Safety and Efficacy of PG102P for Uremic Pruritus in HD Patients

• Status: Completed
• Trial end date: 2019-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Boramae Hospital
• Collaborators: Chungnam National University Hospital; DongGuk University; Ewha Womans University Mokdong Hospital; Gachon University Gil Medical Center; Kyungpook National University; Kyungpook National University Hospital; Seoul National University Bundang Hospital; Seoul National University Hospital; Severance Hospital

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