NCT03576235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 3, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

June 21, 2018

Last Update Submit

September 17, 2019

Conditions

Uremic Pruritus

Keywords

Uremic pruritusHemodialysis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • serum total IgE

    week 0, week 8

  • blood Eosinophil count

    week 0, week 8

  • serum ECP

    week 0, week 8

  • serum Ca

    week 0, week 8

  • serum P

    week 0, week 8

  • +5 more secondary outcomes

Study Arms (2)

a treatment group

EXPERIMENTAL

PG102P 1.5 g/day

Drug: PG102P

a control group

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

PG102PDRUG

Daily dose of 1.5g

a treatment group
PlaceboDRUG

Daily dose of placebo

a control group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 33283264DERIVED

  • 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.

    PMID: 31779697DERIVED

Study Officials

  • Chun Soo Lim, MD, PhD

    Seoul National University Boramae Medical Center, Seoul, Republic of Korea.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 21, 2018

First Posted

July 3, 2018

Study Start

May 1, 2018

Primary Completion

January 31, 2019

Study Completion

March 30, 2019

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

KR(1)