Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-25 @ 1:19 PM
Study NCT ID:
NCT06989359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2025-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2025-05-22', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the safety and tolerability of ADX-038', 'timeFrame': 'Length of study - 36 months', 'description': 'Incidence and severity of TEAEs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IgAN', 'C3G', 'Complement-mediated Kidney Disease']}, 'descriptionModule': {'briefSummary': 'This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-038 in adults with complement-mediated kidney diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mean eGFR\n* Clinical evidence of active kidney disease\n* Been on supportive care\n* vaccine requirements\n* Females must not be pregnant or breastfeeding\n* Men must agree to use acceptable contraception and not donate sperm\n* IgAN: confirmed disease by kidney biopsy performed within 60 months prior to screening\n* C3G/IC-MPGN: confirmed disease by kidney biopsy performed within 18 months prior to screening\n\nExclusion Criteria:\n\n* Hereditary or acquired complement deficiency\n* Kidney transplant or renal replacement therapy\n* History of solid organ transplant\n* Other kidney disease\n* History of recurrent invasive infections\n* Received complement inhibitor treatments\n* Active systemic viral, bacterial, or fungal infection\n* Liver dysfunction\n* No donating blood'}, 'identificationModule': {'nctId': 'NCT06989359', 'briefTitle': 'Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'ADARx Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 2 Study to Assess ADX-038 in Participants With Complement-Mediated Kidney Disease', 'orgStudyIdInfo': {'id': 'ADX-038-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active - IgAN', 'description': 'IgAN kidney disease', 'interventionNames': ['Drug: ADX-038']}, {'type': 'EXPERIMENTAL', 'label': 'Active - C3G', 'description': 'C3G kidney disease', 'interventionNames': ['Drug: ADX-038']}], 'interventions': [{'name': 'ADX-038', 'type': 'DRUG', 'description': 'siRNA duplex oligonucleotide', 'armGroupLabels': ['Active - C3G', 'Active - IgAN']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tim Peters-Strickland, MD', 'role': 'CONTACT', 'email': 'tpeters-strickland@adarx.com', 'phone': '877-232-7974'}], 'overallOfficials': [{'name': 'Tim Peters-Strickland, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ADARx Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ADARx Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}