Chronic Kidney DiseasePhase 3NCT02110901
A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)
A Phase 3 study testing PRT-201 in people with Chronic Kidney Disease, run by Proteon Therapeutics at 35 sites in United States.
Trial summary
This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients both receiving or expecting to receive dialysis 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?
- PRT-201
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 349 participants
- Where
- 35 sitesUnited States
- Study dates
- Jul 2014to Dec 2018
- 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 Chronic Kidney Disease (CKD).
- Planned creation of a new radiocephalic arteriovenous fistula (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).
- If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit (Visit 1) 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 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
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
University of Maryland
Baltimore, Maryland, 21201
Lake Washington Vascular Center
Bellevue, Washington, 98004
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Brigham and Women's Hospital
Boston, Massachusetts, 02482
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Rush Medical Center
Chicago, Illinois, 60612
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
University of Cincinnati
Cincinnati, Ohio, 45267
Ohio State University
Columbus, Ohio, 43210
Duke University
Durham, North Carolina, 27710
University of Maryland Shore Medical Center at Easton
Easton, Maryland, 21601
Lutheran Hospital Network of Indiana
Fort Wayne, Indiana, 46804
The Methodist Hospital
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Alliance Research Center
Laguna Hills, California, 92653
VA Medical Center Long Beach
Long Beach, California, 90822
Keck University Hospital at USC
Los Angeles, California, 90033
University of Louisville
Louisville, Kentucky, 40202
Tulane University
New Orleans, Louisiana, 70112
Mount Sinai Medical Center
New York, New York, 10029
Renal Care Associates
Peoria, Illinois, 61603
AKDHC Medical Research Services , LLC
Phoenix, Arizona, 85012
VA Pittsburg Healthcare System
Pittsburgh, Pennsylvania, 15240
Maine Medical Center
Portland, Maine, 04102
W.G. Hefner VA Medical Center
Salisbury, North Carolina, 28144
Kaiser Permanente Medical Center
San Diego, California, 92120
California Institute of Renal Research
San Diego, California, 92123
UCSF Division of Vascular & Endovascular Surgery
San Francisco, California, 94143
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71130
AKDHC Medical Research Services, LLc
Tucson, Arizona, 85719
The University of Oklahoma College of Medicine
Tulsa, Oklahoma, 74104
Wake Forest
Winston-Salem, North Carolina, 27157
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: Multicenter, Double-Blind, Placebo-Controlled Study of 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 PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 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 PRT-201 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
- PRT-201, Placebo
- Keywords
- radiocephalic, arteriovenous fistula, AVF, hemodialysis, PRT-201, vascular access, kidney, renal, vonapanitase, PATENCY-1
- 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.
PRT-201Drug
Also called vonapanitase
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| PRT-201 | Active comparator | PRT-201 administered at the time of radiocephalic fistula creation Receives: Drug: PRT-201 |
| Placebo | Placebo comparator | Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition to PRT-201 but lacks the active ingredient. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to AVF Primary Unassisted Patency
Primary unassisted patency defined as the time from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency.
Measured: Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency, assessed up to 1 year
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 until AVF abandonment (secondary patency), assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2016
- Study completionDec 2018
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
- 349 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
- NCT02110901
- Sponsor's protocol ID
- PRT-201-310
- Status last verified
- Jun 2019
- First submitted
- 2 Apr 2014
- Last updated
- 9 Jul 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 36567000Bleyer AJ, Scavo VA, Wilson SE, Browne BJ, Ferris BL, Ozaki CK, Lee T, Peden EK, Dixon BS, Mishler R, O'Connor TP, Kidd K, Burke SK; PATENCY-1 Investigators. A randomized trial of vonapanitase (PATENCY-1) to promote radiocephalic fistula patency and use for hemodialysis. J Vasc Surg. 2019 Feb;69(2):507-515. doi: 10.1016/j.jvs.2018.04.068.
PubMed 30683197
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02110901
- Acronym / sponsor ID
- PRT-201-310
- Conditions
- Chronic Kidney Disease
- Keywords
- radiocephalic, arteriovenous fistula, AVF, hemodialysis, PRT-201, vascular access, kidney, renal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Proteon TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Posted 9 Jul 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 PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 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 PRT-201 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 |
|---|---|---|
| PRT-201 | Active comparator | Drug: PRT-201PRT-201 administered at the time of radiocephalic fistula creation |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition to PRT-201 but lacks the active ingredient. |
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 Chronic Kidney Disease (CKD).
- Planned creation of a new radiocephalic arteriovenous fistula (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 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 |
|---|---|---|
| PRT-201Also: vonapanitase | Drug | PRT-201 |
| Placebo | Drug | Placebo |
Primary outcome
Time to AVF Primary Unassisted Patency
Time frame: Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency, assessed up to 1 year
Primary unassisted patency defined as the time from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency.
Kaplan-Meier Estimate of Secondary AVF Patency
Time frame: Median time from AVF creation until AVF abandonment (secondary patency), assessed up to 1 year
Kaplan-Meier Estimate of median time from AVF creation until AVF abandonment (secondary patency)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 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 30683197Bleyer AJ, Scavo VA, Wilson SE, Browne BJ, Ferris BL, Ozaki CK, Lee T, Peden EK, Dixon BS, Mishler R, O'Connor TP, Kidd K, Burke SK; PATENCY-1 Investigators. A randomized trial of vonapanitase (PATENCY-1) to promote radiocephalic fistula patency and use for hemodialysis. J Vasc Surg. 2019 Feb;69(2):507-515. doi: 10.1016/j.jvs.2018.04.068.
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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.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PRT-201 in people with Chronic Kidney Disease, run by Proteon Therapeutics at 35 sites in United States.
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 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. 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 9 Jul 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?
Time to AVF Primary Unassisted Patency (time frame: Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain 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 NCT02110901, 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 9 Jul 2019.