Trial Outcomes & Findings for Combined Kidney and Bone Marrow Transplantation to Prevent Kidney Transplant Rejection (NCT NCT00801632)

Last Updated: 2015-11-10

Results Overview

A participant was considered a success if they were off immunosuppressive therapy for 104 consecutive weeks leading up to study week 208 (48 months post-transplant) or study termination, whichever occurred first.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

48 months post-transplant

Results posted on

2015-11-10

Participant Flow

Participants with end-stage renal disease and no evidence of prior sensitization were enrolled between December 2008 and September 2009.

Participant milestones

Participant milestones
Measure	MEDI-507 Recipients received a conditioning treatment that started with rituximab (375 mg/m\^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	MEDI-507 Recipients received a conditioning treatment that started with rituximab (375 mg/m\^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Overall Study Re-transplant	1

Baseline Characteristics

Combined Kidney and Bone Marrow Transplantation to Prevent Kidney Transplant Rejection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MEDI-507 n=5 Participants Recipients received a conditioning treatment that started with rituximab (375 mg/m\^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	32.8 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
Baseline Creatinine Level	1.9 mg/dL STANDARD_DEVIATION 1.2 • n=5 Participants

PRIMARY outcome

Timeframe: 48 months post-transplant

Population: Intent-to-treat

Outcome measures

Outcome measures
Measure	MEDI-507 n=5 Participants Recipients received a conditioning treatment that started with rituximab (375 mg/m\^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks	3 participants

SECONDARY outcome

Timeframe: Transplantation until study completion or participant termination (up to five years)

Population: Intent-to-treat

The percentage of participants who experience an acute rejection. Acute rejection is defined as a biopsy with findings of Banff score of grade IA or higher. The Banff classification is as follows: grade IA is \>25% of parenchyma affected and foci of moderate tubulitis; Grade IB is \>25% of parenchyma affected and foci of severe tubulitis; Grade IIA is mild to moderate intimal arteritis; Grade IIB is severe intimal arteritis comprising \>25% of the luminal area; Grade III is "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.

Outcome measures

Outcome measures
Measure	MEDI-507 n=5 Participants Recipients received a conditioning treatment that started with rituximab (375 mg/m\^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Percentage of Participants Experiencing Acute Rejection	40 Percentage of Participants Interval 5.3 to 85.3

SECONDARY outcome

Timeframe: Transplantation until study completion or participant termination (up to five years)

Population: Intent-to-treat

Change in renal function as seen in serum creatinine values from baseline until study completion or participant termination. Baseline is defined as the lowest serum creatinine collected during stabilization period or in the four weeks following the end of the stabilization period. The stabilization period is defined as four consecutive creatinine values close in value (not differing more than 0.3 mg/dL). Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys.

Outcome measures

Outcome measures
Measure	MEDI-507 n=5 Participants Recipients received a conditioning treatment that started with rituximab (375 mg/m\^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Change in Renal Function Baseline Serum Creatinine	1.9 mg/dL Standard Deviation 1.2
Change in Renal Function Study Termination/Completion	3.2 mg/dL Standard Deviation 2.7
Change in Renal Function Change from Baseline	1.2 mg/dL Standard Deviation 1.9

SECONDARY outcome

Timeframe: Transplantation until week 156

Population: Participants who were followed at least three years after transplantation or experienced graft loss prior to week 156

The percentage of participants with graft survival from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded. Graft survival is defined as the time to week 156 or graft loss. Graft loss is defined as the day on which a graft is deemed irreversibly nonfunctional and dialysis is begun, a transplantectomy is performed, or the participant is re-transplanted, whichever comes first. Six consecutive weeks of dialysis are required for the diagnosis of graft loss, though the date of graft loss will be defined as the date of first dialysis.

Outcome measures

Outcome measures
Measure	MEDI-507 n=5 Participants Recipients received a conditioning treatment that started with rituximab (375 mg/m\^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Percentage of Participants With Graft Survival Through 156 Weeks	80 Percentage of Participants Interval 28.4 to 99.5

SECONDARY outcome

Timeframe: Transplantation until week 156

Population: Participants who were followed at least three years after transplantation or experienced death prior to week 156

The percentage of participants who survived from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded.

Outcome measures

Outcome measures
Measure	MEDI-507 n=4 Participants Recipients received a conditioning treatment that started with rituximab (375 mg/m\^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Percentage of Participants Surviving Through 156 Weeks	100 Percentage of Participants Interval 39.8 to 100.0

SECONDARY outcome

Timeframe: Transplantation until study completion or participant termination (participants followed up to five years)

Population: Intent-to-treat

Time (in days) until neutrophil recovery following transplant. Neutrophil recovery is defined as an absolute neutrophil count (ANC) \> 500/mm\^3 at three consecutive assessments on different days post-transplant. Time to recovery is time from transplantation until the first assessment date used to confirm the recovery.

Outcome measures

Outcome measures
Measure	MEDI-507 n=5 Participants Recipients received a conditioning treatment that started with rituximab (375 mg/m\^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Time to Neutrophil Recovery Following Transplant	14.0 days Standard Deviation 4.1

SECONDARY outcome

Timeframe: Transplantation until study completion or participant termination (participants followed up to five years)

Population: Intent-to-treat

Time (in days) until platelet recovery following transplant. Platelet recovery is defined as a platelet count \>20,000 /mm\^3 and where no transfusion is required. Time to recovery is time from transplantation until platelet value recovers.

Outcome measures

Outcome measures
Measure	MEDI-507 n=5 Participants Recipients received a conditioning treatment that started with rituximab (375 mg/m\^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Time to Platelet Recovery Following Transplant	1.0 days Standard Deviation 0.0

SECONDARY outcome

Timeframe: Transplantation until study completion or participant termination (participants followed up to five years)

Population: Intent-to-treat

Clinically significant invasive or resistant opportunistic infections include cytomegalovirus, herpes zoster, and candida.

Outcome measures

Outcome measures
Measure	MEDI-507 n=5 Participants Recipients received a conditioning treatment that started with rituximab (375 mg/m\^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Percentage of Participants Experiencing a Clinically Significant Invasive or Resistant Opportunistic Infection	0 Percentage of Participants Interval 0.0 to 52.2

Adverse Events

MEDI-507

Serious events: 5 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MEDI-507 n=5 participants at risk Recipients received a conditioning treatment that started with rituximab (375 mg/m\^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Blood and lymphatic system disorders Anaemia	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Blood and lymphatic system disorders Thrombotic microangiopathy	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Cardiac disorders Atrial fibrillation	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Gastrointestinal disorders Stomatitis	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Immune system disorders Engraftment syndrome	100.0% 5/5 • Number of events 5 • Transplantation until study completion or participant termination (up to five years)
Immune system disorders Transplant rejection	40.0% 2/5 • Number of events 2 • Transplantation until study completion or participant termination (up to five years)
Infections and infestations Gastroenteritis	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Infections and infestations Urinary tract infection	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Infections and infestations Viral infection	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Injury, poisoning and procedural complications Post procedural haemorrhage	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Investigations Blood creatinine increased	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Vascular disorders Haematoma	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Vascular disorders Thrombosis	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)

Other adverse events

Other adverse events
Measure	MEDI-507 n=5 participants at risk Recipients received a conditioning treatment that started with rituximab (375 mg/m\^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
Blood and lymphatic system disorders Anaemia	40.0% 2/5 • Number of events 2 • Transplantation until study completion or participant termination (up to five years)
Blood and lymphatic system disorders Neutropenia	20.0% 1/5 • Number of events 6 • Transplantation until study completion or participant termination (up to five years)
Blood and lymphatic system disorders Thrombocytopenia	60.0% 3/5 • Number of events 3 • Transplantation until study completion or participant termination (up to five years)
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Gastrointestinal disorders Gastritis	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Gastrointestinal disorders Nausea	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Gastrointestinal disorders Vomiting	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
General disorders Catheter related complication	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
General disorders Pyrexia	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Infections and infestations Catheter site infection	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Infections and infestations Clostridium difficile colitis	40.0% 2/5 • Number of events 2 • Transplantation until study completion or participant termination (up to five years)
Infections and infestations Urinary tract infection	60.0% 3/5 • Number of events 4 • Transplantation until study completion or participant termination (up to five years)
Injury, poisoning and procedural complications Drug toxicity	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Injury, poisoning and procedural complications Limb injury	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Investigations Alanine aminotransferase increased	40.0% 2/5 • Number of events 2 • Transplantation until study completion or participant termination (up to five years)
Investigations Weight increased	40.0% 2/5 • Number of events 2 • Transplantation until study completion or participant termination (up to five years)
Metabolism and nutrition disorders Hyperglycaemia	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Metabolism and nutrition disorders Hyperkalaemia	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Metabolism and nutrition disorders Hyponatraemia	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)
Metabolism and nutrition disorders Hypophosphataemia	40.0% 2/5 • Number of events 2 • Transplantation until study completion or participant termination (up to five years)
Renal and urinary disorders Proteinuria	80.0% 4/5 • Number of events 4 • Transplantation until study completion or participant termination (up to five years)
Renal and urinary disorders Renal failure acute	20.0% 1/5 • Number of events 1 • Transplantation until study completion or participant termination (up to five years)

Additional Information

Director, Clinical Research Program

DAIT/NIAID

Phone: 301-594-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place