Safety and Efficacy of PG102P for Uremic Pruritus in HD Patients
NCT ID: NCT03576235
Last Updated: 2019-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2018-05-01
2019-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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a treatment group
PG102P 1.5 g/day
PG102P
Daily dose of 1.5g
a control group
placebo
Placebo
Daily dose of placebo
Interventions
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PG102P
Daily dose of 1.5g
Placebo
Daily dose of placebo
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Seoul National University Bundang Hospital
OTHER
Ewha Womans University Mokdong Hospital
OTHER
Severance Hospital
OTHER
Chungnam National University Hospital
OTHER
Gachon University Gil Medical Center
OTHER
Kyungpook National University Hospital
OTHER
DongGuk University
OTHER
Seoul National University Boramae Hospital
OTHER
Responsible Party
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Chun Soo Lim
Professor
Principal Investigators
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Chun Soo Lim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Boramae Medical Center, Seoul, Republic of Korea.
Locations
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Seoul National University Boramae Medical Center
Seoul, , South Korea
Countries
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References
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Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Kim YC, Park JY, Oh S, Cho JH, Chang JH, Choi DE, Park JT, Lee JP, Kim S, Kim DK, Ryu DR, Lim CS. Safety and efficacy of PG102P for the control of pruritus in patients undergoing hemodialysis (SNUG trial): study protocol for a randomized controlled trial. Trials. 2019 Nov 28;20(1):651. doi: 10.1186/s13063-019-3753-1.
Other Identifiers
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VM_PG102P
Identifier Type: -
Identifier Source: org_study_id
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