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

S

Seoul National University Boramae Hospital

Status

Completed

Conditions

Uremic Pruritus

Treatments

Drug: PG102P
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03576235
VM_PG102P

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

19+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups, including a placebo group

a treatment group
Experimental group
Description:
PG102P 1.5 g/day
Treatment:
Drug: PG102P
a control group
Placebo Comparator group
Description:
placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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