Safety and Efficacy of PG102P for Uremic Pruritus in HD Patients (SNUG)

Safety and Efficacy of PG102P for the coNtrol of prUritus in Patients underGoing Hemodialysis (SNUG Trial): Study Protocol for a Randomized Control Trial

In this study (SNUG trial), the investigators aim to investigate the anti-pruritic effect of PG102P in comparison with placebo in 80 patients undergoing HD.

Study Overview

• Status: Completed
• Conditions: Uremic Pruritus
• Intervention / Treatment: Drug: PG102P; Drug: Placebo

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled trial in which one group will be treated with PG102P (1.5 g/day) and the other with a placebo. It is an investigator-initiated clinical trial. A superiority trial is planned to test the hypothesis that PG102P is effective in relieving pruritus for patients with ESRD undergoing HD.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 07061
    • Seoul National University Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age over 19 years
2. Patients with adequate HD (Kt/V > 1.2)
3. Maintenance patients undergoing HD with chronic pruritus
4. Mean visual analog scale (VAS) over 4 of the last 5 days in the 14-day pre-observation period
5. Participants who allowed to continue the anti-pruritic drug treatment at the same dosage and administration schedule as used at baseline throughout the study period
6. Patients who agreed to participate in this trial and had written an informed consent

Exclusion Criteria:

1. Intact parathyroid hormone (iPTH) > 1000 pg/mL within 1 month
2. Serum potassium > 7.0 mg/dL
3. HIV Ab (+)
4. Aspartate transaminase (AST) (glutamic oxaloacetic transaminase) or alanine transaminase (ALT) (glutamic pyruvic transaminase) > 3 times the upper limit of normal
5. Scheduled to have kidney transplantation within 3 months
6. Cancer history with current treatment
7. Active infection with current treatment
8. Current itching with dermatologic diseases other than uremic pruritus
9. Pregnancy, childbearing potential during the study period, or breastfeeding
10. Allergy or hypersensitivity reaction to PG102P
11. History of participating another clinical trial within 2 months or planning to participate another clinical trial
12. Not eligible to participate this trial as researchers' decision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: a treatment group; PG102P 1.5 g/day	Drug: PG102P; Daily dose of 1.5g
PLACEBO_COMPARATOR: a control group; placebo	Drug: Placebo; Daily dose of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS change from baseline	The primary endpoint is the change in VAS	the change in VAS between visit 2 (week 0) and visits 3, 4, 5, and 6 (weeks 2, 4, 8, 10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum total IgE	immunoglobulin E	week 0, week 8
blood Eosinophil count	Eosinophil count	week 0, week 8
serum ECP	Eosinophil Cationic Protein	week 0, week 8
serum Ca	serum Calcium	week 0, week 8
serum P	serum Phosphorus,	week 0, week 8
serum K	serum Potassium	week 0, week 8
serum iPTH	intact parathyroid hormone	week 0, week 8
Questionnaire #1 (KDQOL, Kidney Disease and Quality of Life)	The KDQOL-SF 1.3 includes 43 kidney disease targeted items as well as 36 items that provide a generic core and a overall health rating items (SF-36). The lowest and highest scores of each items are set at 0 to 100, with higher scores reflecting better quality of life.; Kidney disease targeted (number of items)Symptoms/Problems (12), Effects of kidney disease (8), Burden of kidney disease (4), Work status (2), Cognitive function (3), Quality of social interaction (3), Sexual function (2), Sleep (4), Social support (2), Dialysis staff encouragement (2), Patient satisfaction rating (1), Overall heath rating (1); SF-36 (number of items) Physical functioning (10), Role-physical (4), Bodily pain (2), General health (5), Mental health (5), Role-emotional (3), Social functioning (2), Vitality (4)	week 0, week 8
Questionnaire #2 (BDI, Beck's Depression Inventory)	The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Each answer is scored 0-3 with a maximum score of 63 points, and higher total scores indicate more severe depressive symptoms. 0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, 29-63: severe depression.	week 0, week 8
serum IL-31	inflammatory cytokine	week 0, week 8

Collaborators and Investigators

• Sponsor: Seoul National University Boramae Hospital
• Collaborators: Seoul National University Hospital; Seoul National University Bundang Hospital; Gachon University Gil Medical Center; Kyungpook National University Hospital; Severance Hospital; Ewha Womans University Mokdong Hospital; Chungnam National University Hospital; DongGuk University
• Investigators: Principal Investigator: Chun Soo Lim, MD, PhD, Seoul National University Boramae Medical Center, Seoul, Republic of Korea.

Publications and helpful links

General Publications

• Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
• Kim YC, Park JY, Oh S, Cho JH, Chang JH, Choi DE, Park JT, Lee JP, Kim S, Kim DK, Ryu DR, Lim CS. Safety and efficacy of PG102P for the control of pruritus in patients undergoing hemodialysis (SNUG trial): study protocol for a randomized controlled trial. Trials. 2019 Nov 28;20(1):651. doi: 10.1186/s13063-019-3753-1.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2018
• Primary Completion (ACTUAL): January 31, 2019
• Study Completion (ACTUAL): March 30, 2019

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (ACTUAL): July 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Hemodialysis; Uremic pruritus
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• Other Study ID Numbers: VM_PG102P

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No