Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT00793156
Status:
UNKNOWN
Last Update Posted:
2010-02-04
First Post:
2008-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized-Withdrawal Phase 3 Study Evaluating the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-02-03', 'studyFirstSubmitDate': '2008-11-17', 'studyFirstSubmitQcDate': '2008-11-17', 'lastUpdatePostDateStruct': {'date': '2010-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary efficacy endpoint is the change in worst itching intensity from baseline, compared to that in the last two weeks of the double blind, placebo controlled, randomized withdrawal period.', 'timeFrame': '11 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['uremic pruritus'], '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.'}]}, 'descriptionModule': {'briefSummary': 'Primary objective of this multicenter, double-blind, placebo controlled, randomized withdrawal study are to determine the effectiveness and safety of orally administered AC-820 in doses of 2.5 µg and 5.0 µg daily in patients with moderate to severe itching associated with end-stage renal disease and hemodialysis, and perform a population PK analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 yrs old or older\n* moderate to severe pruritus\n* end stage renal disease\n* 3x weekly hemodialysis\n\nExclusion Criteria:\n\n* pruritus not due to renal disease\n* abnormal liver function\n* Ca-P \\> 80 mg/dl or HgB \\<8.5 g/dl or PTH \\> pg/mL\n* Within four months spKt/V \\< 1.05'}, 'identificationModule': {'nctId': 'NCT00793156', 'acronym': 'AC120-8231', 'briefTitle': 'A Randomized-Withdrawal Phase 3 Study Evaluating the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acologix, Inc.'}, 'officialTitle': 'A Randomized-Withdrawal Phase 3 Study Evaluation the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch)', 'orgStudyIdInfo': {'id': 'AC120-8231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients will be randomized into Placebo group', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '2.5 µg group randomized', 'interventionNames': ['Drug: Nalfurafine HCl 2.5 µg']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': '5.0 µg group randomized', 'interventionNames': ['Drug: Nalfurafine HCl 5.0 µg']}], 'interventions': [{'name': 'Nalfurafine HCl 2.5 µg', 'type': 'DRUG', 'description': 'Daily dose of 2.5 µg', 'armGroupLabels': ['2']}, {'name': 'Nalfurafine HCl 5.0 µg', 'type': 'DRUG', 'description': 'Daily dose of 5.0 µg', 'armGroupLabels': ['3']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo daily dose', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acologix, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dawn McGuire, MD', 'oldOrganization': 'Acologix, Inc'}}}}