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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
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Kim, Yong Chul | - |
dc.contributor.author | Park, Jae Yoon | - |
dc.contributor.author | Oh, Sohee | - |
dc.contributor.author | Cho, Jang-Hee | - |
dc.contributor.author | Chang, Jae Hyun | - |
dc.contributor.author | Choi, Dae Eun | - |
dc.contributor.author | Park, Jung Tak | - |
dc.contributor.author | Lee, Jung Pyo | - |
dc.contributor.author | Kim, Sejoong | - |
dc.contributor.author | Kim, Dong Ki | - |
dc.contributor.author | Ryu, Dong-Ryeol | - |
dc.contributor.author | Lim, Chun Soo | - |
dc.date.accessioned | 2020-03-23T08:30:34Z | - |
dc.date.available | 2020-04-05T17:31:42Z | - |
dc.date.issued | 2019-11-28 | - |
dc.identifier.citation | Trials, 20(1):651 | ko_KR |
dc.identifier.issn | 1745-6215 | - |
dc.identifier.uri | 10.1186/s13063-019-3753-1 | - |
dc.identifier.uri | https://hdl.handle.net/10371/164763 | - |
dc.description.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 Becks 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. | ko_KR |
dc.description.sponsorship | This work was initiated and financially supported by Viromed Co. Ltd., Seoul, Republic of Korea, and Jinyangpharm. Co. Ltd., Seoul, Republic of Korea. The sponsors supported the expenses for the investigational products, laboratory tests, and clinical research coordinator. The funding body had no role in the writing of the manuscript based on the study protocol (Project No.
VM_PG102P). | ko_KR |
dc.language.iso | en | ko_KR |
dc.publisher | BMC | ko_KR |
dc.subject | Uremic pruritus | - |
dc.subject | Hemodialysis | - |
dc.subject | PG201P | - |
dc.title | Safety and efficacy of PG102P for the control of pruritus in patients undergoing hemodialysis (SNUG trial): study protocol for a randomized controlled trial | ko_KR |
dc.type | Article | ko_KR |
dc.contributor.AlternativeAuthor | 김용철 | - |
dc.contributor.AlternativeAuthor | 박재윤 | - |
dc.contributor.AlternativeAuthor | 오소희 | - |
dc.contributor.AlternativeAuthor | 조장희 | - |
dc.contributor.AlternativeAuthor | 장재현 | - |
dc.contributor.AlternativeAuthor | 최대은 | - |
dc.contributor.AlternativeAuthor | 박정탁 | - |
dc.contributor.AlternativeAuthor | 이정표 | - |
dc.contributor.AlternativeAuthor | 김세중 | - |
dc.contributor.AlternativeAuthor | 김동기 | - |
dc.contributor.AlternativeAuthor | 류동렬 | - |
dc.contributor.AlternativeAuthor | 임천수 | - |
dc.citation.journaltitle | Trials | ko_KR |
dc.language.rfc3066 | en | - |
dc.rights.holder | The Author(s). | - |
dc.date.updated | 2019-12-01T04:31:23Z | - |
dc.citation.number | 1 | ko_KR |
dc.citation.startpage | 651 | ko_KR |
dc.citation.volume | 20 | ko_KR |
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