Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT03576235
Status:
COMPLETED
Last Update Posted:
2019-09-19
First Post:
2018-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of PG102P for Uremic Pruritus in HD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2018-06-21', 'studyFirstSubmitQcDate': '2018-07-02', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS change from baseline', 'timeFrame': 'the change in VAS between visit 2 (week 0) and visits 3, 4, 5, and 6 (weeks 2, 4, 8, 10)', 'description': 'The primary endpoint is the change in VAS'}], 'secondaryOutcomes': [{'measure': 'serum total IgE', 'timeFrame': 'week 0, week 8', 'description': 'immunoglobulin E'}, {'measure': 'blood Eosinophil count', 'timeFrame': 'week 0, week 8', 'description': 'Eosinophil count'}, {'measure': 'serum ECP', 'timeFrame': 'week 0, week 8', 'description': 'Eosinophil Cationic Protein'}, {'measure': 'serum Ca', 'timeFrame': 'week 0, week 8', 'description': 'serum Calcium'}, {'measure': 'serum P', 'timeFrame': 'week 0, week 8', 'description': 'serum Phosphorus,'}, {'measure': 'serum K', 'timeFrame': 'week 0, week 8', 'description': 'serum Potassium'}, {'measure': 'serum iPTH', 'timeFrame': 'week 0, week 8', 'description': 'intact parathyroid hormone'}, {'measure': 'Questionnaire #1 (KDQOL, Kidney Disease and Quality of Life)', 'timeFrame': 'week 0, week 8', 'description': '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.\n\n1. Kidney disease targeted (number of items)\n\n 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)\n2. SF-36 (number of items)\n\nPhysical functioning (10), Role-physical (4), Bodily pain (2), General health (5), Mental health (5), Role-emotional (3), Social functioning (2), Vitality (4)'}, {'measure': "Questionnaire #2 (BDI, Beck's Depression Inventory)", 'timeFrame': 'week 0, week 8', 'description': '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.\n\n0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, 29-63: severe depression.'}, {'measure': 'serum IL-31', 'timeFrame': 'week 0, week 8', 'description': 'inflammatory cytokine'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uremic pruritus', 'Hemodialysis'], 'conditions': ['Uremic Pruritus']}, 'referencesModule': {'references': [{'pmid': '33283264', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '31779697', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age over 19 years\n2. Patients with adequate HD (Kt/V \\> 1.2)\n3. Maintenance patients undergoing HD with chronic pruritus\n4. Mean visual analog scale (VAS) over 4 of the last 5 days in the 14-day pre-observation period\n5. 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\n6. Patients who agreed to participate in this trial and had written an informed consent\n\nExclusion Criteria:\n\n1. Intact parathyroid hormone (iPTH) \\> 1000 pg/mL within 1 month\n2. Serum potassium \\> 7.0 mg/dL\n3. HIV Ab (+)\n4. Aspartate transaminase (AST) (glutamic oxaloacetic transaminase) or alanine transaminase (ALT) (glutamic pyruvic transaminase) \\> 3 times the upper limit of normal\n5. Scheduled to have kidney transplantation within 3 months\n6. Cancer history with current treatment\n7. Active infection with current treatment\n8. Current itching with dermatologic diseases other than uremic pruritus\n9. Pregnancy, childbearing potential during the study period, or breastfeeding\n10. Allergy or hypersensitivity reaction to PG102P\n11. History of participating another clinical trial within 2 months or planning to participate another clinical trial\n12. Not eligible to participate this trial as researchers' decision"}, 'identificationModule': {'nctId': 'NCT03576235', 'acronym': 'SNUG', 'briefTitle': 'Safety and Efficacy of PG102P for Uremic Pruritus in HD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Boramae Hospital'}, 'officialTitle': 'Safety and Efficacy of PG102P for the coNtrol of prUritus in Patients underGoing Hemodialysis (SNUG Trial): Study Protocol for a Randomized Control Trial', 'orgStudyIdInfo': {'id': 'VM_PG102P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'a treatment group', 'description': 'PG102P 1.5 g/day', 'interventionNames': ['Drug: PG102P']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'a control group', 'description': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PG102P', 'type': 'DRUG', 'description': 'Daily dose of 1.5g', 'armGroupLabels': ['a treatment group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Daily dose of placebo', 'armGroupLabels': ['a control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07061', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Chun Soo Lim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Boramae Medical Center, Seoul, Republic of Korea.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Boramae Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Hospital', 'class': 'OTHER'}, {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, {'name': 'Ewha Womans University Mokdong Hospital', 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}, {'name': 'Chungnam National University Hospital', 'class': 'OTHER'}, {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, {'name': 'DongGuk University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chun Soo Lim', 'investigatorAffiliation': 'Seoul National University Boramae Hospital'}}}}