Trial Outcomes & Findings for Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization (NCT NCT01399593)
NCT ID: NCT01399593
Last Updated: 2017-10-03
Results Overview
The primary efficacy variable was a binary outcome variable where patients meeting the composite endpoint of the occurrence of 1) biopsy-proven acute AMR, 2) graft loss, 3) patient death, or 4) loss to follow-up definition at Week 9 post-transplantation were considered treatment failures and all others were considered treatment successes.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
9 weeks post-transplantation
Results posted on
2017-10-03
Participant Flow
Recruitment period lasted from Nov 2011 to Mar 2014. Forty-one sites in Australia, the European Union, and North America participated in this study.
Written consent was provided prior to performing any study-required assessments (N = 275). Patients who passed screening (N = 137) underwent desensitization therapy according to local transplant center practice prior to transplantation. A total of 104 patients were randomized; of these, 102 were transplanted and received eculizumab or SOC.
Participant milestones
| Measure |
Eculizumab
Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9).
|
Standard of Care
Patients received standard of care (SOC) prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
48
|
49
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Eculizumab
Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9).
|
Standard of Care
Patients received standard of care (SOC) prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Transplantectomy
|
0
|
1
|
Baseline Characteristics
Data unavailable for 4 subjects.
Baseline characteristics by cohort
| Measure |
Eculizumab
n=51 Participants
Patients in the eculizumab treatment group were to receive eculizumab for 9 weeks according to the following dosing regimen:
Eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously.
|
Standard of Care (SOC)
n=51 Participants
Patients in the standard of care (SOC) treatment group received prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
In utero
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Age, Customized
Preterm newborn - gestational age < 37 wk
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Age, Customized
Adults (18-64 years)
|
47 Participants
n=51 Participants
|
49 Participants
n=51 Participants
|
96 Participants
n=102 Participants
|
|
Age, Customized
From 65 to 84 years
|
4 Participants
n=51 Participants
|
2 Participants
n=51 Participants
|
6 Participants
n=102 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=51 Participants
|
30 Participants
n=51 Participants
|
67 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=51 Participants
|
21 Participants
n=51 Participants
|
35 Participants
n=102 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=51 Participants
|
3 Participants
n=51 Participants
|
5 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=51 Participants
|
6 Participants
n=51 Participants
|
12 Participants
n=102 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=51 Participants
|
36 Participants
n=51 Participants
|
73 Participants
n=102 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=51 Participants
|
6 Participants
n=51 Participants
|
12 Participants
n=102 Participants
|
|
Region of Enrollment
Australia
|
4 Participants
n=51 Participants
|
1 Participants
n=51 Participants
|
5 Participants
n=102 Participants
|
|
Region of Enrollment
France
|
3 Participants
n=51 Participants
|
7 Participants
n=51 Participants
|
10 Participants
n=102 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=51 Participants
|
1 Participants
n=51 Participants
|
2 Participants
n=102 Participants
|
|
Region of Enrollment
Italy
|
2 Participants
n=51 Participants
|
4 Participants
n=51 Participants
|
6 Participants
n=102 Participants
|
|
Region of Enrollment
Netherlands
|
0 Participants
n=51 Participants
|
3 Participants
n=51 Participants
|
3 Participants
n=102 Participants
|
|
Region of Enrollment
Norway
|
1 Participants
n=51 Participants
|
1 Participants
n=51 Participants
|
2 Participants
n=102 Participants
|
|
Region of Enrollment
Spain
|
3 Participants
n=51 Participants
|
4 Participants
n=51 Participants
|
7 Participants
n=102 Participants
|
|
Region of Enrollment
Sweden
|
1 Participants
n=51 Participants
|
4 Participants
n=51 Participants
|
5 Participants
n=102 Participants
|
|
Region of Enrollment
United Kingdom
|
10 Participants
n=51 Participants
|
5 Participants
n=51 Participants
|
15 Participants
n=102 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=51 Participants
|
21 Participants
n=51 Participants
|
47 Participants
n=102 Participants
|
|
Total Donor-Specific Antibodies (DSA)
|
15394.7 mean fluorescence intensity (MFI)
STANDARD_DEVIATION 14163.78 • n=50 Participants • Data unavailable for 4 subjects.
|
17469.8 mean fluorescence intensity (MFI)
STANDARD_DEVIATION 12573.44 • n=48 Participants • Data unavailable for 4 subjects.
|
16411.1 mean fluorescence intensity (MFI)
STANDARD_DEVIATION 13380.16 • n=98 Participants • Data unavailable for 4 subjects.
|
|
Highest Single Donor-Specific Antibodies (DSA)
|
8135 mean fluorescence intensity (MFI)
STANDARD_DEVIATION 4048.08 • n=50 Participants • Data unavailable for 4 subjects.
|
8740.7 mean fluorescence intensity (MFI)
STANDARD_DEVIATION 4289.97 • n=48 Participants • Data unavailable for 4 subjects.
|
8431.7 mean fluorescence intensity (MFI)
STANDARD_DEVIATION 4157.87 • n=98 Participants • Data unavailable for 4 subjects.
|
PRIMARY outcome
Timeframe: 9 weeks post-transplantationPopulation: Full analysis set, defined as patients who were randomized, received a living donor kidney transplant, and were treated (either with eculizumab or SOC), based on randomized treatment groups.
The primary efficacy variable was a binary outcome variable where patients meeting the composite endpoint of the occurrence of 1) biopsy-proven acute AMR, 2) graft loss, 3) patient death, or 4) loss to follow-up definition at Week 9 post-transplantation were considered treatment failures and all others were considered treatment successes.
Outcome measures
| Measure |
Eculizumab
n=51 Participants
Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously.
|
Standard of Care
n=51 Participants
Patients in the standard of care (SOC) treatment group received prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
|
|---|---|---|
|
Treatment Failure Rate
|
5 Participants
|
7 Participants
|
Adverse Events
Eculizumab
Serious events: 43 serious events
Other events: 51 other events
Deaths: 1 deaths
Standard of Care
Serious events: 48 serious events
Other events: 51 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Eculizumab
n=51 participants at risk
Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously.
|
Standard of Care
n=51 participants at risk
Patients received standard of care (SOC) prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Investigations
Anti-glomerular basement membrane antibody
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Investigations
Antibody test positive
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Investigations
Blood creatinine increased
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Investigations
Drug level increased
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
15.7%
8/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Diverticulum
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Large intestine perforation
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Mallory-Weiss Syndrome
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
General disorders
Chest pain
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
General disorders
Hypothermia
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
General disorders
Impaired healing
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
General disorders
Influenza like illness
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
General disorders
Oedema peripheral
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
General disorders
Systemic inflammatory response syndrome
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Immune system disorders
Kidney transplant rejection
|
43.1%
22/51 • Adverse events were collected throughout the 3-year study period.
|
54.9%
28/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Abdominal sepsis
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Arteriovenous fistula site infection
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
BK virus infection
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Bacteraemia
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Bacterial sepsis
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Fluid overload
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Bronchitis
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Cellulitis
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Cytomegalovirus infection
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Device related sepsis
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Endocarditis bacterial
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Escherichia bacteraemia
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Escherichia pyelonephritis
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Escherichia sepsis
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Escherichia urinary tract infection
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
11.8%
6/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Gastroenteritis cryptosporidial
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Gastroenteritis norovirus
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Gastroenteritis viral
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Giardiasis
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Haemophilus infection
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Infection
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Klebsiella sepsis
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Meningitis cryptococcal
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Metapneumovirus infection
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dermatofibrosarcoma protuberans
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Nervous system disorders
Headache
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Nervous system disorders
Migraine
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Nervous system disorders
Seizure
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Nervous system disorders
Spinal claudication
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Psychiatric disorders
Depression
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Glomerulonephritis
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Haematuria
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Hydronephrosis
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Otitis media
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Pneumonia
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Pneumonia cryptococcal
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Pneumonia fungal
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Postoperative wound infection
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Pseudomonal sepsis
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Pyelonephritis
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Renal abscess
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Sepsis
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Urinary tract infection
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
13.7%
7/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Urinary tract infection bacterial
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Urosepsis
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Wound infection
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Ateriovenous fistula site haemorrhage
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Delayed graft function
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Injury
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Eye disorders
Eye pain
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Blood and lymphatic system disorders
Microangiopathic haemolytic anaemia
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Cardiac disorders
Cardiac perforation
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Nephrectasia
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Proteinuria
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Renal cyst
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Ureteric dilatation
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Urethral stenosis
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Social circumstances
Convalescent
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Surgical and medical procedures
Nephrostomy
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Vascular disorders
Deep vein thrombosis
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Vascular disorders
Hypertension
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Vascular disorders
Hypotension
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Vascular disorders
Hypovolaemic shock
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Vascular disorders
Lymphocele
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
|
Vascular disorders
Superior vena cava occlusion
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
Other adverse events
| Measure |
Eculizumab
n=51 participants at risk
Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously.
|
Standard of Care
n=51 participants at risk
Patients received standard of care (SOC) prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
31.4%
16/51 • Adverse events were collected throughout the 3-year study period.
|
54.9%
28/51 • Adverse events were collected throughout the 3-year study period.
|
|
Blood and lymphatic system disorders
Hypofibrinogenaemia
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
31.4%
16/51 • Adverse events were collected throughout the 3-year study period.
|
45.1%
23/51 • Adverse events were collected throughout the 3-year study period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
23.5%
12/51 • Adverse events were collected throughout the 3-year study period.
|
|
Cardiac disorders
Tachycardia
|
11.8%
6/51 • Adverse events were collected throughout the 3-year study period.
|
19.6%
10/51 • Adverse events were collected throughout the 3-year study period.
|
|
Eye disorders
Vision blurred
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
9/51 • Adverse events were collected throughout the 3-year study period.
|
25.5%
13/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Constipation
|
27.5%
14/51 • Adverse events were collected throughout the 3-year study period.
|
29.4%
15/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Diarrhoea
|
43.1%
22/51 • Adverse events were collected throughout the 3-year study period.
|
52.9%
27/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Flatulence
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Nausea
|
51.0%
26/51 • Adverse events were collected throughout the 3-year study period.
|
37.3%
19/51 • Adverse events were collected throughout the 3-year study period.
|
|
Gastrointestinal disorders
Vomiting
|
25.5%
13/51 • Adverse events were collected throughout the 3-year study period.
|
13.7%
7/51 • Adverse events were collected throughout the 3-year study period.
|
|
General disorders
Asthenia
|
19.6%
10/51 • Adverse events were collected throughout the 3-year study period.
|
19.6%
10/51 • Adverse events were collected throughout the 3-year study period.
|
|
General disorders
Chest pain
|
13.7%
7/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
General disorders
Chills
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
|
General disorders
Influenza like illness
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
General disorders
Malaise
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
General disorders
Oedema
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
|
General disorders
Oedema peripheral
|
29.4%
15/51 • Adverse events were collected throughout the 3-year study period.
|
41.2%
21/51 • Adverse events were collected throughout the 3-year study period.
|
|
General disorders
Pain
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
13.7%
7/51 • Adverse events were collected throughout the 3-year study period.
|
|
General disorders
Pyrexia
|
23.5%
12/51 • Adverse events were collected throughout the 3-year study period.
|
31.4%
16/51 • Adverse events were collected throughout the 3-year study period.
|
|
Immune system disorders
Drug hypersensitivity
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Immune system disorders
Kidney transplant rejection
|
37.3%
19/51 • Adverse events were collected throughout the 3-year study period.
|
33.3%
17/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
BK virus infection
|
23.5%
12/51 • Adverse events were collected throughout the 3-year study period.
|
17.6%
9/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Bronchitis
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Cellulitis
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Cytomegalovirus infection
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
11.8%
6/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Escherichia urinary tract infection
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Gastroenteritis
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
15.7%
8/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Oral candidiasis
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Respiratory tract infection
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.5%
13/51 • Adverse events were collected throughout the 3-year study period.
|
21.6%
11/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Urinary tract infection
|
54.9%
28/51 • Adverse events were collected throughout the 3-year study period.
|
35.3%
18/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Urinary tract infection bacterial
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
15.7%
8/51 • Adverse events were collected throughout the 3-year study period.
|
11.8%
6/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Perinephric collection
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
13.7%
7/51 • Adverse events were collected throughout the 3-year study period.
|
15.7%
8/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
11.8%
6/51 • Adverse events were collected throughout the 3-year study period.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
|
Investigations
Antibody test positive
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Investigations
Blood creatinine increased
|
17.6%
9/51 • Adverse events were collected throughout the 3-year study period.
|
23.5%
12/51 • Adverse events were collected throughout the 3-year study period.
|
|
Investigations
Liver function test abnormal
|
13.7%
7/51 • Adverse events were collected throughout the 3-year study period.
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
|
Investigations
Weight decreased
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Investigations
Weight increased
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Acidosis
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.8%
6/51 • Adverse events were collected throughout the 3-year study period.
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
17.6%
9/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Fluid overload
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
11.8%
6/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
27.5%
14/51 • Adverse events were collected throughout the 3-year study period.
|
31.4%
16/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
19.6%
10/51 • Adverse events were collected throughout the 3-year study period.
|
29.4%
15/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
27.5%
14/51 • Adverse events were collected throughout the 3-year study period.
|
25.5%
13/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
21.6%
11/51 • Adverse events were collected throughout the 3-year study period.
|
19.6%
10/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.5%
13/51 • Adverse events were collected throughout the 3-year study period.
|
25.5%
13/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.8%
6/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
31.4%
16/51 • Adverse events were collected throughout the 3-year study period.
|
23.5%
12/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
23.5%
12/51 • Adverse events were collected throughout the 3-year study period.
|
19.6%
10/51 • Adverse events were collected throughout the 3-year study period.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
15.7%
8/51 • Adverse events were collected throughout the 3-year study period.
|
11.8%
6/51 • Adverse events were collected throughout the 3-year study period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
6/51 • Adverse events were collected throughout the 3-year study period.
|
19.6%
10/51 • Adverse events were collected throughout the 3-year study period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
21.6%
11/51 • Adverse events were collected throughout the 3-year study period.
|
15.7%
8/51 • Adverse events were collected throughout the 3-year study period.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Nervous system disorders
Dizziness
|
13.7%
7/51 • Adverse events were collected throughout the 3-year study period.
|
11.8%
6/51 • Adverse events were collected throughout the 3-year study period.
|
|
Nervous system disorders
Headache
|
27.5%
14/51 • Adverse events were collected throughout the 3-year study period.
|
17.6%
9/51 • Adverse events were collected throughout the 3-year study period.
|
|
Nervous system disorders
Migraine
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Nervous system disorders
Tremor
|
27.5%
14/51 • Adverse events were collected throughout the 3-year study period.
|
27.5%
14/51 • Adverse events were collected throughout the 3-year study period.
|
|
Psychiatric disorders
Anxiety
|
15.7%
8/51 • Adverse events were collected throughout the 3-year study period.
|
11.8%
6/51 • Adverse events were collected throughout the 3-year study period.
|
|
Psychiatric disorders
Depression
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Psychiatric disorders
Insomnia
|
13.7%
7/51 • Adverse events were collected throughout the 3-year study period.
|
21.6%
11/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Bladder spasm
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Dysuria
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Haematuria
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
19.6%
10/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Nocturia
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Oliguria
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
11.8%
6/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Polyuria
|
11.8%
6/51 • Adverse events were collected throughout the 3-year study period.
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Proteinuria
|
17.6%
9/51 • Adverse events were collected throughout the 3-year study period.
|
11.8%
6/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Renal impairment
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
|
Renal and urinary disorders
Urinary retention
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
11.8%
6/51 • Adverse events were collected throughout the 3-year study period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
11.8%
6/51 • Adverse events were collected throughout the 3-year study period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
17.6%
9/51 • Adverse events were collected throughout the 3-year study period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.6%
9/51 • Adverse events were collected throughout the 3-year study period.
|
17.6%
9/51 • Adverse events were collected throughout the 3-year study period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.8%
5/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Vascular disorders
Deep vein thrombosis
|
7.8%
4/51 • Adverse events were collected throughout the 3-year study period.
|
2.0%
1/51 • Adverse events were collected throughout the 3-year study period.
|
|
Vascular disorders
Haematoma
|
3.9%
2/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
|
Vascular disorders
Hypertension
|
25.5%
13/51 • Adverse events were collected throughout the 3-year study period.
|
29.4%
15/51 • Adverse events were collected throughout the 3-year study period.
|
|
Vascular disorders
Hypotension
|
15.7%
8/51 • Adverse events were collected throughout the 3-year study period.
|
21.6%
11/51 • Adverse events were collected throughout the 3-year study period.
|
|
Vascular disorders
Lymphocele
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
5.9%
3/51 • Adverse events were collected throughout the 3-year study period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place