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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Seoul National University Boramae Medical Center
Seoul, South Korea
VAS change from baseline
The primary endpoint is the change in VAS
Time frame: the change in VAS between visit 2 (week 0) and visits 3, 4, 5, and 6 (weeks 2, 4, 8, 10)
serum total IgE
immunoglobulin E
Time frame: week 0, week 8
blood Eosinophil count
Eosinophil count
Time frame: week 0, week 8
serum ECP
Eosinophil Cationic Protein
Time frame: week 0, week 8
serum Ca
serum Calcium
Time frame: week 0, week 8
serum P
serum Phosphorus,
Time frame: week 0, week 8
serum K
serum Potassium
Time frame: week 0, week 8
serum iPTH
intact parathyroid hormone
Time frame: 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. 1. 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) 2. 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)
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Time frame: 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.
Time frame: week 0, week 8
serum IL-31
inflammatory cytokine
Time frame: week 0, week 8