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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002090-21 | EudraCT Number |
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Patients who undergo a kidney transplant require prolonged therapy with drugs that suppress the immune system (called immunosuppressive regimens) to stop the immune system from attacking the transplanted kidney in order to limit damage to or the possibility of rejecting the transplanted kidney. The purpose of this study is to evaluate benefits and risks of two immunosuppressive regimens (belatacept with everolimus or tacrolimus with mycophenolate mofetil) following thymoglobulin induction and rapid corticosteroid withdrawal.
Calcineurin inhibitor (CNI)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belatacept + Everolimus | Experimental | Thymoglobulin (i.v. infusion) induction, daily (or less frequently, as tolerated) not to exceed 10 days, to reach a total cumulative dose between 3.0 and 5.5 mg/kg; belatacept (infusion) regimen of 10 mg/kg i.v. on Day 1, Weeks 1, 2, 4, 8 and 12 post transplant and then a maintenance dose of 5 mg/kg every 4 weeks after 12 weeks post transplant; everolimus (tablet) daily dosing at 3.0 mg/day, 2 divided doses, starting on Day 3 dosing adjusted based on blood sample tests; methylprednisolone (infusion) prior to each Thymoglobulin infusion and prednisone (tablet), once methylprednisolone is no longer needed. (Corticosteroids to be discontinued by Day 7 or as soon thereafter as thymoglobulin infusions are completed) |
|
| Tacrolimus + Mycophenolate mofetil | Experimental | Thymoglobulin (i.v. infusion) induction, daily (or less frequently, as tolerated) not to exceed 10 days, to reach a total cumulative dose between 3.0 and 5.5 mg/kg; tacrolimus (tablet) daily dosing beginning at 0.1 mg/kg/day, then adjusted based on blood sample tests; MMF (tablet) daily dosing between 0.5 to 2.0 g/day divided in 2 doses (up to 3 g/day if African Americans/Blacks); methylprednisolone (infusion) prior to each Thymoglobulin infusion and prednisone (tablet), once methylprednisolone is no longer needed. (Corticosteroids to be discontinued by Day 7 or as soon thereafter as thymoglobulin infusions are completed) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymoglobulin | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months | Number of Participants with Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6 Months | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months | Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6, 12 and 24 Months Change in the incidence of CSBPAR at 6, 12 and 24 months post transplant, in the belatacept + EVL(Treatment A) as compared to TAC + MMF (Treatment B). | Up to 24 Months |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Institute Of Renal Research | San Diego | California | 92123 | United States | ||
| California Pacific Medical Center |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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58 participants randomized and treated
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A | BELA + EVL |
| FG001 | Treatment B | TAC + MMF |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 14, 2017 | Oct 14, 2020 |
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| Belatacept |
| Drug |
|
|
| mycophenolate mofetil(MMF) | Drug |
|
|
| Corticosteroids | Drug |
|
|
| Everolimus(EVL) | Drug |
|
|
| Tacrolimus(TAC) | Drug |
|
|
| Time to Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR). |
Time to Clinically suspected biopsy proven acute rejection |
| Up to 24 Months |
| Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | Treatment differences in the severity grades to treat all episodes of CSBPAR at 6, 12, and 24 months post-transplant. Type 1A - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/Tubular cross section or group of 10 Tubular cell). Type 1B - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/Tubular cross section or group of 10 Tubular cell).Type 2A - Cases with mild to moderate intimal arteritis.Type 2B - Cases with severe intimal arteritis comprising >25% of the luminal area. Type 3 - Cases with "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (v3 with accompanying lymphocytic inflammation) | At 6, 12 and 24 Months |
| Treatment Differences in Therapeutic Modalities | Treatment Received for Biopsy Proven Acute Rejection (Banff Grade IA or Higher), or Humoral (Antibody Mediated) Rejection Treatment regimen: Categorical analysis of CSBPAR episodes by treatment received. | at 6, 12 and 24 Months |
| Number of Participants Who Survive With a Functioning Graft | Number of all participants who survive with a functioning graft at 6, 12 and 24 months post transplant | At 6, 12 and 24 months |
| Number of Participants Deaths Post Transplant | Number of participant deaths at 6, 12 and 24 months post transplant | up to 24 months |
| Number of Participants Who Experience Graft Loss Post Transplant | Number of all participants who experience graft loss at 6, 12 and 24 months post transplant | At 6, 12 and 24 months |
| Time to Event: Graft Loss and Death | The Number of days to participant Graft Loss and death for any reason | Up to 728 Days |
| Absolute Calculated Glomerular Filtration Rate (cGFR): Mean | Absolute (mean and median) cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula | Up 24 Months post-transplant |
| Median Calculated Glomerular Filtration Rate (cGFR) | Median cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula | Up 24 Months post-transplant |
| Mean Change From Month 3 in cGFR | The mean change from Month 3 cGFR at 3, 6, 12 and 24 months post-transplant | Up 24 Months post-transplant |
| Urine Protein Creatinine Ratio (UPr/Cr) | Urine protein to creatinine ratio (UPr/Cr) at 3, 6, 12 and 24 months post-transplant. | Up 24 Months post-transplant |
| Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | Percentage of participants with, and titers of pre-existing (pre-transplant) DSA on Day 1 (pre-transplant, pre-dose), and at Months 12 and 24 posttransplant | Up to 24 Months |
| Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | Characterization of any de novo DSA detected by IgM and IgG subclasses, and by the presence or absence of complement fixing properties. | Up to 24 Months |
| Percentage of Participants With Adverse Events (AEs) | Percentage of participants with AEs up to 24 months post-transplant | Up to 24 months Post-Transplant |
| Percentage of Participants With Serious Adverse Events (SAEs) | Percentage of participants with SAEs up to 24 months post-transplant | Up to 24 months Post-Transplant |
| Percentage of Participants With Events of Special Interest (ESIs) | Percentage of participants which have one of the following events of special interest: Serious Infections Post-Transplant Lymphoproliferative Disorder (PTLD) Progressive multifocal leukoencephalopathy (PML) Malignancies (Other than PTLD) including non-melanoma skin carcinomas (Malignancies) Tuberculosis Infections Central Nervous System (CNS) Infections Viral Infections Infusion Related reactions within 24 hours since belatacept infusion | Up to 24 Months |
| Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Percentage of participants with laboratory tests with marked laboratory abnormalities | At 24 Months |
| Mean and Mean Change From Baseline in Blood Glucose | Mean fasting blood glucose levels, and mean changes from baseline values at Months 6, 12 and 24 months post- transplant | Up to 24 months |
| Mean and Mean Change From Baseline in Whole Blood HbA1c | Mean whole blood HbA1C concentrations, and mean changes from baseline values at Months 6, 12 and 24 months post-transplant. | Up to 24 months |
| Percentage of Participants With New Onset Diabetes After Transplant | Percentage of participants with New Onset Diabetes After Transplantation (NODAT) at 6, 12, and 24 months post-transplant. | up to 24 months |
| Absolute Values of Blood Pressure: Mean | Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant; | Up to 24 Months |
| Absolute Values of Blood Pressure: Median | Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant; | Up to 24 Months |
| Mean Changes From Baseline Values for Blood Pressure | Mean changes from baseline values for SBP and DBP at 6, 12 and 24 months post-transplant | Up to 24 Months |
| Absolute Values of Fasting Lipid Values: Mean | Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following: Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG) | Up to 24 Months |
| Absolute Values of Fasting Lipid Values: Median | Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following: Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG) | Up to 24 Months |
| Mean Changes From Baseline Values of Lipid Values | Mean changes from baseline values in the following: Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG) | at months 12 and 24 |
| San Francisco |
| California |
| 94115 |
| United States |
| University Of Colorado | Aurora | Colorado | 80045 | United States |
| Yale University | New Haven | Connecticut | 06519 | United States |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Emory Univeristy | Atlanta | Georgia | 30322 | United States |
| University Of Illinois | Chicago | Illinois | 60612 | United States |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| Erie County Medical Center | Buffalo | New York | 14215 | United States |
| Wake Forest University School Of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| Central PA Transplant Foundation | Harrisburg | Pennsylvania | 17104 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Virginia | Charlottesville | Virginia | 22908-0709 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Swedish Medical Center - Swedish Colon and Rectal Clinic - First Hill (Northwest Colon and Rectal Cl | Seattle | Washington | 98104 | United States |
| Sanatorio Parque S.A. | Rosario | Santa Fe Province | 2000 | Argentina |
| Clinica Privada Velez Sarsfield | Córdoba | 5016 | Argentina |
| Clinica De Nefrologia, Urologia Y Enf. Cardiovasculares | Sante Fe | 3000 | Argentina |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomized, Transplanted and Treated Population (ITT)
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment A | BELA + EVL |
| BG001 | Treatment B | TAC + MMF |
| 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 |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months | Number of Participants with Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6 Months | ITT Population | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 Months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months | Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6, 12 and 24 Months Change in the incidence of CSBPAR at 6, 12 and 24 months post transplant, in the belatacept + EVL(Treatment A) as compared to TAC + MMF (Treatment B). | ITT Population | Posted | Number | 95% Confidence Interval | Percentage of CSBPAR | Up to 24 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR). | Time to Clinically suspected biopsy proven acute rejection | Participants with a CSBPAR | Posted | Mean | Full Range | Months | Up to 24 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection | Treatment differences in the severity grades to treat all episodes of CSBPAR at 6, 12, and 24 months post-transplant. Type 1A - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/Tubular cross section or group of 10 Tubular cell). Type 1B - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/Tubular cross section or group of 10 Tubular cell).Type 2A - Cases with mild to moderate intimal arteritis.Type 2B - Cases with severe intimal arteritis comprising >25% of the luminal area. Type 3 - Cases with "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (v3 with accompanying lymphocytic inflammation) | ITT Population | Posted | Number | Percentage of Participants | At 6, 12 and 24 Months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Treatment Differences in Therapeutic Modalities | Treatment Received for Biopsy Proven Acute Rejection (Banff Grade IA or Higher), or Humoral (Antibody Mediated) Rejection Treatment regimen: Categorical analysis of CSBPAR episodes by treatment received. | All Randomized, Transplanted and Treated Participants | Posted | Number | Percentage of participants with CSBPARs | at 6, 12 and 24 Months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Survive With a Functioning Graft | Number of all participants who survive with a functioning graft at 6, 12 and 24 months post transplant | All Treated Participants | Posted | Count of Participants | Participants | At 6, 12 and 24 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Deaths Post Transplant | Number of participant deaths at 6, 12 and 24 months post transplant | All Treated Participants | Posted | Count of Participants | Participants | up to 24 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experience Graft Loss Post Transplant | Number of all participants who experience graft loss at 6, 12 and 24 months post transplant | ITT Population | Posted | Count of Participants | Participants | At 6, 12 and 24 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Time to Event: Graft Loss and Death | The Number of days to participant Graft Loss and death for any reason | All Treated Participants | Posted | Number | Days | Up to 728 Days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Absolute Calculated Glomerular Filtration Rate (cGFR): Mean | Absolute (mean and median) cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula | ITT Population | Posted | Mean | 95% Confidence Interval | mL/min/1.73 m^2 | Up 24 Months post-transplant |
|
| |||||||||||||||||||||||||||||
| Secondary | Median Calculated Glomerular Filtration Rate (cGFR) | Median cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula | ITT Population | Posted | Median | Full Range | mL/min/1.73 m^2 | Up 24 Months post-transplant |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Change From Month 3 in cGFR | The mean change from Month 3 cGFR at 3, 6, 12 and 24 months post-transplant | ITT Population | Posted | Mean | 95% Confidence Interval | mL/min/1.73 m^2 | Up 24 Months post-transplant |
|
| |||||||||||||||||||||||||||||
| Secondary | Urine Protein Creatinine Ratio (UPr/Cr) | Urine protein to creatinine ratio (UPr/Cr) at 3, 6, 12 and 24 months post-transplant. | ITT Population | Posted | Mean | 95% Confidence Interval | mg Protein/mg Creatinine | Up 24 Months post-transplant |
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| Secondary | Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) | Percentage of participants with, and titers of pre-existing (pre-transplant) DSA on Day 1 (pre-transplant, pre-dose), and at Months 12 and 24 posttransplant | As Treated Population | Posted | Number | Percentage of Participants | Up to 24 Months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) | Characterization of any de novo DSA detected by IgM and IgG subclasses, and by the presence or absence of complement fixing properties. | As Treated Population | Posted | Number | Percentage | Up to 24 Months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) | Percentage of participants with AEs up to 24 months post-transplant | As Treated Population | Posted | Number | Percentage of participants with AEs | Up to 24 months Post-Transplant |
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| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Serious Adverse Events (SAEs) | Percentage of participants with SAEs up to 24 months post-transplant | As Treated Population | Posted | Number | Percentage of participants with SAEs | Up to 24 months Post-Transplant |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Events of Special Interest (ESIs) | Percentage of participants which have one of the following events of special interest: Serious Infections Post-Transplant Lymphoproliferative Disorder (PTLD) Progressive multifocal leukoencephalopathy (PML) Malignancies (Other than PTLD) including non-melanoma skin carcinomas (Malignancies) Tuberculosis Infections Central Nervous System (CNS) Infections Viral Infections Infusion Related reactions within 24 hours since belatacept infusion | As Treated Population | Posted | Number | Percentage of participants with ESIs | Up to 24 Months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Particpants With Laboratory Test Abnormalities (LTAs) | Percentage of participants with laboratory tests with marked laboratory abnormalities | As Treated Population | Posted | Number | Percentage of participants | At 24 Months |
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| ||||||||||||||||||||||||||||||
| Secondary | Mean and Mean Change From Baseline in Blood Glucose | Mean fasting blood glucose levels, and mean changes from baseline values at Months 6, 12 and 24 months post- transplant | ITT Population | Posted | Mean | 95% Confidence Interval | mg/dL | Up to 24 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean and Mean Change From Baseline in Whole Blood HbA1c | Mean whole blood HbA1C concentrations, and mean changes from baseline values at Months 6, 12 and 24 months post-transplant. | ITT Population | Posted | Mean | 95% Confidence Interval | mg/dL | Up to 24 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With New Onset Diabetes After Transplant | Percentage of participants with New Onset Diabetes After Transplantation (NODAT) at 6, 12, and 24 months post-transplant. | ITT Population | Posted | Number | 95% Confidence Interval | Percentage of participants | up to 24 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Absolute Values of Blood Pressure: Mean | Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant; | ITT Population | Posted | Mean | 95% Confidence Interval | mmHg | Up to 24 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Absolute Values of Blood Pressure: Median | Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant; | ITT Population | Posted | Median | Full Range | mmHg | Up to 24 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Changes From Baseline Values for Blood Pressure | Mean changes from baseline values for SBP and DBP at 6, 12 and 24 months post-transplant | ITT Population | Posted | Mean | 95% Confidence Interval | mmHg | Up to 24 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Absolute Values of Fasting Lipid Values: Mean | Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following: Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG) | ITT Population | Posted | Mean | 95% Confidence Interval | mg/dL | Up to 24 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Absolute Values of Fasting Lipid Values: Median | Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following: Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG) | ITT Population | Posted | Median | Full Range | mg/dL | Up to 24 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Changes From Baseline Values of Lipid Values | Mean changes from baseline values in the following: Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG) | ITT Population | Posted | Mean | 95% Confidence Interval | mg/dL | at months 12 and 24 |
|
|
Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
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 | BELA+EVL | BELA + EVL | 0 | 25 | 13 | 25 | 25 | 25 |
| EG001 | TAC+MMF | TAC + MMF | 0 | 33 | 20 | 33 | 30 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arteriospasm coronary | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Intra-abdominal fluid collection | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Intra-abdominal haematoma | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Renal transplant failure | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Osteomyelitis acute | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Renal graft infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Post transplant lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Central nervous system vasculitis | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cerebellar ataxia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bladder stenosis | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Perinephric collection | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ureteral necrosis | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dry gangrene | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Iliac artery occlusion | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Graft complication | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Donor specific antibody present | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Perinephric collection | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
One participant with BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period. Due to this, time to CSBPAR was performed using this inaccurate population, therefore inaccurate data is not presented.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2019 | Oct 14, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| C512542 | thymoglobulin |
| D000069594 | Abatacept |
| D009173 | Mycophenolic Acid |
| D000305 | Adrenal Cortex Hormones |
| D008775 | Methylprednisolone |
| D011241 | Prednisone |
| D000068338 | Everolimus |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
Not provided
Not provided
| ≥ 65 |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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