Trial Outcomes & Findings for A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2) (NCT NCT02414841)
NCT ID: NCT02414841
Last Updated: 2019-08-13
Results Overview
Kaplan-Meier estimate of median time from AVF creation until AVF abandonment (secondary patency)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
696 participants
Primary outcome timeframe
Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year.
Results posted on
2019-08-13
Participant Flow
696 patients signed informed consent; 613 patients were randomized; 603 were treated
Participants were excluded if they did not have a radiocephalic fistula created at the time of surgery
Participant milestones
| Measure |
Vonapanitase
Vonapanitase administered at the time of radiocephalic fistula creation
vonapanitase
|
Placebo
Placebo administered at the time of radiocephalic fistula creation
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
405
|
208
|
|
Overall Study
COMPLETED
|
349
|
175
|
|
Overall Study
NOT COMPLETED
|
56
|
33
|
Reasons for withdrawal
| Measure |
Vonapanitase
Vonapanitase administered at the time of radiocephalic fistula creation
vonapanitase
|
Placebo
Placebo administered at the time of radiocephalic fistula creation
Placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
|
Overall Study
Lost to Follow-up
|
13
|
6
|
|
Overall Study
Death
|
17
|
14
|
|
Overall Study
Received a Kidney Transplant
|
13
|
4
|
|
Overall Study
Randomized But Not Treated
|
6
|
4
|
Baseline Characteristics
A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2)
Baseline characteristics by cohort
| Measure |
Vonapanitase
n=405 Participants
Vonapanitase administered at the time of radiocephalic fistula creation
|
Placebo
n=208 Participants
Placebo administered at the time of radiocephalic fistula creation
|
Total
n=613 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
277 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
409 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
128 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
304 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
466 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
104 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
269 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
418 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
41 participants
n=5 Participants
|
18 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
358 participants
n=5 Participants
|
186 participants
n=7 Participants
|
544 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year.Population: Full analysis set includes all 613 patients who were randomized
Kaplan-Meier estimate of median time from AVF creation until AVF abandonment (secondary patency)
Outcome measures
| Measure |
Vonapanitase
n=405 Participants
Vonapanitase administered at the time of radiocephalic fistula creation
Vonapanitase
|
Placebo
n=208 Participants
Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition of vonapanitase but lacks the active ingredient.
Placebo
|
|---|---|---|
|
Kaplan-Meier Estimate of Secondary AVF Patency
|
NA Days
The median time to the event based on Kaplan-Meier estimates was not reached in this trial
|
NA Days
The median time to the event based on Kaplan-Meier estimates was not reached in this trial
|
PRIMARY outcome
Timeframe: Assessed at up to 12 MonthsPopulation: Patients having use or non-use of their AVF. Patients with indeterminate use of their AVF were excluded.
AVF use for hemodialysis is defined as the ability of the study AVF to be successfully cannulated and used for hemodialysis for a minimum of 90 days or at least 30 days prior to a patient's last visit, if hemodialysis has not been initiated at least 90 days prior to the patient's last visit. If AVF use is not defined as above, non-use of the AVF for hemodialysis is defined as an abandoned fistula prior to use; or if hemodialysis is recorded on 2 consecutive visits and there is no cannulation date or duration of use is less than 90 days. The patients who are not categorized as having use or non-use of the AVF have insufficient data to determine AVF use for hemodialysis and will be categorized as having indeterminate use.
Outcome measures
| Measure |
Vonapanitase
n=405 Participants
Vonapanitase administered at the time of radiocephalic fistula creation
Vonapanitase
|
Placebo
n=208 Participants
Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition of vonapanitase but lacks the active ingredient.
Placebo
|
|---|---|---|
|
Number of Participants With AVF Use for Hemodialysis
AVF Used
|
209 Participants
|
99 Participants
|
|
Number of Participants With AVF Use for Hemodialysis
AVF Not Used
|
91 Participants
|
53 Participants
|
|
Number of Participants With AVF Use for Hemodialysis
Indeterminant AVF Use
|
105 Participants
|
56 Participants
|
Adverse Events
Vonapanitase
Serious events: 48 serious events
Other events: 247 other events
Deaths: 17 deaths
Placebo
Serious events: 30 serious events
Other events: 135 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Vonapanitase
n=399 participants at risk
Vonapanitase administered at the time of radiocephalic fistula creation
|
Placebo
n=204 participants at risk
Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition of vonapanitase but lacks the active ingredient.
|
|---|---|---|
|
Cardiac disorders
Pulseless Electrical Activity
|
0.00%
0/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.00%
0/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
1.5%
3/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Infections and infestations
Sepsis
|
0.50%
2/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Cardiac disorders
Cardiac Arrest
|
0.50%
2/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
2.5%
5/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Renal and urinary disorders
Renal Failure
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.98%
2/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.00%
0/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Vascular disorders
Venous Thrombosis
|
0.00%
0/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Vascular disorders
Steal Syndrome
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Surgical and medical procedures
Toe Surgery
|
0.00%
0/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Infections and infestations
Pneumonia
|
1.0%
4/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
2.0%
4/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.98%
2/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Thrombosis
|
1.8%
7/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Vascular disorders
Hypertension
|
0.00%
0/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.00%
0/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
General disorders
Pyrexia
|
0.00%
0/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Vascular disorders
Haematoma
|
0.00%
0/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.98%
2/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.49%
1/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Metabolism and nutrition disorders
Calciphylaxis
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
General disorders
Device Kink
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Vascular disorders
Collateral Circulation
|
0.50%
2/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Psychiatric disorders
Confusional State
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Vascular disorders
Vascular Stenosis
|
0.50%
2/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.50%
2/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Nervous system disorders
Syncope
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
General disorders
Chest Pain
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Nervous system disorders
Presyncope
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
General disorders
Unknown Cause of Death
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Infections and infestations
Post Procedural Infection
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Infections and infestations
Osteomyelitis
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
General disorders
Sudden Death
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Vascular disorders
Circulatory Collapse
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Infections and infestations
Bacteraemia
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Renal and urinary disorders
Azotaemia
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Cardiac disorders
Cardiac Failure
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Cardiac disorders
Myocardial infarction
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
General disorders
Generalised Oedema
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.25%
1/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
0.00%
0/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
Other adverse events
| Measure |
Vonapanitase
n=399 participants at risk
Vonapanitase administered at the time of radiocephalic fistula creation
|
Placebo
n=204 participants at risk
Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition of vonapanitase but lacks the active ingredient.
|
|---|---|---|
|
General disorders
Local Swelling
|
5.0%
20/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
2.0%
4/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Thrombosis
|
16.8%
67/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
18.6%
38/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Vascular disorders
Vascular Stenosis
|
35.1%
140/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
41.7%
85/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
|
Vascular disorders
Haematoma
|
5.0%
20/399 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
3.9%
8/204 • All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place