Safety and Efficacy of PG102P for Uremic Pruritus in HD P... | NCT03576235

Studies
Safety and Efficacy of PG102P for Uremic Pruritus in HD Patients

NCT03576235

Sponsor

Seoul National University Boramae Hospital

Status

Completed

Last Update Posted

Sep 19, 2019Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Uremic Pruritus

Interventions

PG102P
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2018Actual

Primary Completion Date

Jan 31, 2019Actual

Completion Date

Mar 30, 2019Actual

First Submitted Date

Jun 21, 2018

First Submission Date that Met QC Criteria

Jul 2, 2018

First Posted Date

Jul 3, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2019

Last Update Posted Date

Sep 19, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chun Soo Lim, Professor, Seoul National University Boramae HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Boramae HospitalOTHER

Collaborators

Name	Class
Seoul National University Hospital	OTHER
Seoul National University Bundang Hospital	OTHER
Ewha Womans University Mokdong Hospital	OTHER
Severance Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
a treatment group	Experimental	PG102P 1.5 g/day	Drug: PG102P
a control group	Placebo Comparator	placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PG102P	Drug	Daily dose of 1.5g	a treatment group
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
serum total IgE	immunoglobulin E	week 0, week 8
blood Eosinophil count	Eosinophil count	week 0, week 8

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chun Soo Lim, MD, PhD	Seoul National University Boramae Medical Center, Seoul, Republic of Korea.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Boramae Medical Center		Seoul		07061	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33283264	Derived	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.
31779697	Derived	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.