Chronic Kidney DiseasePhase 3NCT02414841
A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2)
A Phase 3 study testing Vonapanitase in people with Chronic Kidney Disease, run by Proteon Therapeutics at 41 sites in 2 countries.
Trial summary
This research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Vonapanitase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 696 participants
- Where
- 41 sitesin 2 countries
- Study dates
- Aug 2015to 1 May 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of at least 18 years.
- Life expectancy of at least 6 months.
- Diagnosis of CKD.
- Planned creation of a new radiocephalic AVF (revision of an existing AVF is not eligible).
- Ability to understand and comply with the requirements of the entire study and to communicate with the study team.
- Written informed consent using a document that has been approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
- If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit and be willing to use contraception from the time of the screening visit to 2 weeks following study drug administration. Acceptable methods of birth control include abstinence, barrier methods, hormones, or intra-uterine device.
Who cannot join
- Malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell or squamous cell skin cancer, or any cancer in situ.
- Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study.
- Previous treatment with vonapanitase (PRT-201).
- Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within the previous 90 days prior to signing informed consent.
Trial locations and contacts
41 sites in 2 countries.
41 sites in 2 countries
United States36 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105
Cardiothoracis and Vascular Surgeons
Austin, Texas, 78756
Lake Washington Vascular Center
Bellevue, Washington, 98004
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Henry Ford Hospital
Detroit, Michigan, 48202
Lutheran Hospital Network of Indiana
Fort Wayne, Indiana, 46804
Greenwood Leflore Hospital
Greenwood, Mississippi, 38930
Baylor College of Medicine
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
The University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Saint Luke's Hospital
Kansas City, Missouri, 64111
Knoxville Kidney Center
Knoxville, Tennessee, 37923
VA Loma Linda Healthcare System
Loma Linda, California, 92357
VA Medical Center Long Beach
Long Beach, California, 90822
Keck University Hospital at USC
Los Angeles, California, 90033
University of Louisville
Louisville, Kentucky, 40202
University of Wisconsin School of Medicine and PH
Madison, Wisconsin, 53792
Tulane University
New Orleans, Louisiana, 70112
New York Presbyterian Hospital-Weill Cornell Medical Center
New York, New York, 10065
SC Nephrology and Hypertension Center, Inc.
Orangeburg, South Carolina, 29118
RenalCare Associates, S.C.
Peoria, Illinois, 61603
AKDHC Medical Research Services, LLC
Phoenix, Arizona, 85012
VA Pittsburg Healthcare System
Pittsburgh, Pennsylvania, 15240
Maine Medical Center
Portland, Maine, 04102
Kaiser Permanente
San Diego, California, 92120
California Institute of Renal Research
San Diego, California, 92123
Kaiser Permanente Northern California
San Francisco, California, 94118
Banner University Medical Center Tucson
Tucson, Arizona, 85724
AKDHC Medical Research Services, LLc
Tucson, Arizona, 85745
Wake Forest
Winston-Salem, North Carolina, 27157
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655
Canada5 sites
University of Alberta
Edmonton, Alberta, T6G2B7
London Health Science Center
London, Ontario, N6A 5W9
McGill University Health Centre- Royal Victoria Hospital
Montreal, Quebec, H4A 3J1
University Health Network Toronto General Hospital
Toronto, Ontario, M5G 2C4
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Multicenter, Double Blind, Placebo Controlled Study of Vonapanitase (PRT- 201) Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
This research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. Vonapanitase is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether vonapanitase when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF.
- Conditions
- Chronic Kidney Disease
- Being tested
- Vonapanitase, Placebo
- Keywords
- radiocephalic, arteriovenous fistula, AVF, hemodialysis, PRT-201, vonapanitase, vascular access, kidney, renal, PATENCY-2, secondary patency, fistula abandonment, use for hemodialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonapanitaseDrug
Also called PRT-201
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vonapanitase | Active comparator | Vonapanitase administered at the time of radiocephalic fistula creation Receives: Drug: Vonapanitase |
| Placebo | Placebo comparator | Placebo administered at the time of radiocephalic fistula creation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kaplan-Meier Estimate of Secondary AVF Patency
Kaplan-Meier estimate of median time from AVF creation until AVF abandonment (secondary patency)
Measured: Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year.
Number of Participants With AVF Use for Hemodialysis
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.
Measured: Assessed at up to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2015 (estimated)
- Study startAug 2015
- Primary completionFeb 2018
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 696 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proteon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414841
- Sponsor's protocol ID
- PRT-201-320
- Status last verified
- Jul 2019
- First submitted
- 8 Apr 2015
- Last updated
- 13 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Heindel P, Fitzgibbon JJ, Secemsky EA, Belkin M, Ozaki CK, Hussain MA. Evaluating the effectiveness of systemic heparin during arteriovenous fistula creation by emulating a target trial. Am J Epidemiol. 2025 Mar 4;194(3):651-658. doi: 10.1093/aje/kwae098.
PubMed 38825327Heindel P, Fitzgibbon JJ, Feliz JD, Hentschel DM, Burke SK, Al-Omran M, Bhatt DL, Belkin M, Ozaki CK, Hussain MA. Evaluating national guideline concordance of recurrent interventions after radiocephalic arteriovenous fistula creation. J Vasc Surg. 2023 Apr;77(4):1206-1215.e2. doi: 10.1016/j.jvs.2022.12.017. Epub 2022 Dec 22.
PubMed 36567000Peden EK, Lucas JF 3rd, Browne BJ, Settle SM, Scavo VA, Bleyer AJ, Ozaki CK, Teruya TH, Wilson SE, Mishler RE, Ferris BL, Hendon KS, Moist L, Dixon BS, Wong MD, Magill M, Lindow F, Gustafson P, Burke SK; PATENCY-2 Investigators. PATENCY-2 trial of vonapanitase to promote radiocephalic fistula use for hemodialysis and secondary patency. J Vasc Access. 2022 Mar;23(2):265-274. doi: 10.1177/1129729820985626. Epub 2021 Jan 22.
PubMed 33482699
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double Blind, Placebo Controlled Study of Vonapanitase (PRT- 201) Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02414841
- Acronym / sponsor ID
- PRT-201-320
- Conditions
- Chronic Kidney Disease
- Keywords
- radiocephalic, arteriovenous fistula, AVF, hemodialysis, PRT-201, vonapanitase, vascular access, kidney
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 696 participants (actual)
- Lead sponsor
- Proteon TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 13 Apr 2015 (estimated)
- Results
- Posted 13 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. Vonapanitase is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether vonapanitase when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vonapanitase | Active comparator | Drug: VonapanitaseVonapanitase administered at the time of radiocephalic fistula creation |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered at the time of radiocephalic fistula creation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age of at least 18 years.
- Life expectancy of at least 6 months.
- Diagnosis of CKD.
- Planned creation of a new radiocephalic AVF (revision of an existing AVF is not eligible).
- Ability to understand and comply with the requirements of the entire study and to communicate with the study team.
Key exclusion criteria (4 listed)
- Malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell or squamous cell skin cancer, or any cancer in situ.
- Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study.
- Previous treatment with vonapanitase (PRT-201).
- Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within the previous 90 days prior to signing informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VonapanitaseAlso: PRT-201 | Drug | Vonapanitase |
| Placebo | Drug | Placebo |
Primary outcome
Kaplan-Meier Estimate of Secondary AVF Patency
Time frame: Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year.
Kaplan-Meier estimate of median time from AVF creation until AVF abandonment (secondary patency)
Number of Participants With AVF Use for Hemodialysis
Time frame: Assessed at up to 12 Months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38825327Heindel P, Fitzgibbon JJ, Secemsky EA, Belkin M, Ozaki CK, Hussain MA. Evaluating the effectiveness of systemic heparin during arteriovenous fistula creation by emulating a target trial. Am J Epidemiol. 2025 Mar 4;194(3):651-658. doi: 10.1093/aje/kwae098.
- Derived from this study: PubMed 36567000Heindel P, Fitzgibbon JJ, Feliz JD, Hentschel DM, Burke SK, Al-Omran M, Bhatt DL, Belkin M, Ozaki CK, Hussain MA. Evaluating national guideline concordance of recurrent interventions after radiocephalic arteriovenous fistula creation. J Vasc Surg. 2023 Apr;77(4):1206-1215.e2. doi: 10.1016/j.jvs.2022.12.017. Epub 2022 Dec 22.
- Derived from this study: PubMed 33482699Peden EK, Lucas JF 3rd, Browne BJ, Settle SM, Scavo VA, Bleyer AJ, Ozaki CK, Teruya TH, Wilson SE, Mishler RE, Ferris BL, Hendon KS, Moist L, Dixon BS, Wong MD, Magill M, Lindow F, Gustafson P, Burke SK; PATENCY-2 Investigators. PATENCY-2 trial of vonapanitase to promote radiocephalic fistula use for hemodialysis and secondary patency. J Vasc Access. 2022 Mar;23(2):265-274. doi: 10.1177/1129729820985626. Epub 2021 Jan 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vonapanitase in people with Chronic Kidney Disease, run by Proteon Therapeutics at 41 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kaplan-Meier Estimate of Secondary AVF Patency (time frame: Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02414841, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.