Chronic Kidney DiseasePhase 2NCT01305824
A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
A Phase 2 study testing PRT-201 in people with Chronic Kidney Disease, run by Proteon Therapeutics at 23 sites in United States.
Trial summary
The purpose of this study is to determine if PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous fistula is safe and improves the patency of your fistula. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 151 participants
- Where
- 23 sitesUnited States
- Study dates
- Mar 2011to Nov 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- 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.
- Chronic kidney disease on hemodialysis, or with anticipated start of hemodialysis within 6 months.
- Planned creation of a new radiocephalic or brachiocephalic AVF. Revisions of an existing AVF and transposed AVF are not acceptable.
Who cannot join
- History or presence of an arterial aneurysm.
- 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 cancer, squamous cell skin cancer, or any cancer in situ.
- Hepatic dysfunction defined as bilirubin, ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal, decompensated cirrhosis, ascites, or known esophageal or gastric varices.
- Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Lehigh Valley Hospital
Allentown, Pennsylvania
Vascular Specialty Center
Baton Rouge, Louisiana
Beth Israel Deconness Hospital
Boston, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts
Rush Medical Center
Chicago, Illinois
St Clair Specialty Physicians
Detroit, Michigan
Duke University Medical Center
Durham, North Carolina, 27710
Indiana Ohio Heart
Fort Wayne, Indiana
The Methodist Hospital
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan
University of Louisville
Louisville, Kentucky
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Weill Cornell Medical College
New York, New York, 10065
Sentara Medical Group
Norfolk, Virginia, 23507
Renal Care Associates
Peoria, Illinois
Legacy Oregon Surgical
Portland, Oregon
California Institute of Renal Research
San Diego, California, 92123
Kaiser Permanente
San Diego, California
UCSF
San Francisco, California
Montefiore Medical Center
The Bronx, New York
UMASS Medical Center
Worcester, Massachusetts
About this study
Official title: Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
The purpose of this study is to determine if PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous fistula is safe and improves the patency of your fistula. PRT-201 is a protein that has been shown to help keep vessels open ("patent") when applied to the outside surface of the blood vessels (arteries and veins) in AVF patients in a previous study.
- Conditions
- Chronic Kidney Disease
- Being tested
- PRT-201, Placebo
- Keywords
- arteriovenous fistula, AVF, hemodialysis, vascular access, dialysis, fistula, PRT-201, vonapanitase, kidney, renal
- Medical subject headings
- Renal Insufficiency, Chronic, Arteriovenous Fistula, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRT-201Drug
PRT-201 10 micrograms administered at the time of AVF creation.
PlaceboDrug
Placebo administered at the time of AVF creation.
PRT-201Drug
PRT-201 30 micrograms administered at the time of AVF creation.
| Study group | Role | What they receive |
|---|---|---|
| PRT 201 (10 micrograms) | Active comparator | Not described Receives: Drug: PRT-201 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| PRT-201 (30 micrograms) | Active comparator | Not described Receives: Drug: PRT-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary AVF patency.
Measured: 12 months after AVF creation
Number of participants with adverse events as a measure of safety and tolerability of PRT-201.
Measured: 12 months after AVF creation.
Secondary outcomes (1)
Secondary Fistula Patency
Measured: 12 months after AVF creation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 151 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
- NCT01305824
- Sponsor's protocol ID
- PRT-201-201
- Status last verified
- Apr 2015
- First submitted
- 16 Feb 2011
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hye RJ, Peden EK, O'Connor TP, Browne BJ, Dixon BS, Schanzer AS, Jensik SC, Dember LM, Jaff MR, Burke SK. Human type I pancreatic elastase treatment of arteriovenous fistulas in patients with chronic kidney disease. J Vasc Surg. 2014 Aug;60(2):454-461.e1. doi: 10.1016/j.jvs.2014.02.037. Epub 2014 Mar 27.
PubMed 24684771
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. 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 Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01305824
- Acronym / sponsor ID
- PRT-201-201
- Conditions
- Chronic Kidney Disease
- Keywords
- arteriovenous fistula, AVF, hemodialysis, vascular access, dialysis, fistula, PRT-201, vonapanitase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Proteon TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 1 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous fistula is safe and improves the patency of your fistula. PRT-201 is a protein that has been shown to help keep vessels open ("patent") when applied to the outside surface of the blood vessels (arteries and veins) in AVF patients in a previous study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRT 201 (10 micrograms) | Active comparator | Drug: PRT-201 |
| Placebo | Placebo comparator | Drug: Placebo |
| PRT-201 (30 micrograms) | Active comparator | Drug: PRT-201 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of at least 18 years.
- Life expectancy of at least 6 months.
- Chronic kidney disease on hemodialysis, or with anticipated start of hemodialysis within 6 months.
- Planned creation of a new radiocephalic or brachiocephalic AVF. Revisions of an existing AVF and transposed AVF are not acceptable.
Key exclusion criteria (4 listed)
- History or presence of an arterial aneurysm.
- 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 cancer, squamous cell skin cancer, or any cancer in situ.
- Hepatic dysfunction defined as bilirubin, ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal, decompensated cirrhosis, ascites, or known esophageal or gastric varices.
- Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 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-201PRT-201 10 micrograms administered at the time of AVF creation. | Drug | PRT 201 (10 micrograms) |
| PlaceboPlacebo administered at the time of AVF creation. | Drug | Placebo |
| PRT-201PRT-201 30 micrograms administered at the time of AVF creation. | Drug | PRT-201 (30 micrograms) |
Primary outcome
Primary AVF patency.
Time frame: 12 months after AVF creation
Number of participants with adverse events as a measure of safety and tolerability of PRT-201.
Time frame: 12 months after AVF creation.
1 secondary outcome
Secondary Fistula Patency
Time frame: 12 months after AVF creation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Results publication: PubMed 24684771Hye RJ, Peden EK, O'Connor TP, Browne BJ, Dixon BS, Schanzer AS, Jensik SC, Dember LM, Jaff MR, Burke SK. Human type I pancreatic elastase treatment of arteriovenous fistulas in patients with chronic kidney disease. J Vasc Surg. 2014 Aug;60(2):454-461.e1. doi: 10.1016/j.jvs.2014.02.037. Epub 2014 Mar 27.
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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.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRT-201 in people with Chronic Kidney Disease, run by Proteon Therapeutics at 23 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 4 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 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary AVF patency. (time frame: 12 months after AVF creation). 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 NCT01305824, which also lists 1 linked publication.
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 30 Apr 2015.