Safety and Efficacy of PG102P for Uremic Pruritus in HD Patients

Not Applicable

Completed

• Conditions: Uremic Pruritus
• Interventions: Drug: Placebo; Drug: PG102P

• Registration Number: NCT03576235
• Lead Sponsor: Seoul National University Boramae Hospital

Brief Summary

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

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 Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-06-21
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-03
• Primary Completion: 2019-01-31
• Study Completion: 2019-03-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
a control group	Placebo	placebo
a treatment group	PG102P	PG102P 1.5 g/day

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
serum total IgE	week 0, week 8	immunoglobulin E
serum ECP	week 0, week 8	Eosinophil Cationic Protein
serum P	week 0, week 8	serum Phosphorus,
serum iPTH	week 0, week 8	intact parathyroid hormone
Questionnaire #2 (BDI, Beck's Depression Inventory)	week 0, week 8	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.
serum Ca	week 0, week 8	serum Calcium
serum K	week 0, week 8	serum Potassium
blood Eosinophil count	week 0, week 8	Eosinophil count
Questionnaire #1 (KDQOL, Kidney Disease and Quality of Life)	week 0, week 8	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)
serum IL-31	week 0, week 8	inflammatory cytokine

Trial Locations

Locations (1)

Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of