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Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization

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ClinicalTrials.gov Identifier: NCT01399593
Recruitment Status : Terminated (Did not achieve statistical significance for primary endpoint)
First Posted : July 22, 2011
Results First Posted : April 19, 2017
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Antibody Mediated Rejection
Intervention Drug: Eculizumab
Enrollment 102
Recruitment Details Recruitment period lasted from Nov 2011 to Mar 2014. Forty-one sites in Australia, the European Union, and North America participated in this study.
Pre-assignment Details 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.
Arm/Group Title Eculizumab Standard of Care
Hide Arm/Group Description 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). 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.
Period Title: Overall Study
Started 51 51
Completed 48 49
Not Completed 3 2
Reason Not Completed
Physician Decision             1             0
Adverse Event             1             0
Death             1             1
Transplantectomy             0             1
Arm/Group Title Eculizumab Standard of Care (SOC) Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 51 51 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
In utero Number Analyzed 51 participants 51 participants 102 participants
0
   0.0%
0
   0.0%
0
   0.0%
Preterm newborn - gestational age < 37 wk Number Analyzed 51 participants 51 participants 102 participants
0
   0.0%
0
   0.0%
0
   0.0%
Newborns (0-27 days) Number Analyzed 51 participants 51 participants 102 participants
0
   0.0%
0
   0.0%
0
   0.0%
Infants and toddlers (28 days-23 months) Number Analyzed 51 participants 51 participants 102 participants
0
   0.0%
0
   0.0%
0
   0.0%
Children (2-11 years) Number Analyzed 51 participants 51 participants 102 participants
0
   0.0%
0
   0.0%
0
   0.0%
Adolescents (12-17 years) Number Analyzed 51 participants 51 participants 102 participants
0
   0.0%
0
   0.0%
0
   0.0%
Adults (18-64 years) Number Analyzed 51 participants 51 participants 102 participants
47
  92.2%
49
  96.1%
96
  94.1%
From 65 to 84 years Number Analyzed 51 participants 51 participants 102 participants
4
   7.8%
2
   3.9%
6
   5.9%
85 years and over Number Analyzed 51 participants 51 participants 102 participants
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 102 participants
Female
37
  72.5%
30
  58.8%
67
  65.7%
Male
14
  27.5%
21
  41.2%
35
  34.3%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 102 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   3.9%
3
   5.9%
5
   4.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  11.8%
6
  11.8%
12
  11.8%
White
37
  72.5%
36
  70.6%
73
  71.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
6
  11.8%
6
  11.8%
12
  11.8%
[1]
Measure Description: Patients appearing under "Unknown or Not Reported" were categorized as "Other" by the investigator.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Australia Number Analyzed 51 participants 51 participants 102 participants
4
   7.8%
1
   2.0%
5
   4.9%
France Number Analyzed 51 participants 51 participants 102 participants
3
   5.9%
7
  13.7%
10
   9.8%
Germany Number Analyzed 51 participants 51 participants 102 participants
1
   2.0%
1
   2.0%
2
   2.0%
Italy Number Analyzed 51 participants 51 participants 102 participants
2
   3.9%
4
   7.8%
6
   5.9%
Netherlands Number Analyzed 51 participants 51 participants 102 participants
0
   0.0%
3
   5.9%
3
   2.9%
Norway Number Analyzed 51 participants 51 participants 102 participants
1
   2.0%
1
   2.0%
2
   2.0%
Spain Number Analyzed 51 participants 51 participants 102 participants
3
   5.9%
4
   7.8%
7
   6.9%
Sweden Number Analyzed 51 participants 51 participants 102 participants
1
   2.0%
4
   7.8%
5
   4.9%
United Kingdom Number Analyzed 51 participants 51 participants 102 participants
10
  19.6%
5
   9.8%
15
  14.7%
United States Number Analyzed 51 participants 51 participants 102 participants
26
  51.0%
21
  41.2%
47
  46.1%
Total Donor-Specific Antibodies (DSA)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Mean fluorescence intensity (MFI)
Number Analyzed 50 participants 48 participants 98 participants
15394.7  (14163.78) 17469.8  (12573.44) 16411.1  (13380.16)
[1]
Measure Description: The presence of donor-specific antibodies (DSA) indicates that a patient has become sensitized, i.e., has preformed antibodies against donor specific human leukocyte antigens (HLAs). A higher DSA level indicates greater sensitization and greater risk of antibody-mediated rejection (AMR).
[2]
Measure Analysis Population Description: Data unavailable for 4 subjects.
Highest Single Donor-Specific Antibodies (DSA)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Mean fluorescence intensity (MFI)
Number Analyzed 50 participants 48 participants 98 participants
8135  (4048.08) 8740.7  (4289.97) 8431.7  (4157.87)
[1]
Measure Description: The presence of donor-specific antibodies (DSA) indicates that a patient has become sensitized, i.e., has preformed antibodies against donor specific human leukocyte antigens (HLAs). A higher DSA level indicates greater sensitization and greater risk of antibody-mediated rejection (AMR).
[2]
Measure Analysis Population Description: Data unavailable for 4 subjects.
1.Primary Outcome
Title Treatment Failure Rate
Hide Description 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.
Time Frame 9 weeks post-transplantation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Eculizumab Standard of Care
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 51 51
Measure Type: Count of Participants
Unit of Measure: Participants
5
   9.8%
7
  13.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eculizumab, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion difference
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-23.9 to 16.3
Estimation Comments [Not Specified]
Time Frame Adverse events were collected throughout the 3-year study period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eculizumab Standard of Care
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Eculizumab Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   1/51 (1.96%)   1/51 (1.96%) 
Show Serious Adverse Events Hide Serious Adverse Events
Eculizumab Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   43/51 (84.31%)   48/51 (94.12%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/51 (1.96%)  2/51 (3.92%) 
Coagulopathy * 1  0/51 (0.00%)  1/51 (1.96%) 
Haemolytic uraemic syndrome * 1  0/51 (0.00%)  1/51 (1.96%) 
Leukopenia * 1  1/51 (1.96%)  0/51 (0.00%) 
Microangiopathic haemolytic anaemia * 1  0/51 (0.00%)  1/51 (1.96%) 
Neutropenia * 1  1/51 (1.96%)  0/51 (0.00%) 
Normochromic normocytic anaemia * 1  0/51 (0.00%)  1/51 (1.96%) 
Pancytopenia * 1  0/51 (0.00%)  1/51 (1.96%) 
Cardiac disorders     
Acute myocardial infarction * 1  1/51 (1.96%)  1/51 (1.96%) 
Atrial fibrillation * 1  1/51 (1.96%)  0/51 (0.00%) 
Cardiac arrest * 1  0/51 (0.00%)  1/51 (1.96%) 
Cardiac failure * 1  0/51 (0.00%)  2/51 (3.92%) 
Cardiac failure congestive * 1  0/51 (0.00%)  1/51 (1.96%) 
Cardiac perforation * 1  1/51 (1.96%)  0/51 (0.00%) 
Myocardial ischaemia * 1  0/51 (0.00%)  1/51 (1.96%) 
Sinus node dysfunction * 1  0/51 (0.00%)  1/51 (1.96%) 
Eye disorders     
Eye pain * 1  0/51 (0.00%)  1/51 (1.96%) 
Gastrointestinal disorders     
Abdominal hernia * 1  0/51 (0.00%)  1/51 (1.96%) 
Abdominal pain * 1  1/51 (1.96%)  0/51 (0.00%) 
Abdominal pain upper * 1  0/51 (0.00%)  1/51 (1.96%) 
Abdominal wall haematoma * 1  0/51 (0.00%)  1/51 (1.96%) 
Colitis ulcerative * 1  1/51 (1.96%)  0/51 (0.00%) 
Diarrhoea * 1  3/51 (5.88%)  8/51 (15.69%) 
Diverticulum * 1  1/51 (1.96%)  0/51 (0.00%) 
Gastrointestinal haemorrhage * 1  0/51 (0.00%)  1/51 (1.96%) 
Haemorrhoids * 1  0/51 (0.00%)  1/51 (1.96%) 
Large intestine perforation * 1  1/51 (1.96%)  0/51 (0.00%) 
Mallory-Weiss Syndrome * 1  1/51 (1.96%)  0/51 (0.00%) 
Nausea * 1  0/51 (0.00%)  1/51 (1.96%) 
Pancreatitis acute * 1  1/51 (1.96%)  2/51 (3.92%) 
Pancreatitis relapsing * 1  0/51 (0.00%)  1/51 (1.96%) 
Small intestinal haemorrhage * 1  0/51 (0.00%)  1/51 (1.96%) 
Subileus * 1  0/51 (0.00%)  1/51 (1.96%) 
Upper gastrointestinal haemorrhage * 1  1/51 (1.96%)  0/51 (0.00%) 
Vomiting * 1  1/51 (1.96%)  1/51 (1.96%) 
General disorders     
Chest pain * 1  2/51 (3.92%)  0/51 (0.00%) 
Hypothermia * 1  0/51 (0.00%)  1/51 (1.96%) 
Impaired healing * 1  1/51 (1.96%)  0/51 (0.00%) 
Influenza like illness * 1  1/51 (1.96%)  0/51 (0.00%) 
Oedema peripheral * 1  2/51 (3.92%)  0/51 (0.00%) 
Systemic inflammatory response syndrome * 1  1/51 (1.96%)  0/51 (0.00%) 
Hepatobiliary disorders     
Cholecystitis chronic * 1  0/51 (0.00%)  1/51 (1.96%) 
Immune system disorders     
Drug hypersensitivity * 1  0/51 (0.00%)  1/51 (1.96%) 
Kidney transplant rejection * 1  22/51 (43.14%)  28/51 (54.90%) 
Infections and infestations     
Abdominal sepsis * 1 [1]  1/51 (1.96%)  0/51 (0.00%) 
Arteriovenous fistula site infection * 1  1/51 (1.96%)  0/51 (0.00%) 
BK virus infection * 1  1/51 (1.96%)  0/51 (0.00%) 
Bacteraemia * 1  1/51 (1.96%)  0/51 (0.00%) 
Bacterial sepsis * 1 [1]  1/51 (1.96%)  0/51 (0.00%) 
Bronchiolitis * 1  0/51 (0.00%)  1/51 (1.96%) 
Bronchitis * 1  2/51 (3.92%)  3/51 (5.88%) 
Bronchopulmonary aspergillosis * 1  0/51 (0.00%)  1/51 (1.96%) 
Cellulitis * 1  2/51 (3.92%)  2/51 (3.92%) 
Cytomegalovirus infection * 1  1/51 (1.96%)  0/51 (0.00%) 
Cytomegalovirus viraemia * 1  0/51 (0.00%)  1/51 (1.96%) 
Device related sepsis * 1  1/51 (1.96%)  1/51 (1.96%) 
Endocarditis bacterial * 1  1/51 (1.96%)  0/51 (0.00%) 
Escherichia bacteraemia * 1  1/51 (1.96%)  0/51 (0.00%) 
Escherichia pyelonephritis * 1  1/51 (1.96%)  0/51 (0.00%) 
Escherichia sepsis * 1  1/51 (1.96%)  1/51 (1.96%) 
Escherichia urinary tract infection * 1  4/51 (7.84%)  6/51 (11.76%) 
Gastroenteritis * 1  0/51 (0.00%)  4/51 (7.84%) 
Gastroenteritis cryptosporidial * 1  0/51 (0.00%)  1/51 (1.96%) 
Gastroenteritis norovirus * 1  1/51 (1.96%)  1/51 (1.96%) 
Gastroenteritis viral * 1  1/51 (1.96%)  2/51 (3.92%) 
Giardiasis * 1  1/51 (1.96%)  0/51 (0.00%) 
Haemophilus infection * 1  1/51 (1.96%)  0/51 (0.00%) 
Infection * 1  1/51 (1.96%)  0/51 (0.00%) 
Klebsiella sepsis * 1  1/51 (1.96%)  1/51 (1.96%) 
Lower respiratory tract infection * 1  2/51 (3.92%)  0/51 (0.00%) 
Meningitis cryptococcal * 1  1/51 (1.96%)  0/51 (0.00%) 
Metapneumovirus infection * 1  1/51 (1.96%)  0/51 (0.00%) 
Otitis media * 1  1/51 (1.96%)  0/51 (0.00%) 
Pneumonia * 1  3/51 (5.88%)  4/51 (7.84%) 
Pneumonia cryptococcal * 1  1/51 (1.96%)  0/51 (0.00%) 
Pneumonia fungal * 1  1/51 (1.96%)  0/51 (0.00%) 
Pneumonia viral * 1  0/51 (0.00%)  1/51 (1.96%) 
Postoperative wound infection * 1  1/51 (1.96%)  0/51 (0.00%) 
Pseudomonal sepsis * 1  1/51 (1.96%)  0/51 (0.00%) 
Pyelonephritis * 1  4/51 (7.84%)  2/51 (3.92%) 
Renal abscess * 1  1/51 (1.96%)  0/51 (0.00%) 
Sepsis * 1  1/51 (1.96%)  1/51 (1.96%) 
Upper respiratory tract infection * 1  0/51 (0.00%)  1/51 (1.96%) 
Urinary tract infection * 1  2/51 (3.92%)  7/51 (13.73%) 
Urinary tract infection bacterial * 1  2/51 (3.92%)  1/51 (1.96%) 
Urinary tract infection enterococcal * 1  1/51 (1.96%)  2/51 (3.92%) 
Urinary tract infection pseudomonal * 1  1/51 (1.96%)  1/51 (1.96%) 
Urinary tract infection staphylococcal * 1  1/51 (1.96%)  0/51 (0.00%) 
Urosepsis * 1  4/51 (7.84%)  2/51 (3.92%) 
Wound infection * 1  0/51 (0.00%)  1/51 (1.96%) 
Injury, poisoning and procedural complications     
Arteriovenous fistula thrombosis * 1  1/51 (1.96%)  0/51 (0.00%) 
Ateriovenous fistula site haemorrhage * 1  1/51 (1.96%)  0/51 (0.00%) 
Complications of transplanted kidney * 1  0/51 (0.00%)  1/51 (1.96%) 
Delayed graft function * 1  2/51 (3.92%)  1/51 (1.96%) 
Graft thrombosis * 1  0/51 (0.00%)  1/51 (1.96%) 
Incisional hernia * 1  2/51 (3.92%)  1/51 (1.96%) 
Injury * 1  1/51 (1.96%)  0/51 (0.00%) 
Post procedural haematoma * 1  0/51 (0.00%)  1/51 (1.96%) 
Post procedural haematuria * 1  0/51 (0.00%)  2/51 (3.92%) 
Post procedural haemorrhage * 1  1/51 (1.96%)  3/51 (5.88%) 
Procedural pain * 1  0/51 (0.00%)  1/51 (1.96%) 
Tendon rupture * 1  1/51 (1.96%)  0/51 (0.00%) 
Toxicity to various agents * 1  0/51 (0.00%)  1/51 (1.96%) 
Upper limb fracture * 1  1/51 (1.96%)  0/51 (0.00%) 
Vascular graft complication * 1  1/51 (1.96%)  0/51 (0.00%) 
Wound dehiscence * 1  0/51 (0.00%)  2/51 (3.92%) 
Investigations     
Anti-glomerular basement membrane antibody * 1  1/51 (1.96%)  0/51 (0.00%) 
Antibody test positive * 1  1/51 (1.96%)  0/51 (0.00%) 
Blood creatinine increased * 1  3/51 (5.88%)  1/51 (1.96%) 
Drug level increased * 1 [2]  1/51 (1.96%)  0/51 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  0/51 (0.00%)  1/51 (1.96%) 
Diabetes mellitus inadequate control * 1  0/51 (0.00%)  1/51 (1.96%) 
Fluid overload * 1  1/51 (1.96%)  0/51 (0.00%) 
Gout * 1  0/51 (0.00%)  1/51 (1.96%) 
Hyperglycaemia * 1  1/51 (1.96%)  0/51 (0.00%) 
Hyperkalaemia * 1  0/51 (0.00%)  1/51 (1.96%) 
Hypoglycaemia * 1  0/51 (0.00%)  1/51 (1.96%) 
Hypokalaemia * 1  1/51 (1.96%)  0/51 (0.00%) 
Metabolic acidosis * 1  0/51 (0.00%)  1/51 (1.96%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/51 (0.00%)  1/51 (1.96%) 
Musculoskeletal pain * 1  1/51 (1.96%)  0/51 (0.00%) 
Myalgia * 1  0/51 (0.00%)  1/51 (1.96%) 
Myopathy * 1  1/51 (1.96%)  0/51 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Dermatofibrosarcoma protuberans * 1  0/51 (0.00%)  1/51 (1.96%) 
Post transplant lymphoproliferative disorder * 1  1/51 (1.96%)  0/51 (0.00%) 
Tonsil cancer * 1  0/51 (0.00%)  1/51 (1.96%) 
Nervous system disorders     
Cerebellar haemorrhage * 1  1/51 (1.96%)  0/51 (0.00%) 
Headache * 1  0/51 (0.00%)  2/51 (3.92%) 
Migraine * 1  2/51 (3.92%)  0/51 (0.00%) 
Seizure * 1  0/51 (0.00%)  1/51 (1.96%) 
Spinal claudication * 1  1/51 (1.96%)  0/51 (0.00%) 
Psychiatric disorders     
Depression * 1  1/51 (1.96%)  0/51 (0.00%) 
Renal and urinary disorders     
Acute kidney injury * 1  2/51 (3.92%)  3/51 (5.88%) 
Focal segmental glomerulosclerosis * 1  1/51 (1.96%)  0/51 (0.00%) 
Glomerulonephritis * 1  1/51 (1.96%)  0/51 (0.00%) 
Haematuria * 1  1/51 (1.96%)  2/51 (3.92%) 
Hydronephrosis * 1  2/51 (3.92%)  3/51 (5.88%) 
Nephrectasia * 1  1/51 (1.96%)  0/51 (0.00%) 
Nephrotic syndrome * 1  1/51 (1.96%)  0/51 (0.00%) 
Proteinuria * 1  1/51 (1.96%)  0/51 (0.00%) 
Renal cyst * 1  1/51 (1.96%)  0/51 (0.00%) 
Renal haemorrhage * 1  0/51 (0.00%)  1/51 (1.96%) 
Renal impairment * 1  0/51 (0.00%)  1/51 (1.96%) 
Renal injury * 1  0/51 (0.00%)  1/51 (1.96%) 
Ureteric dilatation * 1  1/51 (1.96%)  0/51 (0.00%) 
Urethral stenosis * 1  1/51 (1.96%)  0/51 (0.00%) 
Urinary incontinence * 1  1/51 (1.96%)  0/51 (0.00%) 
Vesicoureteric reflux * 1  0/51 (0.00%)  1/51 (1.96%) 
Reproductive system and breast disorders     
Haemorrhagic ovarian cyst * 1  1/51 (1.96%)  0/51 (0.00%) 
Ovarian cyst ruptured * 1  1/51 (1.96%)  0/51 (0.00%) 
Prostatomegaly * 1  1/51 (1.96%)  0/51 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Lung disorder * 1  0/51 (0.00%)  1/51 (1.96%) 
Pleural effusion * 1  0/51 (0.00%)  1/51 (1.96%) 
Pulmonary embolism * 1  0/51 (0.00%)  1/51 (1.96%) 
Pulmonary oedema * 1  1/51 (1.96%)  0/51 (0.00%) 
Social circumstances     
Convalescent * 1  1/51 (1.96%)  0/51 (0.00%) 
Surgical and medical procedures     
Nephrostomy * 1  1/51 (1.96%)  0/51 (0.00%) 
Vascular disorders     
Circulatory collapse * 1  0/51 (0.00%)  1/51 (1.96%) 
Deep vein thrombosis * 1  2/51 (3.92%)  0/51 (0.00%) 
Hypertension * 1  1/51 (1.96%)  1/51 (1.96%) 
Hypotension * 1  0/51 (0.00%)  1/51 (1.96%) 
Hypovolaemic shock * 1  1/51 (1.96%)  0/51 (0.00%) 
Lymphocele * 1  3/51 (5.88%)  5/51 (9.80%) 
Superior vena cava occlusion * 1  1/51 (1.96%)  0/51 (0.00%) 
Venous thrombosis * 1  0/51 (0.00%)  1/51 (1.96%) 
1
Term from vocabulary, MedDRA 18.1
*
Indicates events were collected by non-systematic assessment
[1]
Fatality occurred in one patient who experienced both one serious adverse event of abdominal sepsis on Day 16 and one serious adverse event of bacterial sepsis on Day 36.
[2]
High level of tacrolimus
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eculizumab Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   51/51 (100.00%)   51/51 (100.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  16/51 (31.37%)  28/51 (54.90%) 
Hypofibrinogenaemia * 1  0/51 (0.00%)  3/51 (5.88%) 
Leukopenia * 1  16/51 (31.37%)  23/51 (45.10%) 
Neutropenia * 1  1/51 (1.96%)  5/51 (9.80%) 
Thrombocytopenia * 1  2/51 (3.92%)  12/51 (23.53%) 
Cardiac disorders     
Tachycardia * 1  6/51 (11.76%)  10/51 (19.61%) 
Eye disorders     
Vision blurred * 1  4/51 (7.84%)  1/51 (1.96%) 
Gastrointestinal disorders     
Abdominal pain * 1  9/51 (17.65%)  13/51 (25.49%) 
Abdominal pain lower * 1  4/51 (7.84%)  1/51 (1.96%) 
Abdominal pain upper * 1  4/51 (7.84%)  3/51 (5.88%) 
Constipation * 1  14/51 (27.45%)  15/51 (29.41%) 
Diarrhoea * 1  22/51 (43.14%)  27/51 (52.94%) 
Dyspepsia * 1  4/51 (7.84%)  2/51 (3.92%) 
Flatulence * 1  4/51 (7.84%)  4/51 (7.84%) 
Gastrooesophageal reflux disease * 1  5/51 (9.80%)  3/51 (5.88%) 
Localised intraabdominal fluid collection * 1  0/51 (0.00%)  3/51 (5.88%) 
Mouth ulceration * 1  0/51 (0.00%)  3/51 (5.88%) 
Nausea * 1  26/51 (50.98%)  19/51 (37.25%) 
Vomiting * 1  13/51 (25.49%)  7/51 (13.73%) 
General disorders     
Asthenia * 1  10/51 (19.61%)  10/51 (19.61%) 
Chest pain * 1  7/51 (13.73%)  3/51 (5.88%) 
Chills * 1  2/51 (3.92%)  5/51 (9.80%) 
Influenza like illness * 1  2/51 (3.92%)  3/51 (5.88%) 
Malaise * 1  1/51 (1.96%)  3/51 (5.88%) 
Oedema * 1  5/51 (9.80%)  5/51 (9.80%) 
Oedema peripheral * 1  15/51 (29.41%)  21/51 (41.18%) 
Pain * 1  5/51 (9.80%)  7/51 (13.73%) 
Pyrexia * 1  12/51 (23.53%)  16/51 (31.37%) 
Immune system disorders     
Drug hypersensitivity * 1  5/51 (9.80%)  3/51 (5.88%) 
Kidney transplant rejection * 1  19/51 (37.25%)  17/51 (33.33%) 
Infections and infestations     
BK virus infection * 1  12/51 (23.53%)  9/51 (17.65%) 
Bronchitis * 1  4/51 (7.84%)  2/51 (3.92%) 
Cellulitis * 1  2/51 (3.92%)  3/51 (5.88%) 
Cytomegalovirus infection * 1  2/51 (3.92%)  4/51 (7.84%) 
Cytomegalovirus viraemia * 1  6/51 (11.76%)  3/51 (5.88%) 
Escherichia urinary tract infection * 1  4/51 (7.84%)  3/51 (5.88%) 
Gastroenteritis * 1  5/51 (9.80%)  0/51 (0.00%) 
Lower respiratory tract infection * 1  0/51 (0.00%)  3/51 (5.88%) 
Nasopharyngitis * 1  1/51 (1.96%)  8/51 (15.69%) 
Oral candidiasis * 1  5/51 (9.80%)  2/51 (3.92%) 
Pneumonia * 1  0/51 (0.00%)  4/51 (7.84%) 
Respiratory tract infection * 1  3/51 (5.88%)  1/51 (1.96%) 
Upper respiratory tract infection * 1  13/51 (25.49%)  11/51 (21.57%) 
Urinary tract infection * 1  28/51 (54.90%)  18/51 (35.29%) 
Urinary tract infection bacterial * 1  5/51 (9.80%)  1/51 (1.96%) 
Urinary tract infection enterococcal * 1  4/51 (7.84%)  0/51 (0.00%) 
Injury, poisoning and procedural complications     
Arteriovenous fistula site complication * 1  3/51 (5.88%)  1/51 (1.96%) 
Incision site pain * 1  8/51 (15.69%)  6/51 (11.76%) 
Perinephric collection * 1  3/51 (5.88%)  1/51 (1.96%) 
Procedural haemorrhage * 1  3/51 (5.88%)  1/51 (1.96%) 
Procedural pain * 1  7/51 (13.73%)  8/51 (15.69%) 
Toxicity to various agents * 1  2/51 (3.92%)  6/51 (11.76%) 
Wound secretion * 1  0/51 (0.00%)  4/51 (7.84%) 
Investigations     
Antibody test positive * 1  3/51 (5.88%)  0/51 (0.00%) 
Blood creatinine increased * 1  9/51 (17.65%)  12/51 (23.53%) 
Liver function test abnormal * 1  7/51 (13.73%)  5/51 (9.80%) 
Weight decreased * 1  2/51 (3.92%)  3/51 (5.88%) 
Weight increased * 1  5/51 (9.80%)  4/51 (7.84%) 
Metabolism and nutrition disorders     
Acidosis * 1  1/51 (1.96%)  3/51 (5.88%) 
Decreased appetite * 1  6/51 (11.76%)  4/51 (7.84%) 
Dehydration * 1  2/51 (3.92%)  4/51 (7.84%) 
Diabetes mellitus * 1  4/51 (7.84%)  9/51 (17.65%) 
Diabetes mellitus inadequate control * 1  5/51 (9.80%)  2/51 (3.92%) 
Fluid overload * 1  4/51 (7.84%)  6/51 (11.76%) 
Hypercalcaemia * 1  3/51 (5.88%)  5/51 (9.80%) 
Hyperglycaemia * 1  14/51 (27.45%)  16/51 (31.37%) 
Hyperkalaemia * 1  10/51 (19.61%)  15/51 (29.41%) 
Hyperlipidaemia * 1  4/51 (7.84%)  1/51 (1.96%) 
Hyperphosphataemia * 1  3/51 (5.88%)  4/51 (7.84%) 
Hypocalcaemia * 1  14/51 (27.45%)  13/51 (25.49%) 
Hypokalaemia * 1  11/51 (21.57%)  10/51 (19.61%) 
Hypomagnesaemia * 1  13/51 (25.49%)  13/51 (25.49%) 
Hyponatraemia * 1  6/51 (11.76%)  2/51 (3.92%) 
Hypophosphataemia * 1  16/51 (31.37%)  12/51 (23.53%) 
Metabolic acidosis * 1  12/51 (23.53%)  10/51 (19.61%) 
Vitamin D deficiency * 1  8/51 (15.69%)  6/51 (11.76%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  6/51 (11.76%)  10/51 (19.61%) 
Muscular weakness * 1  1/51 (1.96%)  3/51 (5.88%) 
Musculoskeletal pain * 1  11/51 (21.57%)  8/51 (15.69%) 
Osteopenia * 1  4/51 (7.84%)  1/51 (1.96%) 
Osteoporosis * 1  3/51 (5.88%)  2/51 (3.92%) 
Nervous system disorders     
Dizziness * 1  7/51 (13.73%)  6/51 (11.76%) 
Headache * 1  14/51 (27.45%)  9/51 (17.65%) 
Migraine * 1  4/51 (7.84%)  2/51 (3.92%) 
Tremor * 1  14/51 (27.45%)  14/51 (27.45%) 
Psychiatric disorders     
Anxiety * 1  8/51 (15.69%)  6/51 (11.76%) 
Depression * 1  2/51 (3.92%)  3/51 (5.88%) 
Insomnia * 1  7/51 (13.73%)  11/51 (21.57%) 
Renal and urinary disorders     
Acute kidney injury * 1  4/51 (7.84%)  3/51 (5.88%) 
Anuria * 1  0/51 (0.00%)  4/51 (7.84%) 
Bladder spasm * 1  3/51 (5.88%)  2/51 (3.92%) 
Dysuria * 1  3/51 (5.88%)  4/51 (7.84%) 
Haematuria * 1  5/51 (9.80%)  10/51 (19.61%) 
Nocturia * 1  3/51 (5.88%)  0/51 (0.00%) 
Oliguria * 1  2/51 (3.92%)  6/51 (11.76%) 
Polyuria * 1  6/51 (11.76%)  4/51 (7.84%) 
Proteinuria * 1  9/51 (17.65%)  6/51 (11.76%) 
Renal impairment * 1  4/51 (7.84%)  2/51 (3.92%) 
Renal tubular necrosis * 1  2/51 (3.92%)  4/51 (7.84%) 
Urinary retention * 1  1/51 (1.96%)  3/51 (5.88%) 
Respiratory, thoracic and mediastinal disorders     
Atelectasis * 1  3/51 (5.88%)  2/51 (3.92%) 
Cough * 1  5/51 (9.80%)  6/51 (11.76%) 
Dyspnoea * 1  5/51 (9.80%)  6/51 (11.76%) 
Dyspnoea exertional * 1  0/51 (0.00%)  3/51 (5.88%) 
Pulmonary oedema * 1  0/51 (0.00%)  3/51 (5.88%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  5/51 (9.80%)  9/51 (17.65%) 
Pruritus * 1  9/51 (17.65%)  9/51 (17.65%) 
Rash * 1  5/51 (9.80%)  3/51 (5.88%) 
Vascular disorders     
Deep vein thrombosis * 1  4/51 (7.84%)  1/51 (1.96%) 
Haematoma * 1  2/51 (3.92%)  3/51 (5.88%) 
Hypertension * 1  13/51 (25.49%)  15/51 (29.41%) 
Hypotension * 1  8/51 (15.69%)  11/51 (21.57%) 
Lymphocele * 1  3/51 (5.88%)  3/51 (5.88%) 
1
Term from vocabulary, MedDRA 18.1
*
Indicates events were collected by non-systematic assessment
Data interpretation confounded by open-label study with potential reporting bias, unequal exposure to randomized prevention therapy between groups, some patients in SOC arm received eculizumab for treatment of AMR, all patients immunosuppressed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Alexion Pharmaceuticals, Inc.
Organization: Alexion Pharmaceuticals, Inc.
Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01399593     History of Changes
Other Study ID Numbers: C10-001
2010-019630-28 ( EudraCT Number )
BB-IND: 100,003 ( Other Identifier: FDA IND: 100,003 )
First Submitted: July 19, 2011
First Posted: July 22, 2011
Results First Submitted: March 9, 2017
Results First Posted: April 19, 2017
Last Update Posted: October 3, 2017