Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Uremic Pruritus Drug: PG102P Drug: Placebo Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arm Intervention/treatment
Experimental: a treatment group
PG102P 1.5 g/day
Drug: PG102P
Daily dose of 1.5g

Placebo Comparator: a control group
placebo
Drug: Placebo
Daily dose of placebo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. serum total IgE [ Time Frame: week 0, week 8 ]
    immunoglobulin E

  2. blood Eosinophil count [ Time Frame: week 0, week 8 ]
    Eosinophil count

  3. serum ECP [ Time Frame: week 0, week 8 ]
    Eosinophil Cationic Protein

  4. serum Ca [ Time Frame: week 0, week 8 ]
    serum Calcium

  5. serum P [ Time Frame: week 0, week 8 ]
    serum Phosphorus,

  6. serum K [ Time Frame: week 0, week 8 ]
    serum Potassium

  7. serum iPTH [ Time Frame: week 0, week 8 ]
    intact parathyroid hormone

  8. 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)


  9. 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.


  10. serum IL-31 [ Time Frame: week 0, week 8 ]
    inflammatory cytokine



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03576235


Locations
Layout table for location information
Korea, Republic of
Seoul National University Boramae Medical Center
Seoul, Korea, Republic of, 07061
Sponsors and Collaborators
Seoul National University Boramae Hospital
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
Layout table for investigator information
Principal Investigator: Chun Soo Lim, MD, PhD Seoul National University Boramae Medical Center, Seoul, Republic of Korea.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Chun Soo Lim, Professor, Seoul National University Boramae Hospital
ClinicalTrials.gov Identifier: NCT03576235     History of Changes
Other Study ID Numbers: VM_PG102P
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chun Soo Lim, Seoul National University Boramae Hospital:
Uremic pruritus
Hemodialysis
Additional relevant MeSH terms:
Layout table for MeSH terms
Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms