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The purpose of this study is to evaluate the efficacy, safety and tolerability of dual costimulation blockade with VIB4920 in combination of belatacept in adult male or female recipients of a renal allograft from a deceased, living unrelated or human leukocyte antigen (HLA) non-identical living related donor.
Study with completed results acquired from Horizon in 2024.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belatacept+VIB4920 | Experimental | Participants will be admitted to the transplant center for the administration of VIB4920 and belatacept (with Thymoglobulin and corticosteroids) and will be discharged on Day 3/4 at the discretion of the investigator. Participants will return to the study center to receive study drugs (VIB4920 and /or belatacept) weekly for 2 visits, then every 2 weeks for 5 visits, and then monthly for 9 visits for safety monitoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belatacept | Drug | Protocol versions 1 through 4: Belatacept 10 mg/kg by intravenous (IV) infusion on post-op Day 1, repeated on post-op Day 3 or 4 (timing is at investigator's discretion), and at the end of Weeks 2, 4, 8 and 12; then 5 mg/kg IV every 4 weeks from Week 16 to Week 48. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Week 24 | Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Weeks 12 and 48 | Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. |
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Inclusion Criteria:
Recipients of a first renal transplant from standard criteria deceased, living unrelated or HLA non-identical living related donor.
Recipients who are at low immunologic risk:
Recipients with up to date vaccination as per local immunization schedules.
Male and female participants who agree to follow protocol defined contraceptive methods.
Exclusion Criteria:
Participants receiving an allograft from an ABO-incompatible donor.
Participants treated with systemic immunosuppressive drug therapy for more than a total of 2 weeks within 24 weeks prior to informed consent form signature.
Participants who have undergone lymphodepleting therapy.
Participants with medical history of confirmed venous thromboembolism, arterial thrombosis, coagulopathy or known platelet disorders.
Participants with risk factors for venous thromboembolism or arterial thrombosis, prothrombotic status.
Participants requiring treatment with antithrombotic drugs (clopidogrel, prasugrel, warfarin, others).
Participants requiring long-term systemic anticoagulation after transplantation, which would interfere with obtaining biopsies.
Participants with any contraindication to kidney biopsy.
Cytomegalovirus (CMV)-seronegative recipients of a CMV-seropositive donor kidney, or unknown CMV serostatus.
Epstein-Barr virus (EBV)-seronegative or with unknown EBV serostatus.
Receipt of live (attenuated) vaccine within the 4 weeks before screening.
Participants with high potential of graft loss due to recurrence of underlying kidney disease.
Prior solid organ transplant or potential to require a concurrent organ or cell transplant.
Previous treatment with belatacept and cluster of differentiation 40 (CD40) or anti-CD40L agents.
Use of B cell depleting therapy, non-depleting B cell directed therapy e.g., belimumab or abatacept within 1 year prior to enrolment.
At screening blood tests any of the following:
Participants with severe systemic infections, current or within the 2 weeks prior to transplant surgery.
Positive test for chronic hepatitis B infection at screening or within the last 12 months.
Positive test for hepatitis C virus antibody at screening or within the last 12 months.
Positive test for human immunodeficiency viruses antibody at screening or within the last 12 months.
History of or active tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening, unless previously treated for latent tuberculosis.
History of cancer, except as follows:
Lactating or pregnant females.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Medical Center of USC | Los Angeles | California | 90033 | United States | ||
| University of California, San Francisco |
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A total of 25 participants underwent transplant surgery (enrolled); two of these participants were not treated, and are not included in any analysis. A total of 3 participants were enrolled prior to protocol version 3.
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| ID | Title | Description |
|---|---|---|
| FG000 | Belatacept+VIB4920 | Belatacept (protocol versions [v]1-4): 10 mg/kg by intravenous (IV) infusion on post-op Day 1, repeated on post-op Day 3 or 4, and at the end of Weeks 2, 4, 8, 12; then 5 mg/kg IV every 4 weeks from Week 16 to Week 48. VIB4920 (protocol v1-2): 1500 mg by IV infusion on post-op Days 1 and 14, and at the end of Weeks 4, 6, 8, 10; then 1500 mg every 4 weeks from Week 12 to Week 48. Protocol v3-4: 1500 mg by IV infusion on post-op Days 1, repeated on post-op Day 3 or 4, Week 2, and at the end of Weeks 4, 6, 8, 10; then 1500 mg every 4 weeks from Week 12 to Week 48. Thymoglobulin (protocol v1-2): 3.0 mg/kg by IV infusion prior to reperfusion of the allograft on the day of transplantation surgery (Day 0). Protocol v3-4: 1.5 mg/kg by IV infusion prior to reperfusion of the allograft on the day of transplantation surgery (Day 0), prior to VIB4920+belatacept infusion on post-op Day 1, on post-op Day 2, and prior to VIB4920+belatacept infusion on post-op Day 3 or 4. Methylprednisolone (protocol v1-2): IV infusion (500, 250, 125, 60 mg on Days 0, 1, 2, 3, respectively); oral administration of prednisone 30 mg per day on Days 4, 5, 6. Protocol v3-4: IV infusion (500, 250, 125, 60 mg on Days 0, 1, 2, 3, respectively); oral administration of prednisone 30 mg per day on Days 4, 5, 6 and 7. Participants may be tapered to ≤ 20 mg per day on Day 8, to ≤ 10 mg per day on Day 15, and to ≤ 5 mg per day on Day 22. Discontinuation of prednisone following the post-op Day 28 visit. |
| 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 | Jul 23, 2021 | Jun 16, 2023 |
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|
| VIB4920 | Drug | Protocol versions 1 and 2: VIB4920 1500 mg by IV infusion on post-op Days 1 and 14, and at the end of Weeks 4, 6, 8 and 10; then 1500 mg every 4 weeks from Week 12 to Week 48. Protocol versions 3 and 4: VIB4920 1500 mg by IV infusion on post-op Days 1, repeated on post-op Day 3 or 4 (timing is at investigator's discretion), Week 2, and at the end of Weeks 4, 6, 8, and 10; then 1500 mg every 4 weeks from Week 12 to Week 48. |
|
| Thymoglobulin | Drug | Protocol versions 1 and 2: Thymoglobulin 3.0 mg/kg by intravenous (IV) infusion prior to reperfusion of the allograft on the day of transplantation surgery (Day 0) (1 dose). Protocol versions 3 and 4: Thymoglobulin 1.5 mg/kg by intravenous infusion prior to reperfusion of the allograft on the day of transplantation surgery (Day 0), prior to VIB4920+belatacept infusion on post-op Day 1, on post-op Day 2, and prior to VIB4920+belatacept infusion on post-op Day 3 or 4. |
|
| Methylprednisolone | Drug | Protocol versions 1 and 2: Methylprednisolone by IV infusion (500, 250, 125 and 60 mg on Days 0, 1, 2 and 3, respectively) followed by oral administration of prednisone 30 mg per day on Days 4, 5, and 6. Protocol versions 3 and 4: Methylprednisolone by IV infusion (500, 250, 125 and 60 mg on Days 0, 1, 2 and 3, respectively) followed by oral administration of prednisone 30 mg per day on Days 4, 5, 6 and 7. Participants may be tapered to at least 20 mg per day on Day 8, to at least 10 mg per day on Day 15, and to at least 5 mg per day on Day 22. Discontinuation of prednisone following the post-op Day 28 visit. |
|
| Weeks 12 and 48 |
| Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR), Graft Loss, Death or Loss to Follow-up (LTFU) | Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. | Week 12, 24, 48 |
| Percentage of Participants With Antibody-Mediated Rejection | The diagnosis of antibody-mediated rejection was based on Banff criteria 2017 - a set of standardized guidelines used by pathologists and clinicians to diagnose and classify rejection based on specific features observed in biopsy samples from the transplanted organ, such as the presence of certain types of immune cells, inflammation, and injury patterns. | Week 12, 24, 48 |
| Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) | Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. | Week 12, 24, 48 |
| Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) | Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. | Week 12, 24, 48 |
| Percentage of Participants With Treated Acute Rejections | Acute rejections, per clinical judgement of the investigator followed by confirmatory biopsy, were treated with bolus methylprednisolone (other corticosteroids were acceptable at an equivalent dose) according to local practice. | Week 12, 24, 48 |
| Percentage of Participants With De Novo Donor-specific Antibodies (dnDSA) | Serum samples were collected for de novo donor-specific antibodies (dnDSA) using solid phase (bead-based) assays. | Week 12, 24, 48 |
| San Francisco |
| California |
| 94143 |
| United States |
| Duke University School of Medicine | Durham | North Carolina | 27710 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
|
| Enrolled Prior to Protocol V3.0 |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Belatacept+VIB4920 | Belatacept (protocol versions [v]1-4): 10 mg/kg by intravenous (IV) infusion on post-op Day 1, repeated on post-op Day 3 or 4, and at the end of Weeks 2, 4, 8, 12; then 5 mg/kg IV every 4 weeks from Week 16 to Week 48. VIB4920 (protocol v1-2): 1500 mg by IV infusion on post-op Days 1 and 14, and at the end of Weeks 4, 6, 8, 10; then 1500 mg every 4 weeks from Week 12 to Week 48. Protocol v3-4: 1500 mg by IV infusion on post-op Days 1, repeated on post-op Day 3 or 4, Week 2, and at the end of Weeks 4, 6, 8, 10; then 1500 mg every 4 weeks from Week 12 to Week 48. Thymoglobulin (protocol v1-2): 3.0 mg/kg by IV infusion prior to reperfusion of the allograft on the day of transplantation surgery (Day 0). Protocol v3-4: 1.5 mg/kg by IV infusion prior to reperfusion of the allograft on the day of transplantation surgery (Day 0), prior to VIB4920+belatacept infusion on post-op Day 1, on post-op Day 2, and prior to VIB4920+belatacept infusion on post-op Day 3 or 4. Methylprednisolone (protocol v1-2): IV infusion (500, 250, 125, 60 mg on Days 0, 1, 2, 3, respectively); oral administration of prednisone 30 mg per day on Days 4, 5, 6. Protocol v3-4: IV infusion (500, 250, 125, 60 mg on Days 0, 1, 2, 3, respectively); oral administration of prednisone 30 mg per day on Days 4, 5, 6 and 7. Participants may be tapered to ≤ 20 mg per day on Day 8, to ≤ 10 mg per day on Day 15, and to ≤ 5 mg per day on Day 22. Discontinuation of prednisone following the post-op Day 28 visit. |
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Week 24 | Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. | Efficacy Evaluable Set: All participants who received the revised regimen of Thymoglobulin and steroids, and any dose of investigational product (IP). Participants enrolled in protocol v3 - 4 were included in the analysis. | Posted | Number | 80% Confidence Interval | percentage of participants | Week 24 |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Weeks 12 and 48 | Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. | Efficacy Evaluable Set: All participants who received the revised regimen of Thymoglobulin and steroids, and any dose of IP. Participants enrolled in protocol v3 - 4 were included in the analysis. | Posted | Number | 80% Confidence Interval | percentage of participants | Weeks 12 and 48 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR), Graft Loss, Death or Loss to Follow-up (LTFU) | Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. | Efficacy Evaluable Set: All participants who received the revised regimen of Thymoglobulin and steroids, and any dose of IP. Participants enrolled in protocol v3 - 4 were included in the analysis. | Posted | Number | 80% Confidence Interval | percentage of participants | Week 12, 24, 48 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Antibody-Mediated Rejection | The diagnosis of antibody-mediated rejection was based on Banff criteria 2017 - a set of standardized guidelines used by pathologists and clinicians to diagnose and classify rejection based on specific features observed in biopsy samples from the transplanted organ, such as the presence of certain types of immune cells, inflammation, and injury patterns. | Efficacy Evaluable Set: All participants who received the revised regimen of Thymoglobulin and steroids, and any dose of IP. Participants enrolled in protocol v3 - 4 were included in the analysis. | Posted | Number | 80% Confidence Interval | percentage of participants | Week 12, 24, 48 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) | Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. | Efficacy Evaluable Set: All participants who received the revised regimen of Thymoglobulin and steroids, and any dose of IP. Participants enrolled in protocol v3 - 4 were included in the analysis. | Posted | Number | 80% Confidence Interval | percentage of participants | Week 12, 24, 48 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) | Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. | Efficacy Evaluable Set: All participants who received the revised regimen of Thymoglobulin and steroids, and any dose of IP. Participants enrolled in protocol v3 - 4 were included in the analysis. | Posted | Number | 80% Confidence Interval | percentage of participants | Week 12, 24, 48 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treated Acute Rejections | Acute rejections, per clinical judgement of the investigator followed by confirmatory biopsy, were treated with bolus methylprednisolone (other corticosteroids were acceptable at an equivalent dose) according to local practice. | Efficacy Evaluable Set: All participants who received the revised regimen of Thymoglobulin and steroids, and any dose of IP. Participants enrolled in protocol v3 - 4 were included in the analysis. | Posted | Number | 80% Confidence Interval | percentage of participants | Week 12, 24, 48 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With De Novo Donor-specific Antibodies (dnDSA) | Serum samples were collected for de novo donor-specific antibodies (dnDSA) using solid phase (bead-based) assays. | Not Posted | Week 12, 24, 48 | Participants |
All-Cause Mortality: From written informed consent signature (Day -28 to -1) and the end of the safety follow-up 60 weeks (up to 64 weeks) Adverse Events: From first dose of study drug until the end of treatment + 12 weeks (up to 60 weeks)
As it is in our pre-specified analysis, all safety data was based on safety analysis set, i.e., all subjects who received any dose of IP.
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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+VIB4920 | Belatacept (protocol versions [v]1-4): 10 mg/kg by intravenous (IV) infusion on post-op Day 1, repeated on post-op Day 3 or 4, and at the end of Weeks 2, 4, 8, 12; then 5 mg/kg IV every 4 weeks from Week 16 to Week 48. VIB4920 (protocol v1-2): 1500 mg by IV infusion on post-op Days 1 and 14, and at the end of Weeks 4, 6, 8, 10; then 1500 mg every 4 weeks from Week 12 to Week 48. Protocol v3-4: 1500 mg by IV infusion on post-op Days 1, repeated on post-op Day 3 or 4, Week 2, and at the end of Weeks 4, 6, 8, 10; then 1500 mg every 4 weeks from Week 12 to Week 48. Thymoglobulin (protocol v1-2): 3.0 mg/kg by IV infusion prior to reperfusion of the allograft on the day of transplantation surgery (Day 0). Protocol v3-4: 1.5 mg/kg by IV infusion prior to reperfusion of the allograft on the day of transplantation surgery (Day 0), prior to VIB4920+belatacept infusion on post-op Day 1, on post-op Day 2, and prior to VIB4920+belatacept infusion on post-op Day 3 or 4. Methylprednisolone (protocol v1-2): IV infusion (500, 250, 125, 60 mg on Days 0, 1, 2, 3, respectively); oral administration of prednisone 30 mg per day on Days 4, 5, 6. Protocol v3-4: IV infusion (500, 250, 125, 60 mg on Days 0, 1, 2, 3, respectively); oral administration of prednisone 30 mg per day on Days 4, 5, 6 and 7. Participants may be tapered to ≤ 20 mg per day on Day 8, to ≤ 10 mg per day on Day 15, and to ≤ 5 mg per day on Day 22. Discontinuation of prednisone following the post-op Day 28 visit. | 0 | 23 | 10 | 23 | 20 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
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| Kidney transplant rejection | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Diabetic foot infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Post procedural urine leak | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Cytomegalovirus test positive | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Depression suicidal | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
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| Subcapsular renal haematoma | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
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| Ureteric stenosis | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
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| BK virus infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
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Horizon requests that any investigator/institution that plans on presenting/publishing results provide written notification of their request 60 days prior to their presentation/publication. Horizon requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Horizon needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Todd Wilson, DO | Horizon Therapeutics USA, Inc. | 866-479-6742 | clinicaltrials@horizontherapeutics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 26, 2020 | Jun 16, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069594 | Abatacept |
| C512542 | thymoglobulin |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| 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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