Study to Assess the Efficacy and Safety of Bleselumab in... | NCT02921789

Name	Class
Kyowa Kirin Co., Ltd.	INDUSTRY

Label	Type	Description	Intervention Names
Standard of Care (SOC) Regimen	Active Comparator	Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20 milligrams (mg) administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1 gram (g) administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 milligram per kilogram per day (mg/kg/day) (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 nanogram per milliliter (ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.	Drug: Basiliximab Drug: Mycophenolate Mofetil (MMF) Drug: Tacrolimus Capsules Drug: Methylprednisone Drug: Prednisone
Bleselumab Regimen	Experimental	Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.

Name	Type	Description	Arm Group Labels	Other Names
Bleselumab	Drug	Intravenous infusion	Bleselumab Regimen	ASKP1240

Measure	Description	Time Frame
Percentage of Participants With Recurrence of Focal Segmental Glomerulosclerosis (rFSGS) or Death or Graft Loss or Lost to Follow-up Through 3 Months Post Transplant	rFSGS was defined as nephrotic range proteinuria with a protein/creatinine ratio (≥ 3.0 g/g). Death, graft loss or lost to follow-up was imputed as rFSGS.	At 3 Months post transplant

Measure	Description	Time Frame
Percentage of Participants With rFSGS or Death or Graft Loss or Lost to Follow-up Through 6 and 12 Months Post Transplant	rFSGS was defined as nephrotic range proteinuria with a protein/creatinine ratio (≥ 3.0 g/g). Death, graft loss or lost to follow-up was imputed as rFSGS.	At 6 and 12 Months post transplant

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is a recipient of a de novo kidney from a living or deceased donor and has biopsy-proven, primary FSGS (pFSGS) as a cause of end stage renal disease (ESRD) in the subject's native kidneys (initial diagnosing biopsy report is required). A subject who has biopsy-proven pFSGS as a cause of ESRD, and the subject's most current graft failure(s) is due to the recurrence of FSGS, is eligible.
Subject is anticipated to receive first oral dose of tacrolimus within 48 hours of transplant procedure.
Subject must be willing and able to comply with the study requirements including prohibited concomitant medication restrictions.
Subject agrees not to participate in another interventional study while on treatment.

Exclusion Criteria:

Subject has Induction therapy, other than study-assigned basiliximab, planned as part of initial immunosuppressive regimen.
Subject has a diagnosis of secondary FSGS (familial, virus associated, medication, etc.) or a defined genetic cause of FSGS.
Subject has previously received any organ transplant including a kidney and the most current graft failure(s) is not due to the recurrence of FSGS.
Subject will receive a kidney as part of a multi-organ transplant.
Subject will receive a dual kidney transplant from a deceased donor.
Subject will receive a kidney with an anticipated cold ischemia time (CIT) of > 30 hours.
Subject will receive a kidney that meets BOTH Extended Criteria Donor (ECD) and Donation after Cardiac Death (DCD) criteria. (A kidney that meets either ECD OR DCD criteria may be eligible for inclusion.)
Subject will receive a blood group system (A, AB, B, O, ABO) incompatible (including A2 into B or O) donor kidney.
Recipient or donor is known to be seropositive for human immuno-deficiency virus (HIV).
Subject has a current calculated panel reactive antibody (cPRA) level > 50%.
Subject has a current malignancy or a history of malignancy (within the past 5 years), except nonmetastatic basal or squamous cell carcinoma of the skin that has been treated successfully, or a renal cell carcinoma that has been treated successfully more than 2 years prior to transplantation.
Subject has significant liver disease, defined as having during the past 21 days consistently elevated aspartate aminotransferase (AST) (SGOT) and/or alanine aminotransferase (ALT) (SGPT) levels greater than 1.5 times the upper value of the normal range of the investigational site.
Subject is known to have a positive test for latent tuberculosis (TB) and has not previously received adequate anti-microbial therapy/or would require TB prophylaxis after transplant.
Subject has an uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
Subject is concurrently participating in another drug study or has received an investigational drug up to 30 days or 5 half-lives prior to transplant.
Subject is currently receiving or has received up to 8 weeks prior to transplant an immunologic biologic compound (i.e., tumor necrosis factor (TNF) inhibitors, [e.g., etanercept, adalimumab], intravenous immunoglobulin (IVIG)). A subject who has previously received a kidney organ transplant and is currently on an immunosuppression regimen that includes MMF, or any of its components, must discontinue MMF.
Subject has previously received bleselumab or participated in a clinical study with bleselumab.
Subject has a known hypersensitivity to tacrolimus, MMF, basiliximab, corticosteroids, or any of the components.
Subject has any form of substance abuse, psychiatric disorder, or a condition that could invalidate communication with the Investigator.
Subject has a clinically significant abnormal electrocardiogram (ECG) at Screening.
Subject is unlikely to comply with the visits scheduled in the protocol

Name	Affiliation	Role
Medical Director	Astellas Pharma Global Development, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Arizona		Tucson	Arizona	85724	United States
Stanford School of Medicine

PubMed Identifier	Type	Citation	Retractions
39042770	Derived	Shoji J, Goggins WC, Wellen JR, Cunningham PN, Johnston O, Chang SS, Solez K, Santos V, Larson TJ, Takeuchi M, Wang X. Efficacy and Safety of Bleselumab in Preventing the Recurrence of Primary Focal Segmental Glomerulosclerosis in Kidney Transplant Recipients: A Phase 2a, Randomized, Multicenter Study. Transplantation. 2024 Aug 1;108(8):1782-1792. doi: 10.1097/TP.0000000000004985. Epub 2024 Jul 20.

Label	URL
Link to results and other applicable study documents on the Astellas Clinical Trials website	View source

ID	Title	Description
FG000	Standard of Care (SOC) Regimen	Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20 milligrams (mg) administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1 gram (g) administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 milligram per kilogram per day (mg/kg/day) (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 nanogram per milliliter (ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 2, 2018	Dec 7, 2021

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 Recurrence of Focal Segmental Glomerulosclerosis (rFSGS) or Death or Graft Loss or Lost to Follow-up Through 3 Months Post Transplant

rFSGS was defined as nephrotic range proteinuria with a protein/creatinine ratio (≥ 3.0 g/g). Death, graft loss or lost to follow-up was imputed as rFSGS.

The Full Analysis Set (FAS) consisted of all participants who are randomized, receive at least one dose of study drug and receive a transplanted kidney. Participants who were later confirmed to have secondary FSGS were excluded from the FAS population because they were not at risk for recurrence post-transplant. Participants with available data at specified time point were included.

Posted

Number

95% Confidence Interval

Percentage of participants

At 3 Months post transplant

ID	Title	Description
OG000	SOC Regimen	Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1g administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
OG001	Bleselumab Regimen	Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.

Units	Counts
Participants	OG00032 OG00127

Title

Denominators

Categories

Title	Measurements
	OG00031.3(16.1 to 50.0) OG00118.5(6.3 to 38.1)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Fisher Exact		0.3705	Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.	Difference	-12.7			2-Sided	95	-34.5	9.0					Superiority

Secondary

Percentage of Participants With rFSGS or Death or Graft Loss or Lost to Follow-up Through 6 and 12 Months Post Transplant

rFSGS was defined as nephrotic range proteinuria with a protein/creatinine ratio (≥ 3.0 g/g). Death, graft loss or lost to follow-up was imputed as rFSGS.

FAS population with available data at specified time point.

Posted

Number

95% Confidence Interval

Percentage of participants

At 6 and 12 Months post transplant

ID	Title	Description
OG000	SOC Regimen	Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1g administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
OG001	Bleselumab Regimen	Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.

Secondary

Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Through 3, 6, and 12 Months Post Transplant

All episodes of kidney dysfunction based on clinical signs and symptoms were evaluated for possible BPAR. BPAR was confirmed if participants Banff criteria >=1.

FAS population with available data at specified time point.

Posted

Number

95% Confidence Interval

Percentage of participants

At 3, 6 and 12 Months post transplant

ID	Title	Description
OG000	SOC Regimen	Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1g administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
OG001	Bleselumab Regimen	Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.

Secondary

Percentage of Participants With Efficacy Failure Through 12 Months Post Transplant

Efficacy failure was defined as BPAR, death, graft loss or lost to follow-up through 12 months post transplant.

FAS Population with available data.

Posted

Number

95% Confidence Interval

Percentage of participants

12 Months post transplant

ID	Title	Description
OG000	SOC Regimen	Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1g administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
OG001	Bleselumab Regimen	Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.

Secondary

Percentage of Participants With Biopsy Proven rFSGS Through 3, 6 and 12 Months Post-Transplant

Percentage of participants with biopsy-proven rFSGS determined by a blinded central review of images from electron microscopy (EM) and slides for light microscopy (LM) by an independent pathologist.

FAS population with available data at specified time point.

Posted

Number

95% Confidence Interval

Percentage of participants

At 3, 6 and 12 Months post transplant

ID	Title	Description
OG000	SOC Regimen	Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1g administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
OG001	Bleselumab Regimen	Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Methaemoglobinaemia	Blood and lymphatic system disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0011 events1 affected29 at risk
Atrial flutter	Cardiac disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Intracardiac mass	Cardiac disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Nodal rhythm	Cardiac disorders	MedDRA v23.0	Systematic Assessment	EG0002 events1 affected34 at risk EG0010 events0 affected29 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Constipation	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Nausea	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Pancreatitis relapsing	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0003 events1 affected34 at risk EG0010 events0 affected29 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Vomiting	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Chest pain	General disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Non-cardiac chest pain	General disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Pyrexia	General disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Kidney transplant rejection	Immune system disorders	MedDRA v23.0	Systematic Assessment	EG0006 events5 affected34 at risk EG0012 events1 affected29 at risk
Bacteraemia	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0010 events0 affected29 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0012 events1 affected29 at risk
Diverticulitis	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Endocarditis	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Orchitis	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Peritonitis bacterial	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Polyomavirus-associated nephropathy	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Pyelonephritis	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Sepsis	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Septic shock	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0010 events0 affected29 at risk
Urinary tract infection	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Urosepsis	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0003 events2 affected34 at risk EG0010 events0 affected29 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Exposure via father	Injury, poisoning and procedural complications	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Renal lymphocele	Injury, poisoning and procedural complications	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Urine protein/creatinine ratio increased	Investigations	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0012 events2 affected29 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Essential tremor	Nervous system disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Lacunar infarction	Nervous system disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment	EG0005 events3 affected34 at risk EG0012 events2 affected29 at risk
Focal segmental glomerulosclerosis	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment	EG0003 events3 affected34 at risk EG0013 events3 affected29 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment	EG0003 events3 affected34 at risk EG0010 events0 affected29 at risk
Renal haematoma	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Renal vein thrombosis	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Subcapsular renal haematoma	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk
Hypertensive emergency	Vascular disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected29 at risk
Lymphocele	Vascular disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0011 events1 affected29 at risk
Subclavian steal syndrome	Vascular disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0010 events0 affected29 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v23.0	Systematic Assessment	EG0009 events9 affected34 at risk EG0019 events8 affected29 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0010 events0 affected29 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA v23.0	Systematic Assessment	EG0005 events5 affected34 at risk EG0012 events2 affected29 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA v23.0	Systematic Assessment	EG0008 events7 affected34 at risk EG0013 events3 affected29 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v23.0	Systematic Assessment	EG0004 events4 affected34 at risk EG0010 events0 affected29 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA v23.0	Systematic Assessment	EG0003 events2 affected34 at risk EG0011 events1 affected29 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0010 events0 affected29 at risk
Tachycardia	Cardiac disorders	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0013 events3 affected29 at risk
Vision blurred	Eye disorders	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0011 events1 affected29 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0003 events2 affected34 at risk EG0010 events0 affected29 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0005 events5 affected34 at risk EG0011 events1 affected29 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0007 events3 affected34 at risk EG0013 events3 affected29 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0003 events3 affected34 at risk EG0011 events1 affected29 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0013 events3 affected29 at risk
Constipation	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0007 events7 affected34 at risk EG0016 events6 affected29 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG00015 events11 affected34 at risk EG0019 events8 affected29 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0003 events3 affected34 at risk EG0011 events1 affected29 at risk
Flatulence	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0014 events4 affected29 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0011 events1 affected29 at risk
Nausea	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG00011 events11 affected34 at risk EG0018 events6 affected29 at risk
Vomiting	Gastrointestinal disorders	MedDRA v23.0	Systematic Assessment	EG00010 events9 affected34 at risk EG0015 events4 affected29 at risk
Chest discomfort	General disorders	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0010 events0 affected29 at risk
Fatigue	General disorders	MedDRA v23.0	Systematic Assessment	EG0005 events5 affected34 at risk EG0010 events0 affected29 at risk
Oedema peripheral	General disorders	MedDRA v23.0	Systematic Assessment	EG0005 events4 affected34 at risk EG0015 events5 affected29 at risk
Kidney transplant rejection	Immune system disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0013 events3 affected29 at risk
BK virus infection	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0003 events3 affected34 at risk EG0012 events2 affected29 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0011 events1 affected29 at risk
Epstein-Barr virus infection	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0014 events3 affected29 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0007 events4 affected34 at risk EG0010 events0 affected29 at risk
Nasopharyngitis	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0004 events4 affected34 at risk EG0011 events1 affected29 at risk
Polyomavirus viraemia	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0007 events5 affected34 at risk EG0015 events5 affected29 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0012 events2 affected29 at risk
Urinary tract infection	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0011 events1 affected29 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0010 events0 affected29 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0012 events2 affected29 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0014 events4 affected29 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA v23.0	Systematic Assessment	EG0005 events5 affected34 at risk EG0015 events5 affected29 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA v23.0	Systematic Assessment	EG00018 events14 affected34 at risk EG00111 events10 affected29 at risk
Alanine aminotransferase increased	Investigations	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0018 events6 affected29 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0015 events5 affected29 at risk
Blood creatinine increased	Investigations	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0015 events4 affected29 at risk
Histology abnormal	Investigations	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0010 events0 affected29 at risk
Transaminases increased	Investigations	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0012 events2 affected29 at risk
Weight increased	Investigations	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0012 events2 affected29 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0012 events2 affected29 at risk
Gout	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0011 events1 affected29 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG0005 events5 affected34 at risk EG0011 events1 affected29 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG0009 events8 affected34 at risk EG0015 events4 affected29 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG0008 events6 affected34 at risk EG0017 events6 affected29 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0010 events0 affected29 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0010 events0 affected29 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0010 events0 affected29 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG0003 events3 affected34 at risk EG0011 events1 affected29 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG0005 events4 affected34 at risk EG0012 events2 affected29 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG00011 events10 affected34 at risk EG0016 events6 affected29 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG00010 events9 affected34 at risk EG0016 events6 affected29 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG0009 events7 affected34 at risk EG0012 events2 affected29 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA v23.0	Systematic Assessment	EG0006 events6 affected34 at risk EG0010 events0 affected29 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Systematic Assessment	EG0002 events1 affected34 at risk EG0012 events2 affected29 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Systematic Assessment	EG0003 events3 affected34 at risk EG0010 events0 affected29 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0010 events0 affected29 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v23.0	Systematic Assessment	EG0004 events3 affected34 at risk EG0010 events0 affected29 at risk
Dizziness	Nervous system disorders	MedDRA v23.0	Systematic Assessment	EG0004 events3 affected34 at risk EG0010 events0 affected29 at risk
Headache	Nervous system disorders	MedDRA v23.0	Systematic Assessment	EG0008 events7 affected34 at risk EG0014 events4 affected29 at risk
Paraesthesia	Nervous system disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0012 events2 affected29 at risk
Tremor	Nervous system disorders	MedDRA v23.0	Systematic Assessment	EG00012 events11 affected34 at risk EG0018 events8 affected29 at risk
Insomnia	Psychiatric disorders	MedDRA v23.0	Systematic Assessment	EG0003 events3 affected34 at risk EG0013 events3 affected29 at risk
Bladder spasm	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0012 events2 affected29 at risk
Dysuria	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment	EG0003 events3 affected34 at risk EG0012 events2 affected29 at risk
Focal segmental glomerulosclerosis	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment	EG0004 events4 affected34 at risk EG0011 events1 affected29 at risk
Haematuria	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment	EG0004 events4 affected34 at risk EG0014 events4 affected29 at risk
Oliguria	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0011 events1 affected29 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0013 events3 affected29 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0012 events2 affected29 at risk
Urinary retention	Renal and urinary disorders	MedDRA v23.0	Systematic Assessment	EG0004 events4 affected34 at risk EG0010 events0 affected29 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment	EG0004 events3 affected34 at risk EG0013 events3 affected29 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment	EG0003 events2 affected34 at risk EG0011 events1 affected29 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0010 events0 affected29 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA v23.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0012 events2 affected29 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0010 events0 affected29 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA v23.0	Systematic Assessment	EG0003 events3 affected34 at risk EG0010 events0 affected29 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v23.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0013 events3 affected29 at risk
Hypertension	Vascular disorders	MedDRA v23.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0015 events5 affected29 at risk
Hypotension	Vascular disorders	MedDRA v23.0	Systematic Assessment	EG0005 events4 affected34 at risk EG0010 events0 affected29 at risk

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D005227	Fatty Acids
D008055	Lipids
D018942	Macrolides
D007783	Lactones
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Title	Description
BG000	SOC Regimen	Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1g administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
BG001	Bleselumab Regimen	Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SOC Regimen	Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1g administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.	0	34	16	34	29	34
EG001	Bleselumab Regimen	Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.	0	29	16	29	28	29

ID	Term
C586087	bleselumab
D000077552	Basiliximab
D009173	Mycophenolic Acid
D016559	Tacrolimus
D011241	Prednisone