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Completed

NCT Number: NCT03576235

Safety and Efficacy of PG102P for Uremic Pruritus in HD Patients

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.

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Key information

Conditions

Uremic Pruritus

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PG102P

Drug

Daily dose of 1.5g

Placebo

Drug

Daily dose of placebo

Primary outcomes

  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 outcomes

  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.

    • 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)

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Boramae Hospital

Other

Collaborators

  • Chungnam National University Hospital
  • DongGuk University
  • Ewha Womans University Mokdong Hospital
  • Gachon University Gil Medical Center
  • Kyungpook National University Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital

Registry information

Official study title

Safety and Efficacy of PG102P for the coNtrol of prUritus in Patients underGoing Hemodialysis (SNUG Trial): Study Protocol for a Randomized Control Trial

Acronym: SNUG

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 3, 2018
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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