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Safety and efficacy of PG102P for the control of pruritus in patients undergoing hemodialysis (SNUG trial): study protocol for a randomized controlled trial

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Authors
Kim, Yong Chul; Park, Jae Yoon; Oh, Sohee; Cho, Jang-Hee; Chang, Jae Hyun; Choi, Dae Eun; Park, Jung Tak; Lee, Jung Pyo; Kim, Sejoong; Kim, Dong Ki; Ryu, Dong-Ryeol; Lim, Chun Soo
Issue Date
2019-11-28
Publisher
BMC
Citation
Trials, 20(1):651
Keywords
Uremic pruritusHemodialysisPG201P
Abstract
Background
Pruritus in patients undergoing hemodialysis is a highly prevalent complication that affects quality of life. Several medications are currently used for the treatment of uremic pruritus, but these are not satisfactory. PG102P, which is prepared from Actinidia arguta, has an immune-modulating effect on pruritus. This trial is designed to assess the antipruritic effect of PG102P compared with placebo.

Methods
This multicenter, randomized, double-blind, placebo-controlled clinical trial will include 80 patients undergoing hemodialysis. The patients will be randomized in a 1:1 ratio to a treatment group (PG102P 1.5 g/day) or a control group (placebo). The treatment will last for 8 weeks, followed by a 2-week observational period. During the observational period, all of the patients will maintain the antipruritic treatment previously used. The primary endpoint will be measured as the difference in visual analog scale between the groups before and after treatment. Secondary outcomes include serum levels of total immunoglobulin E, eosinophil cationic protein, potassium, calcium, phosphorus, intact parathyroid hormone, and blood eosinophil count between weeks 0 and 8. Kidney Disease and Quality of Life and Beck’s Depression Inventory questionnaires will be conducted. Safety assessments and any adverse events that occur will also be evaluated.

Discussion
The SNUG is a clinical study that aims to investigate the antipruritic effect of PG102P to ameliorate itching in patients undergoing hemodialysis.

Trial registration
Clinical Trials.gov, NCT03576235. Registered on 4 July 2018.
ISSN
1745-6215
Language
English
URI
https://doi.org/10.1186/s13063-019-3753-1

http://hdl.handle.net/10371/164763
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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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