Safety and Efficacy of PG102P for Uremic Pruritus in HD Patients

Uremic Pruritus Clinical Trial

— SNUG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03576235
• Other study ID #: VM_PG102P
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: March 30, 2019

Study information

• Verified date: September 2019
• Source: Seoul National University Boramae Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 30, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pruritus
• Uremic Pruritus

Intervention

Drug:
• PG102P
Daily dose of 1.5g
• Placebo
Daily dose of placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Boramae Medical Center	Seoul

Sponsors (9)

Lead Sponsor	Collaborator
Seoul National University Boramae Hospital	Chungnam National University Hospital, DongGuk University, Ewha Womans University Mokdong Hospital, Gachon University Gil Medical Center, Kyungpook National University Hospital, Seoul National University Bundang Hospital, Seoul National University Hospital, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	serum total IgE	immunoglobulin E	week 0, week 8
Secondary	blood Eosinophil count	Eosinophil count	week 0, week 8
Secondary	serum ECP	Eosinophil Cationic Protein	week 0, week 8
Secondary	serum Ca	serum Calcium	week 0, week 8
Secondary	serum P	serum Phosphorus,	week 0, week 8
Secondary	serum K	serum Potassium	week 0, week 8
Secondary	serum iPTH	intact parathyroid hormone	week 0, week 8
Secondary	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
Secondary	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
Secondary	serum IL-31	inflammatory cytokine	week 0, week 8