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

Seoul National University Boramae Hospital

Status: Completed

Conditions: Uremic Pruritus

Treatments: Drug: PG102P; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03576235

VM_PG102P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups, including a placebo group

a treatment group

Experimental group

Description:

PG102P 1.5 g/day

Treatment:

Drug: PG102P

a control group

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo