Trial reportThe journal of vascular access
Application of human type I pancreatic elastase (PRT-201) to the venous anastomosis of arteriovenous grafts in patients with chronic kidney disease.
Trial report in The journal of vascular access. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01001351 (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), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.
- Medical adjuvant treatment to increase patency of arteriovenous fistulae and grafts.The Cochrane database of systematic reviews · 2021Pooled it
- Medical adjuvant treatment to increase patency of arteriovenous fistulae and grafts.The Cochrane database of systematic reviews · 2015Pooled it
- Cathepsin G promotes arteriovenous fistula maturation by positively regulating the MMP2/MMP9 pathway.Renal failure · 2024Article
- Building a Scaffold for Arteriovenous Fistula Maturation: Unravelling the Role of the Extracellular Matrix.International journal of molecular sciences · 2023Review
- Challenges and novel therapies for vascular access in haemodialysis.Nature reviews. Nephrology · 2020Review
- Pharmacologic Management of Aneurysms.Circulation research · 2019Review
- Disruptive technological advances in vascular access for dialysis: an overview.Pediatric nephrology (Berlin, Germany) · 2018Review
- Future research directions to improve fistula maturation and reduce access failure.Seminars in vascular surgery · 2016Review
- Biomaterial-Based Approaches to Address Vein Graft and Hemodialysis Access Failures.Macromolecular rapid communications · 2016Review
- Periadventitial drug delivery for the prevention of intimal hyperplasia following open surgery.Journal of controlled release : official journal of the Controlled Release Society · 2016Review
- Recombinant Human Elastase Alters the Compliance of Atherosclerotic Tibial Arteries After Ex Vivo Angioplasty.Journal of cardiovascular pharmacology · 2016Article
- Effects of recombinant human type I pancreatic elastase on human atherosclerotic arteries.Journal of cardiovascular pharmacology · 2014Article
- Molecular Targets for Improving Arteriovenous Fistula Maturation and Patency.Vascular investigation and therapyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo explore the safety and efficacy of PRT-201 applied to the outflow vein of a newly created arteriovenous graft (AVG).
methodsRandomized, double-blind, placebo-controlled, single-dose escalation study of PRT-201 (0.01 to 9 mg) applied to the graft-vein anastomosis and adjacent outflow vein immediately after AVG placement. The primary outcome measure was safety. The efficacy measures were intraoperative increases in outflow vein diameter and blood flow rate, primary unassisted patency, and secondary patency by dose groups (placebo, low, medium, high and All PRT-201).
resultsA total of 89 patients were treated (28 placebo and 61 PRT-201). There were no significant differences in the proportion of placebo and PRT-201 patients reporting adverse events. Intraoperative outflow vein diameter increased 5% (p=0.14) in the placebo group compared with 13% (p=0.01), 15% (p=0.07) and 12% (p<0.001), in the low, medium and high groups, respectively. The comparison between the high and placebo groups was marginally statistically significant (p=0.06). The intraoperative blood flow did not change in the placebo group, and increased in the low, medium and high groups by 19% (p=0.34), 36% (p=0.09) and 46% (p=0.02), respectively. The low group had the longest primary unassisted and secondary patency and the fewest procedures to restore or maintain patency; however, the differences between groups were not statistically significant.
conclusionsPRT-201 was well tolerated and increased AVG intraoperative outflow vein diameter and blood flow. Low dose tended to increase secondary patency and decrease the rate of procedures to restore or maintain patency. Larger studies with these doses will be necessary to confirm these results.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.