Uremic Pruritus
Conditions
Keywords
Uremic pruritus, Hemodialysis
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.
Interventions
DRUGPG102P
Daily dose of 1.5g
DRUGPlacebo
Daily dose of placebo
Sponsors
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
Seoul National University Boramae Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS change from baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| blood Eosinophil count | week 0, week 8 | Eosinophil count |
| serum ECP | week 0, week 8 | Eosinophil Cationic Protein |
| serum Ca | week 0, week 8 | serum Calcium |
| serum P | week 0, week 8 | serum Phosphorus, |
| serum total IgE | week 0, week 8 | immunoglobulin E |
| serum iPTH | week 0, week 8 | intact parathyroid hormone |
| Questionnaire #1 (KDQOL, Kidney Disease and Quality of Life) | 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) | 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 | week 0, week 8 | inflammatory cytokine |
| serum K | week 0, week 8 | serum Potassium |
Countries
South Korea
Outcome results
None listed