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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005257-31 | EudraCT Number |
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The purpose of this study is to evaluate how well adolescent kidney transplant patients tolerate a single dose of belatacept they receive at least 6 months after transplant surgery, and how their body handles the drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belatacept | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belatacept | Drug | Single intravenous infusion of belatacept, 7.5 mg/kg |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of Belatacept | Cmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to "zero" which was 0.003 micrograms per milliliter (ug/mL). Cmax was measured in micrograms per milliliter. | Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57 |
| Time of Maximum Observed Plasma Concentration (Tmax) of Belatacept | Tmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to "zero" which was 0.003 micrograms per milliliter (ug/mL). Tmax was measured in hours (h). | Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57 |
| Half-Life of Elimination (T-Half) of Belatacept | T-HALF was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to "zero" which was 0.003 micrograms per milliliter (ug/mL). T-HALF was measured in hours (h). | Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57 |
| Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC (0-T)) and Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Belatacept |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Death, Serious Adverse Events (SAEs), and Treatment-related Adverse Event (AE) | Death was a fatal event leading to permanent cessations of all vital functions of the body. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment related=having certain, probable, possible, or missing relationship to study drug. |
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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 |
|---|---|---|---|---|---|---|
| University Of Alabama At Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Childrens Hospital Of La |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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16 participants were enrolled and 9 were treated. Reasons for non-treatment: 1 withdrew consent and 6 no longer met study criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Belatacept | A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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AUC (0 - T) and AUC (0 - INF) were derived from serum concentration versus time data and measured in microgram hours per milliliter (µg*h/mL). Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to "zero" which was 0.003 micrograms per milliliter (ug/mL).
| Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57 |
| Total Body Clearance (CLT) of Belatacept | CLT was the volume of abatacept cleared by the system, normalized by baseline body weight. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to "zero" which was 0.003 micrograms per milliliter (ug/mL). CLT was measured in milliliters per hours per kilogram of body weight (mL/h/kg). | Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57 |
| Volume of Distribution at Steady-state (Vss) of Belatacept | Vss was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to "zero" which was 0.003 micrograms per milliliter (ug/mL). Vss was measured in liters per kg body weight (L/kg). | Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57 |
| Date of First Dose to 24 weeks post the last dose; approximately 26 weeks |
| Number of Participants With Positive Belatacept-induced Immunogenicity Response | Serum samples were analyzed for anti-belatacept antibodies using a validated homogenous bridging assay. The assay followed a tiered approach consistent with health authority guidance: tier 1 for screening ADA responses, tier 2 for confirming drug specificity of the ADA-positive responses, and tier 3 for titer. A neutralizing antibody assay was used to test those samples positive to the LEA29Y portion of the molecule in tier 2 and for which drug concentrations are =>1 μg/mL. Lack of immunogenicity was defined as the absence of a positive response. | Baseline/Day 1, Days 15, 29, and 57 |
| Percentage of CD86 Receptor Occupancy | Blood samples collected following the single dose belatacept infusion were assessed for CD86 receptor occupancy (CD86 RO). | 0.5 hours post dose on Day 1, Day 29 and Day 57 |
| Los Angeles |
| California |
| 90027 |
| United States |
| University Of California Los Angeles | Los Angeles | California | 90095 | United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| Childrens National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Boston Childrens Hospital | Boston | Massachusetts | 02115 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Belatacept | A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants With Death, Serious Adverse Events (SAEs), and Treatment-related Adverse Event (AE) | Death was a fatal event leading to permanent cessations of all vital functions of the body. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment related=having certain, probable, possible, or missing relationship to study drug. | All treated participants who received at least one dose of belatacept. | Posted | Number | participants | Date of First Dose to 24 weeks post the last dose; approximately 26 weeks |
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| Primary | Maximum Observed Serum Concentration (Cmax) of Belatacept | Cmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to "zero" which was 0.003 micrograms per milliliter (ug/mL). Cmax was measured in micrograms per milliliter. | Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter | Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57 |
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| Primary | Time of Maximum Observed Plasma Concentration (Tmax) of Belatacept | Tmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to "zero" which was 0.003 micrograms per milliliter (ug/mL). Tmax was measured in hours (h). | Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination. | Posted | Median | Full Range | hours | Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57 |
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| Primary | Half-Life of Elimination (T-Half) of Belatacept | T-HALF was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to "zero" which was 0.003 micrograms per milliliter (ug/mL). T-HALF was measured in hours (h). | Pharmacokinetic (PK) analysis set: all participants who received one dose of belataceptand who had at least 1 blood sample drawn for PK determination. | Posted | Mean | Standard Deviation | hours | Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57 |
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| Primary | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC (0-T)) and Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Belatacept | AUC (0 - T) and AUC (0 - INF) were derived from serum concentration versus time data and measured in microgram hours per milliliter (µg*h/mL). Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to "zero" which was 0.003 micrograms per milliliter (ug/mL). | Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram hours per milliliter | Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57 |
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| Primary | Total Body Clearance (CLT) of Belatacept | CLT was the volume of abatacept cleared by the system, normalized by baseline body weight. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to "zero" which was 0.003 micrograms per milliliter (ug/mL). CLT was measured in milliliters per hours per kilogram of body weight (mL/h/kg). | Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination. | Posted | Geometric Mean | Geometric Coefficient of Variation | milliliters per hours per kilogram | Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57 |
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| Primary | Volume of Distribution at Steady-state (Vss) of Belatacept | Vss was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to "zero" which was 0.003 micrograms per milliliter (ug/mL). Vss was measured in liters per kg body weight (L/kg). | Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters per kilogram | Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57 |
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| Secondary | Number of Participants With Positive Belatacept-induced Immunogenicity Response | Serum samples were analyzed for anti-belatacept antibodies using a validated homogenous bridging assay. The assay followed a tiered approach consistent with health authority guidance: tier 1 for screening ADA responses, tier 2 for confirming drug specificity of the ADA-positive responses, and tier 3 for titer. A neutralizing antibody assay was used to test those samples positive to the LEA29Y portion of the molecule in tier 2 and for which drug concentrations are =>1 μg/mL. Lack of immunogenicity was defined as the absence of a positive response. | All treated participants who received at least one dose of belatacept. | Posted | Number | participants | Baseline/Day 1, Days 15, 29, and 57 |
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| Secondary | Percentage of CD86 Receptor Occupancy | Blood samples collected following the single dose belatacept infusion were assessed for CD86 receptor occupancy (CD86 RO). | Pharmacodynamic analysis set: all participants who received one dose of belatacept and who had at least 1 pharmacodynamic result (CD86 RO) reported after that dose. | Posted | Mean | Standard Deviation | percent | 0.5 hours post dose on Day 1, Day 29 and Day 57 |
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SAEs were reported from the date of first dose to 24 weeks post the last dose (approximately 26 weeks); AEs were reported for the on study period from the date of first dose up to 56 days post last dose (approximately 10 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Belatacept | A single dose of 7.5 mg/kg Belatacept was given intravenously on study Day 1 over approximately 30 minutes. | 4 | 9 | 3 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
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| Unknown or Not Reported |
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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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| Title | Measurements |
|---|---|
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