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A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2)

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ClinicalTrials.gov Identifier: NCT02414841
Recruitment Status : Completed
First Posted : April 13, 2015
Results First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Proteon Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Kidney Disease
Interventions Drug: Vonapanitase
Drug: Placebo
Enrollment 696
Recruitment Details 696 patients signed informed consent; 613 patients were randomized; 603 were treated
Pre-assignment Details Participants were excluded if they did not have a radiocephalic fistula created at the time of surgery
Arm/Group Title Vonapanitase Placebo
Hide Arm/Group Description

Vonapanitase administered at the time of radiocephalic fistula creation

vonapanitase

Placebo administered at the time of radiocephalic fistula creation

Placebo

Period Title: Overall Study
Started 405 208
Completed 349 175
Not Completed 56 33
Reason Not Completed
Withdrawal by Subject             7             5
Lost to Follow-up             13             6
Death             17             14
Received a Kidney Transplant             13             4
Randomized But Not Treated             6             4
Arm/Group Title Vonapanitase Placebo Total
Hide Arm/Group Description Vonapanitase administered at the time of radiocephalic fistula creation Placebo administered at the time of radiocephalic fistula creation Total of all reporting groups
Overall Number of Baseline Participants 405 208 613
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 405 participants 208 participants 613 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
277
  68.4%
132
  63.5%
409
  66.7%
>=65 years
128
  31.6%
76
  36.5%
204
  33.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 405 participants 208 participants 613 participants
Female
101
  24.9%
46
  22.1%
147
  24.0%
Male
304
  75.1%
162
  77.9%
466
  76.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 405 participants 208 participants 613 participants
American Indian or Alaska Native
3
   0.7%
0
   0.0%
3
   0.5%
Asian
19
   4.7%
10
   4.8%
29
   4.7%
Native Hawaiian or Other Pacific Islander
3
   0.7%
1
   0.5%
4
   0.7%
Black or African American
104
  25.7%
45
  21.6%
149
  24.3%
White
269
  66.4%
149
  71.6%
418
  68.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
7
   1.7%
3
   1.4%
10
   1.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 405 participants 208 participants 613 participants
Canada 41 18 59
United States 358 186 544
1.Primary Outcome
Title Kaplan-Meier Estimate of Secondary AVF Patency
Hide Description Kaplan-Meier estimate of median time from AVF creation until AVF abandonment (secondary patency)
Time Frame Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set includes all 613 patients who were randomized
Arm/Group Title Vonapanitase Placebo
Hide Arm/Group Description:

Vonapanitase administered at the time of radiocephalic fistula creation

Vonapanitase

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

Overall Number of Participants Analyzed 405 208
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The median time to the event based on Kaplan-Meier estimates was not reached in this trial
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vonapanitase, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.932
Comments [Not Specified]
Method Log Rank
Comments Weighted
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.67 to 1.39
Estimation Comments Performed as sensitivity analysis
2.Primary Outcome
Title Number of Participants With AVF Use for Hemodialysis
Hide Description 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.
Time Frame Assessed at up to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients having use or non-use of their AVF. Patients with indeterminate use of their AVF were excluded.
Arm/Group Title Vonapanitase Placebo
Hide Arm/Group Description:
Vonapanitase administered at the time of radiocephalic fistula creation
Placebo administered at the time of radiocephalic fistula creation
Overall Number of Participants Analyzed 405 208
Measure Type: Count of Participants
Unit of Measure: Participants
AVF Used
209
  51.6%
99
  47.6%
AVF Not Used
91
  22.5%
53
  25.5%
Indeterminant AVF Use
105
  25.9%
56
  26.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vonapanitase, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.328
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame All Adverse Events (AE) through Week 4; Only AEs associated with the AVF extremity Week 4-Month 12.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vonapanitase Placebo
Hide Arm/Group Description Vonapanitase administered at the time of radiocephalic fistula creation Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition of vonapanitase but lacks the active ingredient.
All-Cause Mortality
Vonapanitase Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   17/399 (4.26%)   14/204 (6.86%) 
Hide Serious Adverse Events
Vonapanitase Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   48/399 (12.03%)   30/204 (14.71%) 
Cardiac disorders     
Pulseless Electrical Activity  1  0/399 (0.00%)  1/204 (0.49%) 
Cardiac Arrest  1  2/399 (0.50%)  5/204 (2.45%) 
Acute Myocardial Infarction  1  0/399 (0.00%)  1/204 (0.49%) 
Cardiac Failure Congestive  1  1/399 (0.25%)  0/204 (0.00%) 
Cardio-Respiratory Arrest  1  1/399 (0.25%)  0/204 (0.00%) 
Coronary Artery Disease  1  1/399 (0.25%)  0/204 (0.00%) 
Cardiac Failure  1  1/399 (0.25%)  0/204 (0.00%) 
Myocardial infarction  1  1/399 (0.25%)  0/204 (0.00%) 
Gastrointestinal disorders     
Lower Gastrointestinal Haemorrhage  1  0/399 (0.00%)  1/204 (0.49%) 
Pancreatitis  1  1/399 (0.25%)  0/204 (0.00%) 
Pancreatitis Acute  1  1/399 (0.25%)  0/204 (0.00%) 
Small Intestinal Obstruction  1  1/399 (0.25%)  0/204 (0.00%) 
Gastrointestinal Haemorrhage  1  1/399 (0.25%)  0/204 (0.00%) 
General disorders     
Pyrexia  1  0/399 (0.00%)  1/204 (0.49%) 
Device Kink  1  1/399 (0.25%)  0/204 (0.00%) 
Chest Pain  1  1/399 (0.25%)  0/204 (0.00%) 
Unknown Cause of Death  1  1/399 (0.25%)  0/204 (0.00%) 
Sudden Death  1  1/399 (0.25%)  0/204 (0.00%) 
Generalised Oedema  1  1/399 (0.25%)  0/204 (0.00%) 
Infections and infestations     
Sepsis  1  2/399 (0.50%)  1/204 (0.49%) 
Cytomegalovirus infection  1  0/399 (0.00%)  1/204 (0.49%) 
Pneumonia  1  4/399 (1.00%)  4/204 (1.96%) 
Pulmonary Tuberculosis  1  0/399 (0.00%)  1/204 (0.49%) 
Septic Shock  1  0/399 (0.00%)  1/204 (0.49%) 
Post Procedural Infection  1  1/399 (0.25%)  0/204 (0.00%) 
Osteomyelitis  1  1/399 (0.25%)  0/204 (0.00%) 
Bacteraemia  1  1/399 (0.25%)  0/204 (0.00%) 
Injury, poisoning and procedural complications     
Humerus fracture  1  0/399 (0.00%)  1/204 (0.49%) 
Arteriovenous Fistula Thrombosis  1  7/399 (1.75%)  1/204 (0.49%) 
Procedural Pain  1  2/399 (0.50%)  0/204 (0.00%) 
Seroma  1  1/399 (0.25%)  0/204 (0.00%) 
Metabolism and nutrition disorders     
Fluid Overload  1  0/399 (0.00%)  3/204 (1.47%) 
Calciphylaxis  1  1/399 (0.25%)  0/204 (0.00%) 
Hyperkalaemia  1  1/399 (0.25%)  0/204 (0.00%) 
Hypoglycaemia  1  1/399 (0.25%)  0/204 (0.00%) 
Musculoskeletal and connective tissue disorders     
Rhabdomyolysis  1  0/399 (0.00%)  1/204 (0.49%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma  1  1/399 (0.25%)  0/204 (0.00%) 
Pancreatic Carcinoma  1  1/399 (0.25%)  0/204 (0.00%) 
Nervous system disorders     
Cerebral Haemorrhage  1  0/399 (0.00%)  1/204 (0.49%) 
Syncope  1  1/399 (0.25%)  0/204 (0.00%) 
Presyncope  1  1/399 (0.25%)  0/204 (0.00%) 
Psychiatric disorders     
Confusional State  1  1/399 (0.25%)  0/204 (0.00%) 
Renal and urinary disorders     
Renal Failure  1  1/399 (0.25%)  2/204 (0.98%) 
Renal Failure Chronic  1  1/399 (0.25%)  2/204 (0.98%) 
Renal Failure Acute  1  1/399 (0.25%)  1/204 (0.49%) 
Azotaemia  1  1/399 (0.25%)  0/204 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pleural Effusion  1  0/399 (0.00%)  1/204 (0.49%) 
Pulmonary Embolism  1  1/399 (0.25%)  0/204 (0.00%) 
Aspiration  1  1/399 (0.25%)  0/204 (0.00%) 
Acute Respiratory Failure  1  1/399 (0.25%)  0/204 (0.00%) 
Pulmonary Oedema  1  1/399 (0.25%)  0/204 (0.00%) 
Surgical and medical procedures     
Toe Surgery  1  0/399 (0.00%)  1/204 (0.49%) 
Vascular disorders     
Venous Thrombosis  1  0/399 (0.00%)  1/204 (0.49%) 
Steal Syndrome  1  1/399 (0.25%)  1/204 (0.49%) 
Hypertension  1  0/399 (0.00%)  1/204 (0.49%) 
Deep Vein Thrombosis  1  0/399 (0.00%)  1/204 (0.49%) 
Haematoma  1  0/399 (0.00%)  2/204 (0.98%) 
Collateral Circulation  1  2/399 (0.50%)  0/204 (0.00%) 
Vascular Stenosis  1  2/399 (0.50%)  0/204 (0.00%) 
Circulatory Collapse  1  1/399 (0.25%)  0/204 (0.00%) 
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vonapanitase Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   247/399 (61.90%)   135/204 (66.18%) 
General disorders     
Local Swelling  1  20/399 (5.01%)  4/204 (1.96%) 
Injury, poisoning and procedural complications     
Arteriovenous Fistula Thrombosis  1  67/399 (16.79%)  38/204 (18.63%) 
Vascular disorders     
Vascular Stenosis  1  140/399 (35.09%)  85/204 (41.67%) 
Haematoma  1  20/399 (5.01%)  8/204 (3.92%) 
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Steven Burke, MD
Organization: Proteon Therapeutics, Inc
Phone: 781-890-0102
EMail: Clinical@ProteonTx.com
Layout table for additonal information
Responsible Party: Proteon Therapeutics
ClinicalTrials.gov Identifier: NCT02414841    
Other Study ID Numbers: PRT-201-320
First Submitted: April 8, 2015
First Posted: April 13, 2015
Results First Submitted: May 24, 2019
Results First Posted: August 13, 2019
Last Update Posted: August 13, 2019