Journal article
A Multi-center, Dose-escalation Study of Human type I Pancreatic Elastase (PRT-201) Administered after Arteriovenous Fistula Creation
The journal of vascular access, Vol.14(2), pp.143-151
04/2013
DOI: 10.5301/jva.5000125
PMCID: PMC6159815
PMID: 23172172
Abstract
Purpose To explore the safety and efficacy of PRT-201. Methods Randomized, double-blind, placebo-controlled, single-dose escalation study of PRT-201 (0.0033 to 9 mg) applied after arteriovenous fistula (AVF) creation. Participants were followed for one year. The primary outcome measure was safety. Efficacy measures were the proportion with intra-operative increases in AVF outflow vein diameter or blood flow ≥25% (primary), changes in outflow vein diameter and blood flow, AVF maturation and lumen stenosis by ultrasound criteria and AVF patency. Results The adverse events in the PRT-201 group (n=45) were similar to those in the placebo group (n=21). There were no differences in the proportion with ≥25% increase in vein diameter or blood flow, successful maturation or lumen stenosis. There was no statistically significant difference in primary patency between the dose groups (placebo n=21, Low Dose n=16, Medium Dose n=17 and High Dose n=12). In a subgroup analysis that excluded three participants with early surgical failures, the hazard ratio (HR) for primary patency loss of Low Dose compared with placebo was 0.38 (95% CI 0.10-1.41, P=0.15). In a Cox model, Low Dose (HR 0.27, 95% CI 0.04-0.79, P=0.09), white race (HR 0.17, 95% CI 0.03-0.79, P=0.02), and age <65 years (HR 0.25, CI 0.05-1.15, P=0.08) were associated (P<0.10) with a decreased risk of primary patency loss. Conclusions PRT-201 was not different from placebo for safety or efficacy measures. There was a suggestion for improved AVF primary patency with Low Dose PRT-201 that is now being studied in a larger clinical trial.
Details
- Title: Subtitle
- A Multi-center, Dose-escalation Study of Human type I Pancreatic Elastase (PRT-201) Administered after Arteriovenous Fistula Creation
- Creators
- Eric K Peden - Department of Cardiovascular Surgery, The Methodist Hospital, Houston, TX - USADavid B Leeser - Department of Transplantation, New York-Presbyterian Hospital-Weill Cornell Medical Center, New York, NY - USABradley S Dixon - Department of Medicine, University of Iowa, Iowa City, IA - USAMahmoud T El-Khatib - Department of Medicine, University of Cincinnati, Cincinnati, OH - USAPrabir Roy-Chaudhury - Department of Medicine, University of Cincinnati, Cincinnati, OH - USAJeffrey H Lawson - Department of Surgery, Duke University, Durham, NC - USAMatthew T Menard - Department of Surgery, Brigham and Women's Hospital, Boston, MA - USALaura M Dember - Renal-Electrolyte and Hypertension Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA - USAMarc H Glickman - Eastern Virginia Medical School, Norfolk, VA - USAPamela N Gustafson - Research and Development, Proteon Therapeutics, Waltham, MA - USAAndrew T Blair - Research and Development, Proteon Therapeutics, Waltham, MA - USAMarianne Magill - Natick, MA - USAF. Nicholas Franano - Research and Development, Proteon Therapeutics, Waltham, MA - USASteven K Burke - Research and Development, Proteon Therapeutics, Waltham, MA - USA
- Resource Type
- Journal article
- Publication Details
- The journal of vascular access, Vol.14(2), pp.143-151
- DOI
- 10.5301/jva.5000125
- PMID
- 23172172
- PMCID
- PMC6159815
- NLM abbreviation
- J Vasc Access
- ISSN
- 1129-7298
- eISSN
- 1724-6032
- Language
- English
- Date published
- 04/2013
- Academic Unit
- Nephrology; Internal Medicine
- Record Identifier
- 9984094489202771
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