Trial Outcomes & Findings for Treg Modulation With CD28 and IL-6 Receptor Antagonists (NCT NCT04066114)

Last Updated: 2024-10-09

Results Overview

Acute T-cell mediated rejection was defined using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to 1A were determined to have met the endpoint. Severity is graded as 1A, 1B, 2A, 2B, or 3, with 1A being the mildest form of cellular rejection and 3 being the most severe form of cellular rejection. Antibody mediated rejection was defined as diffusely positive staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury. Clinical rejection occurring prior to 6 months, defined as treated rejection without biopsy confirmation was included as acute rejection with respect to the endpoint.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

24 participants

Primary outcome timeframe

6 months post-transplantation

Results posted on

2024-10-09

Participant Flow

15 adult, kidney transplant candidates were enrolled across 4 US sites between December 2019 and March 2022. Of the 15 enrolled transplant candidates, 8 participants initiated treatment. The 7 participants who did not initiate study treatment were terminated because they did not meet eligibility criteria. Additionally, 9 donors were consented and enrolled across 3 US sites between December 2019 and August 2021.

Potential participants signed informed consent and enrolled before undergoing any study procedures. Screening criteria were evaluated to determine study eligibility. Participants were enrolled prior to transplantation. Living donors were asked to consent (at which point they were considered enrolled) for a single blood draw and minimal medical information.

Participant milestones

Participant milestones
Measure	Transplanted, Received Lulizumab The participants underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) and methylprednisone and were initially maintained on tocilizumab and prednisone. Lulizumab pegol (BMS-931699) was administered on the day after transplantation and weekly until 3 months; after which it was replaced with belatacept every 4 weeks. MMF was started on the day after transplant. Everolimus was added 14 days post-transplant. MMF was discontinued once everolimus level was within therapeutic range. Tocilizumab was discontinued at 6 months post-transplant. Participants were then maintained on belatacept, everolimus, and prednisone.	Screen Failure Participants who failed screening.	Enrolled Living Donor Living donors of the prospective transplant recipient were consented and enrolled into the study.
Overall Study STARTED	8	7	9
Overall Study COMPLETED	6	0	9
Overall Study NOT COMPLETED	2	7	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Transplanted, Received Lulizumab The participants underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) and methylprednisone and were initially maintained on tocilizumab and prednisone. Lulizumab pegol (BMS-931699) was administered on the day after transplantation and weekly until 3 months; after which it was replaced with belatacept every 4 weeks. MMF was started on the day after transplant. Everolimus was added 14 days post-transplant. MMF was discontinued once everolimus level was within therapeutic range. Tocilizumab was discontinued at 6 months post-transplant. Participants were then maintained on belatacept, everolimus, and prednisone.	Screen Failure Participants who failed screening.
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	1	0
Overall Study Did Not Meet Eligibility Criteria	0	7

Baseline Characteristics

Treg Modulation With CD28 and IL-6 Receptor Antagonists

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transplanted, Received Lulizumab n=8 Participants The participants underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) and methylprednisone and were initially maintained on tocilizumab and prednisone. Lulizumab pegol (BMS-931699) was administered on the day after transplantation and weekly until 3 months; after which it was replaced with belatacept every 4 weeks. MMF was started on the day after transplant. Everolimus was added 14 days post-transplant. MMF was discontinued once everolimus level was within therapeutic range. Tocilizumab was discontinued at 6 months post-transplant. Participants were then maintained on belatacept, everolimus, and prednisone.	Enrolled Living Donor n=9 Participants Living donors of the prospective transplant recipient were consented and enrolled into the study.	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	50.1 years STANDARD_DEVIATION 11.32 • n=5 Participants	42.7 years STANDARD_DEVIATION 10.26 • n=7 Participants	46.2 years STANDARD_DEVIATION 11.11 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months post-transplantation

Population: Intent-to-treat population, which includes the same subjects as the safety population, subset to participants who remained in the study in the 6 months following transplantation.

Outcome measures

Outcome measures
Measure	Transplanted, Received Lulizumab n=6 Participants The participants underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) and methylprednisone and were initially maintained on tocilizumab and prednisone. Lulizumab pegol (BMS-931699) was administered on the day after transplantation and weekly until 3 months; after which it was replaced with belatacept every 4 weeks. MMF was started on the day after transplant. Everolimus was added 14 days post-transplant. MMF was discontinued once everolimus level was within therapeutic range. Tocilizumab was discontinued at 6 months post-transplant. Participants were then maintained on belatacept, everolimus, and prednisone.
The Proportion of Participants Who Remain Free of Biopsy-proven Acute T-cell Mediated or Antibody-mediated Rejection (as Defined by Banff Criteria) at 6 Months Post-transplantation.	0.500 Proportion of participants Interval 0.118 to 0.882

SECONDARY outcome

Timeframe: 12 months post-transplantation

Population: Intent-to-treat population, which includes the same subjects as the safety population, subset to participants who remained in the study in the 12 months following transplantation.

Acute T-cell mediated rejection was defined using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to 1A were determined to have met the endpoint. Severity is graded as 1A, 1B, 2A, 2B, or 3, with 1A being the mildest form of cellular rejection and 3 being the most severe form of cellular rejection. Antibody mediated rejection was defined as diffusely positive staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury. Clinical rejection occurring prior to 12 months, defined as treated rejection without biopsy confirmation were included as acute rejection with respect to the endpoint.

Outcome measures

Outcome measures
Measure	Transplanted, Received Lulizumab n=6 Participants The participants underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) and methylprednisone and were initially maintained on tocilizumab and prednisone. Lulizumab pegol (BMS-931699) was administered on the day after transplantation and weekly until 3 months; after which it was replaced with belatacept every 4 weeks. MMF was started on the day after transplant. Everolimus was added 14 days post-transplant. MMF was discontinued once everolimus level was within therapeutic range. Tocilizumab was discontinued at 6 months post-transplant. Participants were then maintained on belatacept, everolimus, and prednisone.
The Proportion of Participants Who Remain Free of Biopsy-proven Acute T-cell Mediated or Antibody-mediated Rejection (as Defined by Banff Criteria) at 12 Months Post-transplantation.	0.500 Proportion of participants Interval 0.118 to 0.882

Adverse Events

'Transplanted/Received Lulizumab'

Serious events: 8 serious events

Other events: 5 other events

Deaths: 0 deaths

'Enrolled Living Donor'

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	'Transplanted/Received Lulizumab' n=8 participants at risk 'The participants underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) and methylprednisone and were initially maintained on tocilizumab and prednisone. Lulizumab pegol (BMS-931699) was administered on the day after transplantation and weekly until 3 months; after which it was replaced with belatacept every 4 weeks. MMF was started on the day after transplant. Everolimus was added 14 days post-transplant. MMF was discontinued once everolimus level was within therapeutic range. Tocilizumab was discontinued at 6 months post-transplant. Participants were then maintained on belatacept, everolimus, and prednisone.'	'Enrolled Living Donor' n=9 participants at risk 'Living donors of the prospective transplant recipient were consented and enrolled into the study.'
Blood and lymphatic system disorders Neutropenia	25.0% 2/8 • Number of events 2 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Blood and lymphatic system disorders Thrombocytopenia	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Gastrointestinal disorders Abdominal pain	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Gastrointestinal disorders Aphthous ulcer	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Gastrointestinal disorders Mouth ulceration	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Infections and infestations Oesophageal candidiasis	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Infections and infestations Oral candidiasis	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Infections and infestations Urinary tract candidiasis	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Infections and infestations Urinary tract infection	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Investigations Klebsiella test positive	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Metabolism and nutrition disorders Hypervolaemia	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.

Additional Information

Director, Clinical Research Operations Program

DAIT/NIAID

Phone: 301-594-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	'Transplanted/Received Lulizumab' n=8 participants at risk 'The participants underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) and methylprednisone and were initially maintained on tocilizumab and prednisone. Lulizumab pegol (BMS-931699) was administered on the day after transplantation and weekly until 3 months; after which it was replaced with belatacept every 4 weeks. MMF was started on the day after transplant. Everolimus was added 14 days post-transplant. MMF was discontinued once everolimus level was within therapeutic range. Tocilizumab was discontinued at 6 months post-transplant. Participants were then maintained on belatacept, everolimus, and prednisone.'	'Enrolled Living Donor' n=9 participants at risk 'Living donors of the prospective transplant recipient were consented and enrolled into the study.'
Blood and lymphatic system disorders Febrile neutropenia	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Blood and lymphatic system disorders Neutropenia	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Gastrointestinal disorders Intra-abdominal fluid collection	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Gastrointestinal disorders Oesophagitis	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Hepatobiliary disorders Cholecystitis acute	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Immune system disorders Transplant rejection	37.5% 3/8 • Number of events 3 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Infections and infestations Abdominal abscess	12.5% 1/8 • Number of events 2 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Infections and infestations COVID-19	37.5% 3/8 • Number of events 3 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Infections and infestations Clostridium difficile colitis	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Infections and infestations Pneumonia	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Infections and infestations Pyelonephritis	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Infections and infestations Sepsis	25.0% 2/8 • Number of events 2 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Infections and infestations Urinary tract infection	37.5% 3/8 • Number of events 4 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Injury, poisoning and procedural complications Procedural hypotension	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Metabolism and nutrition disorders Hyperglycaemia	12.5% 1/8 • Number of events 2 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Renal and urinary disorders Acute kidney injury	37.5% 3/8 • Number of events 5 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Renal and urinary disorders Renal tubular necrosis	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.
Renal and urinary disorders Subcapsular renal haematoma	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.	0.00% 0/9 • Adverse events were collected from the time of first study mandated procedure until a subject completed study participation (either 24 months post-transplant or 12 months post-transplant, if entered into reduced follow-up) or until 30 days after they prematurely withdrew (without withdrawing consent) or was withdrawn from the study.