Chronic Kidney DiseasePhase 1/2NCT00679991
A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients
A Phase 1/2 study testing PRT-201 in people with Chronic Kidney Disease, run by Proteon Therapeutics at 11 sites in United States.
Trial summary
PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel. The purpose of this study is to determine if PRT-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (AVF), is safe, dilates… 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
- 66 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 2008to Jul 2011
- 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 six months or current hemodialysis dependence.
- Planned creation of a new AVF.
Who cannot join
- Patients for whom this is the only potential site for an AVF.
- By physical examination, absence of radial or ulnar artery flow or non-patent palmer arch.
- Treatment with any investigational agent within the previous 30 days or investigational antibody therapy within 90 days of signing informed consent.
- Pregnancy, lactation or plans to become pregnant during the course of the study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Duke University Medical Center
Durham, North Carolina, 27710
The Methodist Hospital
Houston, Texas, 77030
Clarian Health Partners/Indiana University/Purdue University
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Weill Cornell Medical College
New York, New York, 10065
Sentara Medical Group
Norfolk, Virginia, 23507
Maine Medical Center
Portland, Maine, 04102
Western New England Renal & Transplant Associates
Springfield, Massachusetts, 01104
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: A Phase 1-2, Multi-Center, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel. The purpose of this study is to determine if PRT-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow through the AVF.
- Conditions
- Chronic Kidney Disease
- Being tested
- PRT-201
- Keywords
- arteriovenous fistula, AVF, hemodialysis, vascular access, PRT 201, dose escalation, dialysis, fistula, access, 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
Applied topically to AVF during surgery
PRT-201Drug
Dose escalation study. Drug/placebo administered at the time of fistula creation
| Study group | Role | What they receive |
|---|---|---|
| PRT-201 | Active comparator | Not described Receives: Drug: PRT-201 |
| 2 | Placebo comparator | 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. To assess the effect on the diameter of and blood flow through the AVF outflow vein.
Measured: 2 & 6 weeks after AVF creation
Secondary outcomes (1)
The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis.
Measured: 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startNov 2008
- Primary completionJul 2011
- Study completionJul 2011
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 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
- NCT00679991
- Sponsor's protocol ID
- PRT-201-101
- Status last verified
- Apr 2015
- First submitted
- 15 May 2008
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Peden EK, Leeser DB, Dixon BS, El-Khatib MT, Roy-Chaudhury P, Lawson JH, Menard MT, Dember LM, Glickman MH, Gustafson PN, Blair AT, Magill M, Franano FN, Burke SK. A multi-center, dose-escalation study of human type I pancreatic elastase (PRT-201) administered after arteriovenous fistula creation. J Vasc Access. 2013 Apr-Jun;14(2):143-51. doi: 10.5301/jva.5000125. Epub 2012 Nov 20.
PubMed 23172172
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
- A Phase 1-2, Multi-Center, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00679991
- Acronym / sponsor ID
- PRT-201-101
- Conditions
- Chronic Kidney Disease
- Keywords
- arteriovenous fistula, AVF, hemodialysis, vascular access, PRT 201, dose escalation, dialysis, fistula
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Proteon TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 19 May 2008 (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 protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel. The purpose of this study is to determine if PRT-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow through the AVF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRT-201 | Active comparator | Drug: PRT-201 |
| 2 | Placebo 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 (3 listed)
- Age of at least 18 years.
- Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence.
- Planned creation of a new AVF.
Key exclusion criteria (4 listed)
- Patients for whom this is the only potential site for an AVF.
- By physical examination, absence of radial or ulnar artery flow or non-patent palmer arch.
- Treatment with any investigational agent within the previous 30 days or investigational antibody therapy within 90 days of signing informed consent.
- Pregnancy, lactation or plans to become pregnant during the course of the study.
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 to AVF during surgery | Drug | PRT-201 |
| PRT-201Dose escalation study. Drug/placebo administered at the time of fistula creation | Drug | 2, PRT-201 |
Primary outcome
To assess the safety of a single topical dose of PRT-201. To assess the effect on the diameter of and blood flow through the AVF outflow vein.
Time frame: 2 & 6 weeks after AVF creation
1 secondary outcome
The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis.
Time frame: 3, 6, 9, and 12 months
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 23172172Peden EK, Leeser DB, Dixon BS, El-Khatib MT, Roy-Chaudhury P, Lawson JH, Menard MT, Dember LM, Glickman MH, Gustafson PN, Blair AT, Magill M, Franano FN, Burke SK. A multi-center, dose-escalation study of human type I pancreatic elastase (PRT-201) administered after arteriovenous fistula creation. J Vasc Access. 2013 Apr-Jun;14(2):143-51. doi: 10.5301/jva.5000125. Epub 2012 Nov 20.
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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.
11 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 11 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 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 11 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. To assess the effect on the diameter of and blood flow through the AVF outflow vein. (time frame: 2 & 6 weeks after AVF creation). 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 NCT00679991, 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.