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An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access

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ClinicalTrials.gov Identifier: NCT01806545
Recruitment Status : Completed
First Posted : March 7, 2013
Results First Posted : December 24, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Arteriovenous Fistula
Interventions Biological: SRM003
Other: Participating Site's standard practice
Enrollment 64

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Participating Site's Standard Practice SRM003
Hide Arm/Group Description Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety. Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Period Title: Overall Study
Started 29 35
Completed 23 30
Not Completed 6 5
Reason Not Completed
Adverse Event             2             3
Lost to Follow-up             1             0
Withdrawal by Subject             3             2
Arm/Group Title Participating Site's Standard Practice SRM003 Total
Hide Arm/Group Description Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety. Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety. Total of all reporting groups
Overall Number of Baseline Participants 29 35 64
Hide Baseline Analysis Population Description
The Intent -to-Treat (ITT) population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 35 participants 64 participants
65.2  (13.5) 61.1  (10.8) 63.0  (12.2)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 35 participants 64 participants
<65 years 12 23 35
≥65 years 17 12 29
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 35 participants 64 participants
Female
11
  37.9%
13
  37.1%
24
  37.5%
Male
18
  62.1%
22
  62.9%
40
  62.5%
1.Primary Outcome
Title Percentage of Participants With Arteriovenous Fistula (AVF) Maturation by Week 12 Visit Based on Hemodialysis or Color-flow Doppler Ultrasound (CDUS) And Vascular Access Examination
Hide Description Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 12 visit without assessment of maturity were considered treatment failures.
Time Frame 12 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent- to-Treat (ITT) population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
Arm/Group Title Participating Site's Standard Practice SRM003
Hide Arm/Group Description:
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Overall Number of Participants Analyzed 29 35
Measure Type: Number
Unit of Measure: percentage of participants
96.6 85.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participating Site's Standard Practice, SRM003
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1197
Comments P-value was based on Cochran-Mantel-Haenszel test stratified by diabetic status at surgery comparing the 2 treatment groups.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion treatment difference
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.242 to 0.025
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With AVF Maturation by Week 26 Visit Based on Hemodialysis or CDUS And Vascular Access Examination
Hide Description Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 26 visit without assessment of maturity were considered treatment failures.
Time Frame 26 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
Arm/Group Title Participating Site's Standard Practice SRM003
Hide Arm/Group Description:
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Overall Number of Participants Analyzed 29 35
Measure Type: Number
Unit of Measure: percentage of participants
96.6 88.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participating Site's Standard Practice, SRM003
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1962
Comments P-value was based on Cochran-Mantel-Haenszel test stratified by diabetic status at surgery comparing the 2 treatment groups.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion treatment difference
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.204 to 0.045
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to AVF Maturation Based on Hemodialysis or CDUS and Vascular Access Examination
Hide Description Time to AVF maturation was defined as the duration of time (in days) from the date of randomization (AVF creation) to the date of maturation, where the date of maturation corresponds to the earlier of either the date of the first use of the study AVF for hemodialysis as determined by the investigator following discussion with the participant, or the date the AVF meets all of the following 3 criteria as determined through CDUS and vascular access examination: presence of bruit throughout systole and diastole at least 8 centimeters proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Participants who died, underwent a kidney transplant, or were either lost to follow-up or did not mature during the study follow-up were censored at the time of death, time of transplant, or time of last visit, respectively.
Time Frame Up to 26 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
Arm/Group Title Participating Site's Standard Practice SRM003
Hide Arm/Group Description:
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Overall Number of Participants Analyzed 29 35
Median (Inter-Quartile Range)
Unit of Measure: days
9
(8 to 28)
10
(8 to 59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participating Site's Standard Practice, SRM003
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.090
Comments P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Loss of Unassisted Primary Patency
Hide Description The time to loss of unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) any intervention designed to establish, maintain, or restore patency; (b) occlusion (commonly due to thrombosis); or (c) access abandonment.
Time Frame Up to 26 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
Arm/Group Title Participating Site's Standard Practice SRM003
Hide Arm/Group Description:
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Overall Number of Participants Analyzed 29 35
Measure Type: Number
Unit of Measure: percentage of participants
20.7 37.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participating Site's Standard Practice, SRM003
Comments Analysis of time to loss of patency
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.193
Comments [Not Specified]
Method Log Rank
Comments P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.
5.Secondary Outcome
Title Percentage of Participants With Loss of Assisted Primary Patency
Hide Description The time to loss of assisted primary patency (thrombosis--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) occlusion (commonly due to thrombosis) or (b) access abandonment.
Time Frame Up to 26 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
Arm/Group Title Participating Site's Standard Practice SRM003
Hide Arm/Group Description:
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Overall Number of Participants Analyzed 29 35
Measure Type: Number
Unit of Measure: percentage of participants
6.9 17.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participating Site's Standard Practice, SRM003
Comments Analysis of time to loss of patency
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.231
Comments P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.
Method Log Rank
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Loss of Secondary Patency
Hide Description The time to loss of secondary patency (access survival until abandonment) was defined as the duration of time in days from the date of randomization (AVF creation) until the date of access abandonment.
Time Frame Up to 26 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
Arm/Group Title Participating Site's Standard Practice SRM003
Hide Arm/Group Description:
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Overall Number of Participants Analyzed 29 35
Measure Type: Number
Unit of Measure: percentage of participants
3.4 14.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participating Site's Standard Practice, SRM003
Comments Analysis of time to loss of patency
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.158
Comments P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.
Method Log Rank
Comments [Not Specified]
7.Secondary Outcome
Title Change From Week 1 in Average Vascular Access Lumen Diameter Using CDUS
Hide Description B-mode lumen diameter measurements were obtained in the outflow vein as 3 separate images for each location: at 1, 3, and 5 centimeter into the vein and from the toe of the venous anastomosis. The average of lumen diameter measurements obtained at 1, 3, and 5 cm from the anastomosis was used for this endpoint.
Time Frame 1, 12, and 26 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
Arm/Group Title Participating Site's Standard Practice SRM003
Hide Arm/Group Description:
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Overall Number of Participants Analyzed 29 35
Mean (Standard Deviation)
Unit of Measure: millimeters
Week 12, n=21, 28 1.897  (1.2587) 1.253  (1.9908)
Week 26, n=20, 25 2.489  (1.4525) 2.416  (2.3941)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participating Site's Standard Practice, SRM003
Comments Treatment difference at week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean treatment difference
Estimated Value -0.895
Confidence Interval (2-Sided) 95%
-2.213 to 0.423
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participating Site's Standard Practice, SRM003
Comments Treatment difference at week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean treatment difference
Estimated Value -0.232
Confidence Interval (2-Sided) 95%
-1.791 to 1.327
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Clinical Success Based on First Use of The Study AVF For Hemodialysis
Hide Description Clinical success was defined as the ability to undergo hemodialysis using the AVF. The date of clinical success corresponded to the date of the first use of the study AVF for hemodialysis as determined by the investigator, following discussion with the subject. Clinical success was assessed in a continuous fashion and, once achieved, the AVF was considered a clinical success at that and all subsequent time points. The date of clinical success based on the first use of the AVF for hemodialysis was compared with the dates of each study visit (Week 12 and Week 26); for study visits occurring prior to the date of clinical success based on the first use of the AVF for hemodialysis, the subject was counted as a nonsuccess and for study visits occurring on or after the date of maturation based on the first use of the AVF for hemodialysis, the subject was counted as a success.
Time Frame 12 and 26 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
Arm/Group Title Participating Site's Standard Practice SRM003
Hide Arm/Group Description:
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Overall Number of Participants Analyzed 29 35
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 37.9 34.3
Week 26 55.2 62.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participating Site's Standard Practice, SRM003
Comments Analysis of week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion treatment difference
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.273 to 0.200
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participating Site's Standard Practice, SRM003
Comments Analysis of week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion treatment difference
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.165 to 0.318
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Interventions to Establish, Maintain, or Restore Patency
Hide Description The total number of interventions to establish, maintain, or restore patency was recorded for each participant.
Time Frame 12 and 26 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
Arm/Group Title Participating Site's Standard Practice SRM003
Hide Arm/Group Description:
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
Overall Number of Participants Analyzed 29 35
Mean (Standard Deviation)
Unit of Measure: interventions
Week 12 0.1  (0.31) 0.3  (0.61)
Week 26 0.2  (0.49) 0.8  (1.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participating Site's Standard Practice, SRM003
Comments Analysis of week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean treatment difference
Estimated Value 0.154
Confidence Interval (2-Sided) 95%
-0.096 to 0.404
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participating Site's Standard Practice, SRM003
Comments Analysis of week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean treatment difference
Estimated Value 0.565
Confidence Interval (2-Sided) 95%
-0.023 to 1.152
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites’ standard practice treatments.
 
Arm/Group Title Participating Site's Standard Practice SRM003
Hide Arm/Group Description Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety. Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
All-Cause Mortality
Participating Site's Standard Practice SRM003
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Participating Site's Standard Practice SRM003
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/29 (55.17%)      13/35 (37.14%)    
Cardiac disorders     
Acute myocardial infarction  1  2/29 (6.90%)  3 2/35 (5.71%)  2
Cardiac failure congestive  1  2/29 (6.90%)  2 1/35 (2.86%)  1
Arrhythmia  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Atrial fibrillation  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Cardiac arrest  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Cardiac failure chronic  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Coronary artery disease  1  1/29 (3.45%)  1 0/35 (0.00%)  0
Myocardial infarction  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Pericardial effusion  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Gastrointestinal disorders     
Abdominal pain  1  0/29 (0.00%)  0 2/35 (5.71%)  2
Constipation  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Diarrhoea haemorrhagic  1  1/29 (3.45%)  1 0/35 (0.00%)  0
Gastrointestinal haemorrhage  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Nausea  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Vomiting  1  0/29 (0.00%)  0 1/35 (2.86%)  1
General disorders     
Non cardiac chest pain  1  2/29 (6.90%)  2 0/35 (0.00%)  0
Chest pain  1  1/29 (3.45%)  1 1/35 (2.86%)  1
Influenza like illness  1  1/29 (3.45%)  1 0/35 (0.00%)  0
Pyrexia  1  1/29 (3.45%)  1 0/35 (0.00%)  0
Infections and infestations     
Pneumonia  1  2/29 (6.90%)  2 0/35 (0.00%)  0
Catheter site infection  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Lower respiratory tract infection  1  1/29 (3.45%)  1 0/35 (0.00%)  0
Sepsis  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Injury, poisoning and procedural complications     
Arteriovenous fistula site complication  1  0/29 (0.00%)  0 1/35 (2.86%)  2
Fall  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Pelvic fracture  1  1/29 (3.45%)  1 0/35 (0.00%)  0
Metabolism and nutrition disorders     
Hyperkalaemia  1  1/29 (3.45%)  1 2/35 (5.71%)  2
Fluid overload  1  2/29 (6.90%)  2 1/35 (2.86%)  3
Hypoglycaemia  1  1/29 (3.45%)  1 0/35 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Musculoskeletal pain  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Nervous system disorders     
Cerebrovascular accident  1  1/29 (3.45%)  1 0/35 (0.00%)  0
Convulsion  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Encephalopathy  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Ischaemic stroke  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Syncope  1  1/29 (3.45%)  1 0/35 (0.00%)  0
Psychiatric disorders     
Mental status changes  1  1/29 (3.45%)  1 0/35 (0.00%)  0
Renal and urinary disorders     
Renal failure chronic  1  1/29 (3.45%)  1 3/35 (8.57%)  3
Renal failure acute  1  1/29 (3.45%)  1 0/35 (0.00%)  0
Urinary retention  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/29 (3.45%)  1 0/35 (0.00%)  0
Dyspnoea  1  1/29 (3.45%)  1 1/35 (2.86%)  1
Pulmonary oedema  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Respiratory failure  1  1/29 (3.45%)  1 0/35 (0.00%)  0
Vascular disorders     
Steal syndrome  1  2/29 (6.90%)  2 0/35 (0.00%)  0
Hypertension  1  1/29 (3.45%)  2 0/35 (0.00%)  0
Hypertensive emergency  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Orthostatic hypotension  1  0/29 (0.00%)  0 1/35 (2.86%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Participating Site's Standard Practice SRM003
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/29 (58.62%)      25/35 (71.43%)    
Blood and lymphatic system disorders     
Anaemia  1  2/29 (6.90%)  2 1/35 (2.86%)  1
Cardiac disorders     
Atrial fibrillation  1  2/29 (6.90%)  2 0/35 (0.00%)  0
Cardiac failure congestive  1  2/29 (6.90%)  2 0/35 (0.00%)  0
Gastrointestinal disorders     
Constipation  1  0/29 (0.00%)  0 3/35 (8.57%)  3
Nausea  1  3/29 (10.34%)  3 4/35 (11.43%)  4
Vomiting  1  1/29 (3.45%)  1 3/35 (8.57%)  3
General disorders     
Fatigue  1  0/29 (0.00%)  0 3/35 (8.57%)  3
Local swelling  1  2/29 (6.90%)  2 3/35 (8.57%)  3
Medical device complication  1  0/29 (0.00%)  0 3/35 (8.57%)  5
Non-cardiac chest pain  1  2/29 (6.90%)  2 0/35 (0.00%)  0
Oedema peripheral  1  0/29 (0.00%)  0 2/35 (5.71%)  2
Pain  1  0/29 (0.00%)  0 2/35 (5.71%)  2
Infections and infestations     
Upper respiratory tract infection  1  2/29 (6.90%)  2 1/35 (2.86%)  1
Urinary tract infection  1  1/29 (3.45%)  1 2/35 (5.71%)  2
Injury, poisoning and procedural complications     
Arteriovenous fistula occlusion  1  1/29 (3.45%)  1 2/35 (5.71%)  2
Arteriovenous fistula site complication  1  5/29 (17.24%)  8 7/35 (20.00%)  12
Arteriovenous fistula thrombosis  1  0/29 (0.00%)  0 3/35 (8.57%)  3
Laceration  1  2/29 (6.90%)  2 1/35 (2.86%)  1
Procedural pain  1  2/29 (6.90%)  2 2/35 (5.71%)  2
Wound dehiscence  1  0/29 (0.00%)  0 2/35 (5.71%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/29 (0.00%)  0 2/35 (5.71%)  2
Back pain  1  1/29 (3.45%)  1 2/35 (5.71%)  2
Muscle spasms  1  1/29 (3.45%)  1 3/35 (8.57%)  3
Pain in extremity  1  2/29 (6.90%)  2 3/35 (8.57%)  3
Nervous system disorders     
Dizziness  1  0/29 (0.00%)  0 3/35 (8.57%)  3
Hypoaesthesia  1  4/29 (13.79%)  5 2/35 (5.71%)  3
Paraesthesia  1  1/29 (3.45%)  1 3/35 (8.57%)  3
Psychiatric disorders     
Insomnia  1  0/29 (0.00%)  0 3/35 (8.57%)  3
Renal and urinary disorders     
Renal failure chronic  1  2/29 (6.90%)  4 1/35 (2.86%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/29 (10.34%)  3 1/35 (2.86%)  1
Dyspnoea  1  2/29 (6.90%)  2 2/35 (5.71%)  2
Skin and subcutaneous tissue disorders     
Ecchymosis  1  2/29 (6.90%)  2 0/35 (0.00%)  0
Pruritus  1  0/29 (0.00%)  0 2/35 (5.71%)  2
Vascular disorders     
Haematoma  1  2/29 (6.90%)  2 0/35 (0.00%)  0
Hypotension  1  3/29 (10.34%)  3 3/35 (8.57%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually
Results Point of Contact
Name/Title: Study Physician
Organization: Shire Development LLC
Phone: +1 866 842 5335
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01806545     History of Changes
Other Study ID Numbers: AVF01-SRM003
First Submitted: March 5, 2013
First Posted: March 7, 2013
Results First Submitted: October 16, 2015
Results First Posted: December 24, 2015
Last Update Posted: December 24, 2015