Trial Outcomes & Findings for A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection (NCT NCT04225923)
NCT ID: NCT04225923
Last Updated: 2025-06-17
Results Overview
The proportion of patients with CMV disease (CMV syndrome or tissue-invasive CMV disease) or CMV viremia (defined as the detection of 250 IU/mL in plasma measured by PCR analysis in central laboratory or meets the local criteria for CMV viremia measured by PCR analysis or antigenemia testing) per total patients through 16 weeks from first study drug administration. The non-responders include all patients who develop CMV disease or CMV viremia and patients who discontinue from the study in the absence of CMV disease or CMV viremia.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
16 weeks
Results posted on
2025-06-17
Participant Flow
From June 2020 to August 2022, adult CMV seronegative patients who received a first kidney transplant from CMV seropositive donors were enrolled in the study at 31 sites in the United States and Japan.
Participant milestones
| Measure |
NPC-21 Low Dose
NPC-21 (6mg/kg) will be administered
NPC-21 Low dose : NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 High Dose
NPC-21 (12mg/kg) will be administered
NPC-21 High dose : NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 Placebo
Placebo (normal saline) will be administered
NPC-21 Placebo: Placebo will be administered via an approximately 60-minute intravenous infusion
|
|---|---|---|---|
|
Overall Study
STARTED
|
38
|
11
|
38
|
|
Overall Study
COMPLETED
|
33
|
10
|
33
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
5
|
Reasons for withdrawal
| Measure |
NPC-21 Low Dose
NPC-21 (6mg/kg) will be administered
NPC-21 Low dose : NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 High Dose
NPC-21 (12mg/kg) will be administered
NPC-21 High dose : NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 Placebo
Placebo (normal saline) will be administered
NPC-21 Placebo: Placebo will be administered via an approximately 60-minute intravenous infusion
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
3
|
|
Overall Study
A subject completed the study but was reported incorrectly in the report form
|
0
|
0
|
1
|
Baseline Characteristics
A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection
Baseline characteristics by cohort
| Measure |
NPC-21 Low Dose
n=38 Participants
NPC-21 (6mg/kg) will be administered
NPC-21 Low dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 High Dose
n=11 Participants
NPC-21 (12mg/kg) will be administered
NPC-21 High dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 Placebo
n=38 Participants
Placebo (normal saline) will be administered
NPC-21 Placebo: Placebo will be administered via an approximately 60-minute intravenous infusion
|
Total
n=87 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 12.45 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 15.65 • n=7 Participants
|
51.7 years
STANDARD_DEVIATION 14.04 • n=5 Participants
|
51.0 years
STANDARD_DEVIATION 13.44 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
24 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
8 participants
n=7 Participants
|
28 participants
n=5 Participants
|
64 participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
10 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
23 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: All patients who received a kidney transplant from a living or deceased donor and received at least 1 dose of study drug
The proportion of patients with CMV disease (CMV syndrome or tissue-invasive CMV disease) or CMV viremia (defined as the detection of 250 IU/mL in plasma measured by PCR analysis in central laboratory or meets the local criteria for CMV viremia measured by PCR analysis or antigenemia testing) per total patients through 16 weeks from first study drug administration. The non-responders include all patients who develop CMV disease or CMV viremia and patients who discontinue from the study in the absence of CMV disease or CMV viremia.
Outcome measures
| Measure |
NPC-21 Low Dose
n=38 Participants
NPC-21 (6mg/kg) will be administered
NPC-21 Low dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 High Dose
n=11 Participants
NPC-21 (12mg/kg) will be administered
NPC-21 High dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 Placebo
n=38 Participants
Placebo (normal saline) will be administered
NPC-21 Placebo: Placebo will be administered via an approximately 60-minute intravenous infusion
|
|---|---|---|---|
|
Incidence of CMV Disease or CMV Viremia
|
29 Participants
|
9 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 28 weeksPopulation: All patients who received a kidney transplant from a living or deceased donor and received at least 1 dose of study drug
The proportion of patients with CMV disease or CMV viremia. The non-responders include all patients who develop CMV disease or CMV viremia and patients who discontinue from the study in the absence of CMV disease or CMV viremia.
Outcome measures
| Measure |
NPC-21 Low Dose
n=38 Participants
NPC-21 (6mg/kg) will be administered
NPC-21 Low dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 High Dose
n=11 Participants
NPC-21 (12mg/kg) will be administered
NPC-21 High dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 Placebo
n=38 Participants
Placebo (normal saline) will be administered
NPC-21 Placebo: Placebo will be administered via an approximately 60-minute intravenous infusion
|
|---|---|---|---|
|
Incidence of CMV Disease or CMV Viremia
|
29 Participants
|
9 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 28 weeksPopulation: All patients who received a kidney transplant from a living or deceased donor and received at least 1 dose of study drug
The proportion of patients with CMV disease
Outcome measures
| Measure |
NPC-21 Low Dose
n=38 Participants
NPC-21 (6mg/kg) will be administered
NPC-21 Low dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 High Dose
n=11 Participants
NPC-21 (12mg/kg) will be administered
NPC-21 High dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 Placebo
n=38 Participants
Placebo (normal saline) will be administered
NPC-21 Placebo: Placebo will be administered via an approximately 60-minute intravenous infusion
|
|---|---|---|---|
|
Incidence of CMV Disease
|
2 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 28 weeksPopulation: All patients who received a kidney transplant from a living or deceased donor and received at least 1 dose of study drug
The proportion of patients with CMV viremia.
Outcome measures
| Measure |
NPC-21 Low Dose
n=38 Participants
NPC-21 (6mg/kg) will be administered
NPC-21 Low dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 High Dose
n=11 Participants
NPC-21 (12mg/kg) will be administered
NPC-21 High dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 Placebo
n=38 Participants
Placebo (normal saline) will be administered
NPC-21 Placebo: Placebo will be administered via an approximately 60-minute intravenous infusion
|
|---|---|---|---|
|
Incidence of CMV Viremia
|
22 Participants
|
8 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 28 weeksPopulation: All patients who received a kidney transplant from a living or deceased donor and received at least 1 dose of study drug
The count and proportion of patients experiencing event and censored will be summarized by treatment group.
Outcome measures
| Measure |
NPC-21 Low Dose
n=38 Participants
NPC-21 (6mg/kg) will be administered
NPC-21 Low dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 High Dose
n=11 Participants
NPC-21 (12mg/kg) will be administered
NPC-21 High dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 Placebo
n=38 Participants
Placebo (normal saline) will be administered
NPC-21 Placebo: Placebo will be administered via an approximately 60-minute intravenous infusion
|
|---|---|---|---|
|
Time to Detectable CMV Disease or CMV Viremia
|
6.1 weeks
Interval 5.0 to 9.3
|
6.3 weeks
Interval 4.1 to 8.3
|
6.3 weeks
Interval 5.1 to
Insufficient number of patients with events
|
SECONDARY outcome
Timeframe: 28 weeksPopulation: All patients who received a kidney transplant from a living or deceased donor and received at least 1 dose of study drug
The count and proportion of patients experiencing event and censored will be summarized by treatment group.
Outcome measures
| Measure |
NPC-21 Low Dose
n=38 Participants
NPC-21 (6mg/kg) will be administered
NPC-21 Low dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 High Dose
n=11 Participants
NPC-21 (12mg/kg) will be administered
NPC-21 High dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 Placebo
n=38 Participants
Placebo (normal saline) will be administered
NPC-21 Placebo: Placebo will be administered via an approximately 60-minute intravenous infusion
|
|---|---|---|---|
|
Time to Detectable CMV Disease
|
NA weeks
Insufficient number of patients with events
|
NA weeks
Insufficient number of patients with events
|
NA weeks
Insufficient number of patients with events
|
SECONDARY outcome
Timeframe: 28 weeksPopulation: All patients who received a kidney transplant from a living or deceased donor and received at least 1 dose of study drug
The count and proportion of patients experiencing event and censored will be summarized by treatment group.
Outcome measures
| Measure |
NPC-21 Low Dose
n=38 Participants
NPC-21 (6mg/kg) will be administered
NPC-21 Low dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 High Dose
n=11 Participants
NPC-21 (12mg/kg) will be administered
NPC-21 High dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 Placebo
n=38 Participants
Placebo (normal saline) will be administered
NPC-21 Placebo: Placebo will be administered via an approximately 60-minute intravenous infusion
|
|---|---|---|---|
|
Time to Detectable CMV Viremia
|
6.1 weeks
Interval 5.0 to
Insufficient number of patients with events
|
6.3 weeks
Interval 4.1 to 8.3
|
NA weeks
Interval 5.7 to
Insufficient number of patients with events
|
Adverse Events
NPC-21 Low Dose
Serious events: 17 serious events
Other events: 33 other events
Deaths: 0 deaths
NPC-21 High Dose
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
NPC-21 Placebo
Serious events: 25 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NPC-21 Low Dose
n=38 participants at risk
NPC-21 (6mg/kg) will be administered
NPC-21 Low dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 High Dose
n=11 participants at risk
NPC-21 (12mg/kg) will be administered
NPC-21 High dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 Placebo
n=38 participants at risk
Placebo (normal saline) will be administered
NPC-21 Placebo: Placebo will be administered via an approximately 60-minute intravenous infusion
|
|---|---|---|---|
|
Infections and infestations
Cytomegalovirus viraemia
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
18.2%
2/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Cytomegalovirus infection
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Cytomegalovirus syndrome
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
COVID-19
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Cellulitis
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Cytomegalovirus gastroenteritis
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Sepsis
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Urosepsis
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Cytomegalovirus oesophagitis
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Klebsiella infection
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Osteomyelitis
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Septic shock
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Staphylococcal infection
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Urinary tract infection fungal
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Wound infection
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Gastrointestinal disorders
Retroperitoneal effusion
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
13.2%
5/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Renal and urinary disorders
Haematuria
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Vascular disorders
Deep vein thrombosis
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Vascular disorders
Lymphocele
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Vascular disorders
Haematoma
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Vascular disorders
Hypertension
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Blood and lymphatic system disorders
Aplasia pure red cell
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Cardiac disorders
Tachycardia
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
General disorders
Pyrexia
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
General disorders
Impaired healing
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Immune system disorders
Transplant rejection
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Nervous system disorders
Syncope
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Nervous system disorders
Seizure
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
Other adverse events
| Measure |
NPC-21 Low Dose
n=38 participants at risk
NPC-21 (6mg/kg) will be administered
NPC-21 Low dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 High Dose
n=11 participants at risk
NPC-21 (12mg/kg) will be administered
NPC-21 High dose: NPC-21 will be administered via an approximately 60-minute intravenous infusion
|
NPC-21 Placebo
n=38 participants at risk
Placebo (normal saline) will be administered
NPC-21 Placebo: Placebo will be administered via an approximately 60-minute intravenous infusion
|
|---|---|---|---|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Cytomegalovirus infection
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
10.5%
4/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Urinary tract infection
|
15.8%
6/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
27.3%
3/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
15.8%
6/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.2%
5/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
18.2%
2/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
15.8%
6/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.5%
4/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
10.5%
4/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
13.2%
5/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
18.2%
2/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.9%
11/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
27.3%
3/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
39.5%
15/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Gastrointestinal disorders
Nausea
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
26.3%
10/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Gastrointestinal disorders
Stomatitis
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Gastrointestinal disorders
Vomiting
|
13.2%
5/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
10.5%
4/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
General disorders
Asthenia
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
General disorders
Chills
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
General disorders
Fatigue
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
18.2%
2/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
21.1%
8/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
General disorders
Oedema peripheral
|
18.4%
7/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
10.5%
4/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
General disorders
Pyrexia
|
10.5%
4/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
General disorders
Peripheral swelling
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
50.0%
19/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
63.6%
7/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
31.6%
12/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Infections and infestations
Polyomavirus viraemia
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Injury, poisoning and procedural complications
Scrotal injury
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Investigations
Amylase increased
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Investigations
Blood creatinine increased
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
15.8%
6/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Investigations
Lipase increased
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Investigations
Weight decreased
|
10.5%
4/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
10.5%
4/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Investigations
White blood cell count decreased
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Investigations
Urine output decreased
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Investigations
Donor specific antibody present
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.5%
4/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
10.5%
4/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.2%
5/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
18.2%
2/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
13.2%
5/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
10.5%
4/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
13.2%
5/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Musculoskeletal and connective tissue disorders
Osteodystrophy
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Nervous system disorders
Dizziness
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
18.4%
7/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Nervous system disorders
Headache
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
18.4%
7/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Nervous system disorders
Tremor
|
15.8%
6/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
18.2%
2/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
15.8%
6/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
18.2%
2/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Psychiatric disorders
Depression
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Psychiatric disorders
Insomnia
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Renal and urinary disorders
Dysuria
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Renal and urinary disorders
Nocturia
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Renal and urinary disorders
Perinephric collection
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
10.5%
4/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
13.2%
5/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
10.5%
4/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
9.1%
1/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Vascular disorders
Hypertension
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Vascular disorders
Hypotension
|
5.3%
2/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
10.5%
4/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
|
Vascular disorders
Orthostatic hypotension
|
2.6%
1/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
0.00%
0/11 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
7.9%
3/38 • 28 weeks
Non-serious and serious Treatment Emergent Adverse Events were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER