Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Nov 28;20(1):651.
doi: 10.1186/s13063-019-3753-1.

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

Yong Chul Kim  1 , Jae Yoon Park  2 , Sohee Oh  3 , Jang-Hee Cho  4   5 , Jae Hyun Chang  6 , Dae Eun Choi  7 , Jung Tak Park  8 , Jung Pyo Lee  9   10 , Sejoong Kim  11 , Dong Ki Kim  1   10 , Dong-Ryeol Ryu  12   13 , Chun Soo Lim  14   15
Affiliations

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

Yong Chul Kim et al. Trials. .

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.

Keywords: Hemodialysis; PG201P; Uremic pruritus.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart of the SNUG trial
Fig. 2
Fig. 2
Timeline of study procedures and outcome assessments. BDI Beck Depression Inventory, Ca calcium, ECG electrocardiogram, ECP eosinophilic cationic protein, IgE immunoglobulin E, iPTH intact parathyroid hormone, K potassium, KDQoL Kidney Disease Quality of Life, P phosphorus, VAS visual analog scale
See this image and copyright information in PMC

References

    1. Ponticelli C, Bencini PL. Pruritus in dialysis patients: a neglected problem. Nephrol Dial Transplant. 1995;10(12):2174–2176. doi: 10.1093/ndt/10.12.2174. - DOI - PubMed
    1. Schwartz IF, Iaina A. Uraemic pruritus. Nephrol Dial Transplant. 1999;14(4):834–839. doi: 10.1093/ndt/14.4.834. - DOI - PubMed
    1. Pisoni RL, Wikstrom B, Elder SJ, Akizawa T, Asano Y, Keen ML, et al. Pruritus in haemodialysis patients: international results from the Dialysis Outcomes and Practice Patterns Study (DOPPS) Nephrol Dial Transplant. 2006;21(12):3495–3505. doi: 10.1093/ndt/gfl461. - DOI - PubMed
    1. Narita I, Alchi B, Omori K, Sato F, Ajiro J, Saga D, et al. Etiology and prognostic significance of severe uremic pruritus in chronic hemodialysis patients. Kidney Int. 2006;69(9):1626–1632. doi: 10.1038/sj.ki.5000251. - DOI - PubMed
    1. Goicoechea M, de Sequera P, Ochando A, Andrea C, Caramelo C. Uremic pruritus: an unresolved problem in hemodialysis patients. Nephron. 1999;82(1):73–74. doi: 10.1159/000045371. - DOI - PubMed

Publication types

Associated data