Safety and Efficacy of PG102P for Uremic Pruritus in HD Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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 Control Trial

Conditions
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Uremic Pruritus

Intervention / Treatment
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* Drug: PG102P
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 19 years Patients with adequate HD (Kt/V > 1.2) Maintenance patients undergoing HD with chronic pruritus Mean visual analog scale (VAS) over 4 of the last 5 days in the 14-day pre-observation period 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 Patients who agreed to participate in this trial and had written an informed consent Exclusion Criteria: Intact parathyroid hormone (iPTH) > 1000 pg/mL within 1 month Serum potassium > 7.0 mg/dL HIV Ab (+) Aspartate transaminase (AST) (glutamic oxaloacetic transaminase) or alanine transaminase (ALT) (glutamic pyruvic transaminase) > 3 times the upper limit of normal Scheduled to have kidney transplantation within 3 months Cancer history with current treatment Active infection with current treatment Current itching with dermatologic diseases other than uremic pruritus Pregnancy, childbearing potential during the study period, or breastfeeding Allergy or hypersensitivity reaction to PG102P History of participating another clinical trial within 2 months or planning to participate another clinical trial Not eligible to participate this trial as researchers' decision

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: a treatment group<br>PG102P 1.5 g/day | Drug: PG102P<br>* Daily dose of 1.5g<br>|
| Placebo Comparator: a control group<br>placebo | Drug: Placebo<br>* Daily dose of placebo<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uremic pruritus, Hemodialysis