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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03576235
Recruitment Status : Completed
First Posted : July 3, 2018
Last Update Posted : September 19, 2019
Sponsor:
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
Information provided by (Responsible Party):
Chun Soo Lim, Seoul National University Boramae Hospital

Tracking Information
First Submitted Date  ICMJE June 21, 2018
First Posted Date  ICMJE July 3, 2018
Last Update Posted Date September 19, 2019
Actual Study Start Date  ICMJE May 1, 2018
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2018)
VAS change from baseline [ Time Frame: the change in VAS between visit 2 (week 0) and visits 3, 4, 5, and 6 (weeks 2, 4, 8, 10) ]
The primary endpoint is the change in VAS
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03576235 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2018)
  • serum total IgE [ Time Frame: week 0, week 8 ]
    immunoglobulin E
  • blood Eosinophil count [ Time Frame: week 0, week 8 ]
    Eosinophil count
  • serum ECP [ Time Frame: week 0, week 8 ]
    Eosinophil Cationic Protein
  • serum Ca [ Time Frame: week 0, week 8 ]
    serum Calcium
  • serum P [ Time Frame: week 0, week 8 ]
    serum Phosphorus,
  • serum K [ Time Frame: week 0, week 8 ]
    serum Potassium
  • serum iPTH [ Time Frame: week 0, week 8 ]
    intact parathyroid hormone
  • Questionnaire #1 (KDQOL, Kidney Disease and Quality of Life) [ Time Frame: week 0, week 8 ]
    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.
    1. 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)
    2. 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) [ Time Frame: week 0, week 8 ]
    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 [ Time Frame: week 0, week 8 ]
    inflammatory cytokine
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2018)
  • serum total IgE [ Time Frame: week 0, week 8 ]
    immunoglobulin E
  • blood Eosinophil count [ Time Frame: week 0, week 8 ]
    Eosinophil count
  • serum ECP [ Time Frame: week 0, week 8 ]
    Eosinophil Cationic Protein
  • serum Ca [ Time Frame: week 0, week 8 ]
    serum Calcium
  • serum P [ Time Frame: week 0, week 8 ]
    serum Phosphorus,
  • serum K [ Time Frame: week 0, week 8 ]
    serum Potassium
  • serum iPTH [ Time Frame: week 0, week 8 ]
    intact parathyroid hormone
  • Questionnaires (1) [ Time Frame: week 0, week 8 ]
    KDQoL (Kidney Disease and Quality of Life)
  • Questionnaires (2) [ Time Frame: week 0, week 8 ]
    BDI (Beck's Depression Inventory)
  • serum IL-31 [ Time Frame: week 0, week 8 ]
    inflammatory cytokine
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of PG102P for Uremic Pruritus in HD Patients
Official Title  ICMJE Safety and Efficacy of PG102P for the coNtrol of prUritus in Patients underGoing Hemodialysis (SNUG Trial): Study Protocol for a Randomized Control Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Uremic Pruritus
Intervention  ICMJE
  • Drug: PG102P
    Daily dose of 1.5g
  • Drug: Placebo
    Daily dose of placebo
Study Arms  ICMJE
  • Experimental: a treatment group
    PG102P 1.5 g/day
    Intervention: Drug: PG102P
  • Placebo Comparator: a control group
    placebo
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 30, 2019
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03576235
Other Study ID Numbers  ICMJE VM_PG102P
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chun Soo Lim, Seoul National University Boramae Hospital
Study Sponsor  ICMJE Seoul National University Boramae Hospital
Collaborators  ICMJE
  • 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
Investigators  ICMJE
Principal Investigator: Chun Soo Lim, MD, PhD Seoul National University Boramae Medical Center, Seoul, Republic of Korea.
PRS Account Seoul National University Boramae Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP