a rejection episode which did not resolve following treatment with corticosteroids. In the case that a rejection episode was not treated with corticosteroids first but only with antibodies, it was included in this category. The Kaplan-Meier estimate of steroid-resistant acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. | 6 months |
| Percentage of Participants With Biopsy-Confirmed Acute T-cell Mediated Rejection as Assessed by Central Review at Month 6 | Biopsies were graded by the central reviewer according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. | 6 months |
| Patient Survival | Patient survival is any participant known to be alive at Month 6. The Kaplan-Meier estimate of patient survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment. | 6 months |
| Graft Survival | Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months. Graft loss is defined as re-transplantation, nephrectomy, death or as dialysis ongoing at end of study or at discontinuation of the participant unless superseded by follow-up information. The Kaplan-Meier estimate of graft survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment. | 6 months |
| Maximum Histological Grade of All Biopsies After Local Review | The grade of acute rejection was classified according to Banff 97/05 updated version. If a patient had more than 1 rejection episode, the episode with the most severe grade was used. Acute T-cell mediated rejection:
Acute antibody-mediated rejection:
| 6 months |
| Percentage of Participants With Anti-Lymphocyte Antibody Therapy for Treatment of Rejection at Month 6 | The Kaplan-Meier estimate of anti-lymphocyte antibody therapy for acute rejection (clinically-treated or biopsy-confirmed) within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit. | 6 months |
| Change From Month 1 in Serum Creatinine | Month 1, 3, and 6 |
| Change From Month 1 in Glomerular Filtration Rate (GFR) | The GFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula. | Month 1, 3, and 6 |
| Change From Month 1 in Creatinine Clearance | The creatinine clearance was calculated according to the Cockcroft-Gault formula. | Month 1, 3, and 6 |
| GFR Measured by Iothalamate Clearance at Month 6 | GFR measured using the iothalamate clearance method and determined by a central laboratory. | Month 6 |
| Percentage of Participants With Efficacy Failure at Month 6 | Efficacy failure is defined as death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading or lost to follow-up. The Kaplan-Meier estimate of efficacy failure within the first 6 months following transplantation is reported. | 6 months |
| Percentage of Participants With Delayed Graft Function | Delayed graft function was defined as the requirement for dialysis within the first week post-transplant. | 1 week |
| Percentage of Participants With Treatment Failure at Month 6 | Treatment failure is defined as efficacy failure (death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading, lost to follow-up) or early discontinuation of alefacept/placebo at any time (during the 12-week administration period) for any reason. The Kaplan-Meier estimate of treatment failure within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit. | 6 months |
| Number of Participants With Adverse Events | Causally related was defined as adverse events (AEs) assessed by the Investigator as possibly or probably related to study drug or records where the relationship was missing. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose:
All rejections and any BK virus, Epstein Barr virus and/or cytomegalovirus infection had to be reported as an SAE | 6 Months |
| Brussels |
| 1070 |
| Belgium |
| Brussels | 1200 | Belgium |
| Ghent | 9000 | Belgium |
| Leuven | 3000 | Belgium |
| Liège | 4000 | Belgium |
| Prague | 140 21 | Czechia |
| Créteil | 94010 | France |
| Le Kremlin-Bicêtre | 94275 | France |
| Montpellier | 34295 | France |
| Nantes | 44093 | France |
| Nice | 6002 | France |
| Paris | 75475 | France |
| Toulouse | 31054 | France |
| Bochum | 44892 | Germany |
| Regensburg | 93053 | Germany |
| Budapest | 1082 | Hungary |
| Bologna | 40138 | Italy |
| Padova | 35128 | Italy |
| Rome | 00168 | Italy |
| Siena | 53100 | Italy |
| Maastricht | 6229 | Netherlands |
| Bydgoszcz | 85-094 | Poland |
| Poznan | 60-479 | Poland |
| Szczecin | 70-111 | Poland |
| Barcelona | 8036 | Spain |
| Llobregat | 8907 | Spain |
| Madrid | 28041 | Spain |
| Málaga | 29010 | Spain |
| Santander | 39008 | Spain |
| Gothenburg | 41345 | Sweden |
| Uppsala | 75185 | Sweden |
| Manchester | M13 9WL | United Kingdom |
| Alefacept |
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment. |
| Received Treatment |
|
| Completed 12 Weeks of Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized patients who took at least 1 dose of study drug (Safety Analysis Set).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment. |
| BG001 | Alefacept | Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Biopsy-confirmed Acute T-cell Mediated Rejection at Month 6 Assessed by Local Review | Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:
A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. | Full analysis set (all randomized and transplanted participants who received at least 1 dose of study drug) | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Biopsy Confirmed Antibody-Mediated Acute Rejection at Month 6 | Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification: Acute antibody-mediated rejection - documented anti-donor antibody ('suspicious for' if antibody not demonstrated):
A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed antibody-mediated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Biopsy Confirmed Acute Rejection (T-Cell Mediated or Antibody Mediated) at Month 6 | Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated or antibody-mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Biopsy Confirmed Acute Mixed T-Cell Mediated and Antibody-Mediated Rejection at Month 6 | Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed acute mixed T-cell mediated and antibody-mediated rejections within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Acute Rejection Diagnosed by Signs and Symptoms at Month 6 | Acute rejection diagnosed by signs and symptoms, including biopsy-confirmed or suspected (not confirmed by biopsy - i.e. no biopsy was performed or biopsy did not confirm an acute T-cell mediated rejection). The Kaplan-Meier estimate of acute rejection diagnosed by signs and symptoms within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinically Treated Acute Rejection at Month 6 | Patients who received immunosuppressive medications for the treatment of suspected or biopsy-confirmed acute rejections were considered to have a clinically-treated acute rejection. The Kaplan-Meier estimate of clinically treated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months |
|
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| Secondary | Percentage of Participants With Steroid-resistant Acute Rejection at Month 6 | A steroid-resistant acute rejection is defined as a rejection episode which did not resolve following treatment with corticosteroids. In the case that a rejection episode was not treated with corticosteroids first but only with antibodies, it was included in this category. The Kaplan-Meier estimate of steroid-resistant acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Biopsy-Confirmed Acute T-cell Mediated Rejection as Assessed by Central Review at Month 6 | Biopsies were graded by the central reviewer according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months |
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| Secondary | Patient Survival | Patient survival is any participant known to be alive at Month 6. The Kaplan-Meier estimate of patient survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months |
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| Secondary | Graft Survival | Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months. Graft loss is defined as re-transplantation, nephrectomy, death or as dialysis ongoing at end of study or at discontinuation of the participant unless superseded by follow-up information. The Kaplan-Meier estimate of graft survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Histological Grade of All Biopsies After Local Review | The grade of acute rejection was classified according to Banff 97/05 updated version. If a patient had more than 1 rejection episode, the episode with the most severe grade was used. Acute T-cell mediated rejection:
Acute antibody-mediated rejection:
| Full analysis set | Posted | Number | percentage of participants | 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Lymphocyte Antibody Therapy for Treatment of Rejection at Month 6 | The Kaplan-Meier estimate of anti-lymphocyte antibody therapy for acute rejection (clinically-treated or biopsy-confirmed) within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months |
|
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| Secondary | Change From Month 1 in Serum Creatinine | Full analysis set participants with available data at Month 1 (99 and 94 participants in each treatment group respectively) and at Month 3 and Month 6 (indicated by "n"). | Posted | Mean | Standard Deviation | µmol/L | Month 1, 3, and 6 |
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| Secondary | Change From Month 1 in Glomerular Filtration Rate (GFR) | The GFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula. | Full analysis set participants with available data at Month 1 (98, 93 participants respectively) and at Month 3 and Month 6 (indicated by "n"). | Posted | Mean | Standard Deviation | mL/min/1.73 m² | Month 1, 3, and 6 |
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| Secondary | Change From Month 1 in Creatinine Clearance | The creatinine clearance was calculated according to the Cockcroft-Gault formula. | Full analysis set participants with available data at Month 1 (90, 84) and at Month 3 and Month 6 (indicated by "n"). | Posted | Mean | Standard Deviation | mL/minute | Month 1, 3, and 6 |
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| Secondary | GFR Measured by Iothalamate Clearance at Month 6 | GFR measured using the iothalamate clearance method and determined by a central laboratory. | Full analysis set participants with available data | Posted | Mean | Standard Deviation | mL/minute | Month 6 |
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| Secondary | Percentage of Participants With Efficacy Failure at Month 6 | Efficacy failure is defined as death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading or lost to follow-up. The Kaplan-Meier estimate of efficacy failure within the first 6 months following transplantation is reported. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Delayed Graft Function | Delayed graft function was defined as the requirement for dialysis within the first week post-transplant. | Full analysis set | Posted | Number | percentage of participants | 1 week |
|
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| Secondary | Percentage of Participants With Treatment Failure at Month 6 | Treatment failure is defined as efficacy failure (death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading, lost to follow-up) or early discontinuation of alefacept/placebo at any time (during the 12-week administration period) for any reason. The Kaplan-Meier estimate of treatment failure within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | Causally related was defined as adverse events (AEs) assessed by the Investigator as possibly or probably related to study drug or records where the relationship was missing. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose:
All rejections and any BK virus, Epstein Barr virus and/or cytomegalovirus infection had to be reported as an SAE | Safety analysis set (all randomized participants who received at least one dose of study drug). | Posted | Number | participants | 6 Months |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment. | 62 | 107 | 98 | 107 | ||
| EG001 | Alefacept | Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment. | 57 | 105 | 92 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cytomegalovirus infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Bk virus infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Epstein-barr virus infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Wound abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Polyomavirus-associated nephropathy | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Arteriovenous fistula site infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Erythema infectiosum | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Renal cyst infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal haemorrhage | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Microalbuminuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal ischaemia | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Focal segmental glomerulosclerosis | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal vein thrombosis | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Chronic allograft nephropathy | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Graft loss | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Postoperative hernia | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombosis in device | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Graft dysfunction | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Transplant failure | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Arteriovenous graft thrombosis | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Perinephric collection | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Perirenal haematoma | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary anastomotic leak | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Histology abnormal | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Duodenogastric reflux | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Phaeochromocytoma malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Post transplant lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Iliac artery stenosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperparathyroidism tertiary | Endocrine disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Drug intolerance | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Reversible posterior leukoencephalopathy syndrome | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Epididymitis | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data or 12 months after data-lock, whichever is first. Sponsor must receive a site's manuscript at least 30 days prior to publication for review and comment. Sponsor may delay the publication temporarily to seek patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Medical Science | Astellas Pharma Europe B.V | Astellas.resultsdisclosure@astellas.com |
| ID | Term |
|---|---|
| D000077944 | Alefacept |
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D018968 | CD58 Antigens |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008565 | Membrane Proteins |
| D011993 | Recombinant Fusion Proteins |
| D011994 | Recombinant Proteins |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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