Safety and efficacy of PG102P for the control of pruritus in patients undergoing hemodialysis (SNUG trial): study protocol for a randomized controlled trial
- 주제(키워드) Uremic pruritus , Hemodialysis , PG201P
- 주제(기타) Medicine, Research & Experimental
- 설명문(일반) [Kim, Yong Chul; Kim, Dong Ki] Seoul Natl Univ Hosp, Dept Internal Med, Seoul, South Korea; [Park, Jae Yoon] Dongguk Univ, Dept Internal Med, Ilsan Hosp, Gyeonggi Do, South Korea; [Oh, Sohee] Seoul Natl Univ, Dept Biostat, Boramae Med Ctr, Seoul, South Korea; [Cho, Jang-Hee] Kyungpook Natl Univ, Dept Internal Med, Sch Med, Daegu, South Korea; [Cho, Jang-Hee] Kyungpook Natl Univ Hosp, Dept Internal Med, Div Nephrol, Daegu, South Korea; [Chang, Jae Hyun] Gachon Univ, Dept Internal Med, Gil Med Ctr, Incheon, South Korea; [Choi, Dae Eun] Chungnam Natl Univ, Sch Med, Dept Nephrol, Daejeon, South Korea; [Park, Jung Tak] Yonsei Univ, Coll Med, Inst Kidney Dis Res, Dept Internal Med, Seoul, South Korea; [Lee, Jung Pyo; Lim, Chun Soo] Seoul Natl Univ, Dept Internal Med, Boramae Med Ctr, 20 Boramae Ro 5 Gil, Seoul 07061, South Korea; [Lee, Jung Pyo; Kim, Dong Ki; Lim, Chun Soo] Seoul Natl Univ, Dept Internal Med, Coll Med, Seoul, South Korea; [Kim, Sejoong] Seoul Natl Univ, Dept Internal Med, Bundang Hosp, Seongnam, South Korea; [Ryu, Dong-Ryeol] Ewha Womans Univ, Sch Med, Dept Internal Med, Seoul, South Korea; [Ryu, Dong-Ryeol] Ewha Womans Univ, Tissue Injury Def Res Ctr, Seoul, South Korea
- 등재 SCIE, SCOPUS
- OA유형 Green Published, gold
- 발행기관 BMC
- 발행년도 2019
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000166064
- 본문언어 영어
- Published As http://dx.doi.org/10.1186/s13063-019-3753-1
- PubMed https://pubmed.ncbi.nlm.nih.gov/31779697
초록/요약
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.
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