A Phase 1, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study of Vonapanitase Administered Following Angioplasty of a Distal Popliteal, Tibial or Peroneal Artery in Patients With Peripheral Artery Disease

The research study is designed to assess the technical feasibility and safety of a perivascular injection of vonapanitase delivered via micro-infusion catheter to the distal popliteal, tibial or peroneal arteries immediately following successful angioplasty.

开始日期2016-11-01

申办/合作机构

Proteon Therapeutics, Inc.

NCT02414841 / Completed临床3期

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.

开始日期2015-08-01

申办/合作机构

Proteon Therapeutics, Inc.

NCT02110901 / Completed临床3期

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.

开始日期2014-07-01

申办/合作机构

Proteon Therapeutics, Inc.

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项与 Proteon Therapeutics, Inc. 相关的文献（医药）

2018-07-01·American journal of kidney diseases : the official journal of the National Kidney Foundation1区 · 医学

Medicare Costs Associated With Arteriovenous Fistulas Among US Hemodialysis Patients

1区 · 医学

Article

作者: Pflederer, Timothy A ; Thamer, Mae ; Wasse, Haimanot ; Lee, Timmy C ; Gottlieb, Daniel ; Qian, Joyce ; Glickman, Marc H ; Toner, Scott

BACKGROUND:

An arteriovenous fistula (AVF) is the recommended vascular access for hemodialysis (HD). Previous studies have not examined the resources and costs associated with creating and maintaining AVFs.

STUDY DESIGN:

Retrospective observational study.

SETTING & PARTICIPANTS:

Elderly US Medicare patients initiating hemodialysis therapy during 2010 to 2011.

PREDICTOR:

AVF primary and secondary patency and nonuse in the first year following AVF creation.

OUTCOMES:

Annualized vascular access costs per patient per year.

RESULTS:

Among patients with only a catheter at HD therapy initiation, only 54% of AVFs were successfully used for HD, 10% were used but experienced secondary patency loss within 1 year of creation, and 83% experienced primary patency loss within 1 year of creation. Mean vascular access costs per patient per year in the 2.5 years after AVF creation were $7,871 for AVFs that maintained primary patency in year 1, $13,282 for AVFs that experienced primary patency loss in year 1, $17,808 for AVFs that experienced secondary patency loss in year 1, and $31,630 for AVFs that were not used. Similar patterns were seen among patients with a mature AVF at HD therapy initiation and patients with a catheter and maturing AVF at HD therapy initiation. Overall, in 2013, fee-for-service Medicare paid $2.8 billion for dialysis vascular access-related services, ∼12% of all end-stage renal disease payments.

LIMITATIONS:

Lack of granularity with certain billing codes.

CONCLUSIONS:

AVF failure in the first year after creation is common and results in substantially higher health care costs. Compared with patients whose AVFs maintained primary patency, vascular access costs were 2 to 3 times higher for patients whose AVFs experienced primary or secondary patency loss and 4 times higher for patients who never used their AVFs. There is a need to improve AVF outcomes and reduce costs after AVF creation.

2017-04-01·Journal of vascular surgery2区 · 医学

Arteriovenous fistula patency in the 3 years following vonapanitase and placebo treatment

2区 · 医学

Article

作者: Jensik, Stephen C ; Peden, Eric K ; Browne, Barry J ; Schanzer, Andres S ; Dixon, Bradley S ; Sam, Albert D ; O'Connor, Timothy P ; Burke, Steven K

OBJECTIVE:

This study explored the long-term outcomes of arteriovenous fistulas treated with vonapanitase (recombinant human elastase) at the time of surgical creation.

METHODS:

This was a randomized, double-blind, placebo-controlled trial of 151 patients undergoing radiocephalic or brachiocephalic arteriovenous fistula creation who were randomized equally to placebo, vonapanitase 10 μg, or vonapanitase 30 μg. The results after 1 year of follow-up were previously reported. The current analysis occurred when the last patient treated was observed for 3 years. For the current analysis, the primary end point was primary patency; the secondary end points included secondary patency, use of the fistula for hemodialysis, and rate of procedures to restore or to maintain patency.

RESULTS:

There was no significant difference in the risk of primary patency loss with vonapanitase 10 μg or 30 μg vs placebo. When seven initial patency loss events related to cephalic arch and central vein balloon angioplasty were excluded, the risk of patency loss was reduced with vonapanitase overall (hazard ratio [HR], 0.63; P = .049) and 30 μg (HR, 0.51; P = .03). In patients with radiocephalic fistulas (n = 67), the risks of primary and secondary patency loss were reduced with 30 μg (HR, 0.37 [P = .02] and 0.24 [P = .046], respectively). The rate of procedures to restore or to maintain fistula patency was reduced with 30 μg vs placebo (0.23 vs 0.72 procedure days/patient/year; P = .03) and also reduced in patients with radiocephalic fistulas with 30 μg vs placebo (0.17 vs 0.85 procedure days/patient/year; P = .048).

CONCLUSIONS:

In this study, vonapanitase did not significantly improve primary patency in the primary analysis but did significantly improve primary patency in an analysis that excluded patency loss due to cephalic arch and central vein balloon angioplasty. In patients with radiocephalic fistulas, 30 μg significantly improved primary and secondary patency. Vonapanitase 30 μg decreased the rate of procedures to restore or to maintain patency in the analysis that included all patients and in the subset with radiocephalic fistulas.

2016-04-01·Journal of cardiovascular pharmacology4区 · 医学

Recombinant Human Elastase Alters the Compliance of Atherosclerotic Tibial Arteries After Ex Vivo Angioplasty

4区 · 医学

Article

作者: Bland, Kimberly S. ; Moss, Emma ; Franano, F. Nicholas ; Bingham, Karen ; Wong, Marco D. ; Gottlieb, Daniel P. ; Burke, Steven K.

PURPOSE:

This study was designed to determine whether vonapanitase (formerly PRT-201), a recombinant human elastase, treatment can fragment the protein elastin in elastic fibers and cause dilation of atherosclerotic human peripheral arteries subjected to ex vivo balloon angioplasty.

MATERIALS AND METHODS:

Seven patients undergoing lower limb amputation for peripheral artery disease or who died and donated their bodies to science donated 11 tibial arteries (5 anterior, 6 posterior) for this study. All arteries were atherosclerotic by visual inspection. The arteries underwent ex vivo balloon angioplasty and thereafter were cut into rings and studied on wire myographs where the rings were stretched and tension was recorded. After treatment with vonapanitase 2 mg/mL or vehicle control, myography was repeated and the rings were then subject to elastin content measurement using a desmosine radioimmunoassay and elastic fiber visualization by histology. The wire myography data were used to derive compliance, stress-strain, and incremental elastic modulus curves.

RESULTS:

Vonapanitase treatment reduced elastin (desmosine) content by 60% and decreased elastic fiber histologic staining. Vonapanitase-treated rings experienced less tension at any level of stretch and as a result had shifts in the compliance and stress-strain curves relative to vehicle-treated rings. Vonapanitase treatment did not alter the incremental elastic modulus curve.

CONCLUSIONS:

Vonapanitase treatment of atherosclerotic human peripheral arteries after ex vivo balloon angioplasty fragmented elastin in elastic fibers, decreased tension in the rings at any level of stretch, and altered the compliance and stress-strain curves in a manner predicting arterial dilation in vivo. Based on this result, local treatment of balloon angioplasty sites may increase blood vessel diameter and thereby improve the success of balloon angioplasty in peripheral artery disease.

项与 Proteon Therapeutics, Inc. 相关的新闻（医药）

2024-03-02

·PRNewswire

Global Peripheral Arterial Disease (PAD) Therapeutics Report 2024: Market to Reach $7 Billion by 2030 with Peripheral Stents Accounting for $1.7 Billion

DUBLIN, March 1, 2024 /PRNewswire/ -- The "Peripheral Arterial Disease (PAD) Therapeutics: Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering. Global Peripheral Arterial Disease (PAD) Therapeutics Market to Reach $7 Billion by 2030 The global market for Peripheral Arterial Disease (PAD) Therapeutics estimated at US$4 Billion in the year 2022, is projected to reach a revised size of US$7 Billion by 2030, growing at a CAGR of 7.1% over the analysis period 2022-2030. Peripheral Stents, one of the segments analyzed in the report, is projected to record a 6.9% CAGR and reach US$1.7 Billion by the end of the analysis period. Taking into account the ongoing post pandemic recovery, growth in the Peripheral Angioplasty Balloons segment is readjusted to a revised 6.4% CAGR for the next 8-year period. The U.S. Market is Estimated at $1.2 Billion, While China is Forecast to Grow at 6.7% CAGR The Peripheral Arterial Disease (PAD) Therapeutics market in the U.S. is estimated at US$1.2 Billion in the year 2022. China, the world's second largest economy, is forecast to reach a projected market size of US$1.2 Billion by the year 2030 trailing a CAGR of 6.7% over the analysis period 2022 to 2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 6.3% and 5.9% respectively over the 2022-2030 period. Within Europe, Germany is forecast to grow at approximately 5.5% CAGR. MARKET OVERVIEW Influencer Market Insights World Market Trajectories PAD - A Prelude Recent Market Activity PAD Statistics Critical Limb Ischemia - An Insight High Costs - A Cause of Concern Peripheral Arterial Disease (PAD) Therapeutics - Global Key Competitors Percentage Market Share in 2022 (E) Impact of Covid-19 and a Looming Global Recession Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2022 (E) MARKET TRENDS & DRIVERS Aging - A Key Driver High Diabetes Incidence Worldwide: Key Market Opportunity for PAD Therapeutics FOCUS ON SELECT PLAYERS (Total 32 Featured) AstraZeneca Plc. (UK) Bayer HealthCare Pharmaceuticals (Germany) Bristol-Myers Squibb Company (US) Merck & Co., Inc. (US) Proteon Therapeutics, Inc. (US) Sanofi S.A. (France) Symic Bio, Inc. (US) TheraVasc Inc. (US) For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

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