Chronic Kidney DiseasePhase 1/2PRT-201-102NCT01001351
A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease
A Phase 1/2 study testing PRT-201 in people with Chronic Kidney Disease, run by Proteon Therapeutics at 16 sites in United States.
Trial summary
PRT-201 is a recombinant human type-I pancreatic elastase intended for local, long-lasting dilation of the AVG venous anastomosis and outflow vein. The goal of the treatment is to improve primary patency and long-term survival of AVGs and thereby provide patients with chronic kidney disease (CKD) a reliable and… 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
- 89 participants
- Where
- 16 sitesUnited States
- Study dates
- Sep 2009to Nov 2012
- Phase
- Phase 1/2
- 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.
- Chronic kidney disease with anticipated start of hemodialysis within 3 months or current hemodialysis dependence.
- Planned creation of a new upper extremity AVG or "jump" graft
Who cannot join
- Patients for whom this is the only potential site for an upper extremity vascular access.
- Creation of a new AVG or "jump" graft in an upper extremity previously treated with an investigational gene or cell based therapy, or locally with an investigational pharmacological agent.
- On physical examination or by other means, suspected proximal vein stenosis, occlusion, lack of continuity with the subclavian vein, central venous stenosis or central venous occlusion.
- History or presence of an arterial aneurysm.
- Previous treatment with PRT-201.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Vascular Specialty Center
Baton Rouge, Louisiana, 70809
Brigham & Women's Hospital
Boston, Massachusetts, 02115
University of Cincinnati
Cincinnati, Ohio, 45267
Duke University Medical Center
Durham, North Carolina, 27710
Indiana/Ohio Heart
Fort Wayne, Indiana, 46804
Ladenheim Dialysis Access Center
Fresno, California, 93710
Greenville Memorial Hospital
Greenville, South Carolina, 29615
The Methodist Hospital
Houston, Texas, 77030
Indiana University/Purdue University
Indianapolis, Indiana, 46202
University of Louisville
Louisville, Kentucky, 40202
Weill Cornell Medical College
New York, New York, 10065
Sentara Vascular Specialists
Norfolk, Virginia, 23507
Peripheral Vascular Associates
San Antonio, Texas, 78205
California Institute of Renal Research
San Diego, California, 92123
Washington Hospital/Medstar Research
Washington D.C., District of Columbia, 20010
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Graft Creation in Patients With Chronic Kidney Disease
PRT-201 is a recombinant human type-I pancreatic elastase intended for local, long-lasting dilation of the AVG venous anastomosis and outflow vein. The goal of the treatment is to improve primary patency and long-term survival of AVGs and thereby provide patients with chronic kidney disease (CKD) a reliable and durable vascular access site for hemodialysis. Recent data indicate that up to three quarters of patients have loss of graft patency at one year, indicating a substantial need for new therapies. This clinical trial will explore the safety and dilatory effect of topically administered PRT-201 on the outflow vein of a newly placed upper extremity AVG.
- Conditions
- Chronic Kidney Disease
- Being tested
- PRT-201, Placebo
- Keywords
- Chronic Kidney Disease, Arteriovenous Grafts (AVG), Hemodialysis, Vascular Access, Dialysis, Graft, Access, vonapanitase, kidney, renal
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRT-201Drug
Applied topically during surgery.
PlaceboDrug
Applied topically during surgery
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| PRT-201 | Experimental | Not described Receives: Drug: PRT-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of a single topical dose of PRT-201.
Measured: Day of AVG creation and 4 weeks After surgery.
Secondary outcomes (2)
Primary graft patency
Measured: 3, 6, 9 and 12 months after AVG creation.
Secondary graft patency.
Measured: 3, 6, 9 and 12 months after AVG creation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startSep 2009
- 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 (2)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proteon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marco Wong, MD, PhD, Study director, Proteon Therapeutics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001351
- Sponsor's protocol ID
- PRT-201-102
- Acronym
- PRT-201-102
- Status last verified
- Apr 2015
- First submitted
- 22 Oct 2009
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dwivedi AJ, Roy-Chaudhury P, Peden EK, Browne BJ, Ladenheim ED, Scavo VA, Gustafson PN, Wong MD, Magill M, Lindow F, Blair AT, Jaff MR, Franano FN, Burke SK. Application of human type I pancreatic elastase (PRT-201) to the venous anastomosis of arteriovenous grafts in patients with chronic kidney disease. J Vasc Access. 2014 Sep-Oct;15(5):376-84. doi: 10.5301/jva.5000235. Epub 2014 May 3.
PubMed 24811601Mohamed I, Kamarizan MFA, Da Silva A. Medical adjuvant treatment to increase patency of arteriovenous fistulae and grafts. Cochrane Database Syst Rev. 2021 Jul 23;7(7):CD002786. doi: 10.1002/14651858.CD002786.pub4.
PubMed 34298589
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, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Graft Creation in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01001351
- Acronym / sponsor ID
- PRT-201-102 / PRT-201-102
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Arteriovenous Grafts (AVG), Hemodialysis, Vascular Access, Dialysis, Graft, Access, vonapanitase
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Proteon TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 26 Oct 2009 (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.
PRT-201 is a recombinant human type-I pancreatic elastase intended for local, long-lasting dilation of the AVG venous anastomosis and outflow vein. The goal of the treatment is to improve primary patency and long-term survival of AVGs and thereby provide patients with chronic kidney disease (CKD) a reliable and durable vascular access site for hemodialysis. Recent data indicate that up to three quarters of patients have loss of graft patency at one year, indicating a substantial need for new therapies. This clinical trial will explore the safety and dilatory effect of topically administered PRT-201 on the outflow vein of a newly placed upper extremity AVG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| PRT-201 | Experimental | 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 (3 listed)
- Age of at least 18 years.
- Chronic kidney disease with anticipated start of hemodialysis within 3 months or current hemodialysis dependence.
- Planned creation of a new upper extremity AVG or "jump" graft
Key exclusion criteria (5 listed)
- Patients for whom this is the only potential site for an upper extremity vascular access.
- Creation of a new AVG or "jump" graft in an upper extremity previously treated with an investigational gene or cell based therapy, or locally with an investigational pharmacological agent.
- On physical examination or by other means, suspected proximal vein stenosis, occlusion, lack of continuity with the subclavian vein, central venous stenosis or central venous occlusion.
- History or presence of an arterial aneurysm.
- Previous treatment with PRT-201.
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-201Applied topically during surgery. | Drug | PRT-201 |
| PlaceboApplied topically during surgery | Drug | Placebo |
Primary outcome
To assess the safety of a single topical dose of PRT-201.
Time frame: Day of AVG creation and 4 weeks After surgery.
2 secondary outcomes
Primary graft patency
Time frame: 3, 6, 9 and 12 months after AVG creation.
Secondary graft patency.
Time frame: 3, 6, 9 and 12 months after AVG 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 24811601Dwivedi AJ, Roy-Chaudhury P, Peden EK, Browne BJ, Ladenheim ED, Scavo VA, Gustafson PN, Wong MD, Magill M, Lindow F, Blair AT, Jaff MR, Franano FN, Burke SK. Application of human type I pancreatic elastase (PRT-201) to the venous anastomosis of arteriovenous grafts in patients with chronic kidney disease. J Vasc Access. 2014 Sep-Oct;15(5):376-84. doi: 10.5301/jva.5000235. Epub 2014 May 3.
- Derived from this study: PubMed 34298589Mohamed I, Kamarizan MFA, Da Silva A. Medical adjuvant treatment to increase patency of arteriovenous fistulae and grafts. Cochrane Database Syst Rev. 2021 Jul 23;7(7):CD002786. doi: 10.1002/14651858.CD002786.pub4.
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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.
Marco Wong, MD, PhD study director
Proteon Therapeutics, Inc
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PRT-201 in people with Chronic Kidney Disease, run by Proteon Therapeutics at 16 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 3 inclusion and 5 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 16 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To assess the safety of a single topical dose of PRT-201. (time frame: Day of AVG creation and 4 weeks After surgery.). 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 NCT01001351, which also lists 2 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 30 Apr 2015.