search
Back to results

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

Primary Purpose

Uremic Pruritus

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PG102P
Placebo
Sponsored by
Seoul National University Boramae Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uremic Pruritus focused on measuring Uremic pruritus, Hemodialysis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

a treatment group

a control group

Arm Description

PG102P 1.5 g/day

placebo

Outcomes

Primary Outcome Measures

VAS change from baseline
The primary endpoint is the change in VAS

Secondary Outcome Measures

serum total IgE
immunoglobulin E
blood Eosinophil count
Eosinophil count
serum ECP
Eosinophil Cationic Protein
serum Ca
serum Calcium
serum P
serum Phosphorus,
serum K
serum Potassium
serum iPTH
intact parathyroid hormone
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)
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.
serum IL-31
inflammatory cytokine

Full Information

First Posted
June 21, 2018
Last Updated
September 17, 2019
Sponsor
Seoul National University Boramae Hospital
Collaborators
Seoul National University Hospital, Seoul National University Bundang Hospital, Ewha Womans University Mokdong Hospital, Severance Hospital, Chungnam National University Hospital, Gachon University Gil Medical Center, Kyungpook National University Hospital, DongGuk University
search

1. Study Identification

Unique Protocol Identification Number
NCT03576235
Brief Title
Safety and Efficacy of PG102P for Uremic Pruritus in HD Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Boramae Hospital
Collaborators
Seoul National University Hospital, Seoul National University Bundang Hospital, Ewha Womans University Mokdong Hospital, Severance Hospital, Chungnam National University Hospital, Gachon University Gil Medical Center, Kyungpook National University Hospital, DongGuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremic Pruritus
Keywords
Uremic pruritus, Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
a treatment group
Arm Type
Experimental
Arm Description
PG102P 1.5 g/day
Arm Title
a control group
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
PG102P
Intervention Description
Daily dose of 1.5g
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Daily dose of placebo
Primary Outcome Measure Information:
Title
VAS change from baseline
Description
The primary endpoint is the change in VAS
Time Frame
the change in VAS between visit 2 (week 0) and visits 3, 4, 5, and 6 (weeks 2, 4, 8, 10)
Secondary Outcome Measure Information:
Title
serum total IgE
Description
immunoglobulin E
Time Frame
week 0, week 8
Title
blood Eosinophil count
Description
Eosinophil count
Time Frame
week 0, week 8
Title
serum ECP
Description
Eosinophil Cationic Protein
Time Frame
week 0, week 8
Title
serum Ca
Description
serum Calcium
Time Frame
week 0, week 8
Title
serum P
Description
serum Phosphorus,
Time Frame
week 0, week 8
Title
serum K
Description
serum Potassium
Time Frame
week 0, week 8
Title
serum iPTH
Description
intact parathyroid hormone
Time Frame
week 0, week 8
Title
Questionnaire #1 (KDQOL, Kidney Disease and Quality of Life)
Description
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)
Time Frame
week 0, week 8
Title
Questionnaire #2 (BDI, Beck's Depression Inventory)
Description
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.
Time Frame
week 0, week 8
Title
serum IL-31
Description
inflammatory cytokine
Time Frame
week 0, week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun Soo Lim, MD, PhD
Organizational Affiliation
Seoul National University Boramae Medical Center, Seoul, Republic of Korea.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33283264
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.
Results Reference
derived
PubMed Identifier
31779697
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.
Results Reference
derived

Learn more about this trial

Safety and Efficacy of PG102P for Uremic Pruritus in HD Patients

We'll reach out to this number within 24 hrs