Clinical trial NCT03576235: Safety and Efficacy of PG102P for Uremic Pruritus in HD Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uremic Pruritus
Keywords: Uremic pruritus
Hemodialysis
Lead sponsor: Seoul National University Boramae Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
name: Seoul National University Bundang Hospital
name: Ewha Womans University Mokdong Hospital
name: Severance Hospital
name: Chungnam National University Hospital
name: Gachon University Gil Medical Center
name: Kyungpook National University Hospital
name: DongGuk University
First posted: 2018-07-03
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS change from baseline
timeFrame: the change in VAS between visit 2 (week 0) and visits 3, 4, 5, and 6 (weeks 2, 4, 8, 10)
Secondary outcomes:
measure: serum total IgE
timeFrame: week 0, week 8
measure: blood Eosinophil count
timeFrame: week 0, week 8
measure: serum ECP
timeFrame: week 0, week 8
measure: serum Ca
timeFrame: week 0, week 8
measure: serum P
timeFrame: week 0, week 8
measure: serum K
timeFrame: week 0, week 8
measure: serum iPTH
timeFrame: week 0, week 8
measure: Questionnaire #1 (KDQOL, Kidney Disease and Quality of Life)
timeFrame: week 0, week 8
measure: Questionnaire #2 (BDI, Beck's Depression Inventory)
timeFrame: week 0, week 8
measure: serum IL-31
timeFrame: week 0, week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
Study officials:
affiliation: Seoul National University Boramae Medical Center, Seoul, Republic of Korea.
name: Chun Soo Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
citation: Kim YC, Park JY, Oh S, Cho JH, Chang JH, Choi DE, Park JT, Lee JP, Kim S, Kim DK, Ryu DR, Lim CS. Safety and efficacy of PG102P for the control of pruritus in patients undergoing hemodialysis (SNUG trial): study protocol for a randomized controlled trial. Trials. 2019 Nov 28;20(1):651. doi: 10.1186/s13063-019-3753-1.