Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-01-05 @ 5:36 PM
Study NCT ID:
NCT06466135
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2024-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of WAL0921 in Patients With Glomerular Kidney Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'D009402', 'term': 'Nephrosis, Lipoid'}, {'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009401', 'term': 'Nephrosis'}, {'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2024-06-12', 'studyFirstSubmitQcDate': '2024-06-18', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment emergent adverse events', 'timeFrame': 'Baseline to Week 36'}], 'secondaryOutcomes': [{'measure': 'Change in albuminuria', 'timeFrame': 'Baseline up to Week 24', 'description': 'Percent change in urine albumin-creatinine ratio (UACR)'}, {'measure': 'Change in proteinuria', 'timeFrame': 'Baseline up to Week 24', 'description': 'Percent change in urine protein-creatinine ratio (UPCR)'}, {'measure': 'Change in estimated glomerular filtration rate', 'timeFrame': 'Baseline up to Week 24', 'description': 'Percent change in estimated glomerular filtration rate (eGFR)'}, {'measure': 'Change in rate of change in eGFR', 'timeFrame': 'Baseline up to Week 24', 'description': 'Slope of eGFR'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DN', 'FSGS', 'TR-MCD', 'IgAN', 'PMN'], 'conditions': ['Diabetic Nephropathies', 'Primary Focal Segmental Glomerulosclerosis', 'Minimal Change Disease', 'Primary Immunoglobulin A Nephropathy', 'Primary Membranous Nephropathy']}, 'descriptionModule': {'briefSummary': 'This is an adaptive prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921 in subjects with glomerular kidney disease and proteinuria, including diabetic nephropathy and rare glomerular kidney diseases (primary focal segmental glomerulosclerosis \\[FSGS\\], treatment-resistant minimal change disease \\[TR MCD\\], primary immunoglobulin A nephropathy \\[IgAN\\], and primary membranous nephropathy \\[PMN\\]). Subjects in this study will be randomized to receive the investigational drug WAL0921 or placebo as an intravenous infusion once every 2 weeks for 7 total infusions. All subjects will be followed for 24 weeks after their last infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults, age 18-75 years\n* Diagnosis of one of the following glomerular kidney diseases: diabetic nephropathy; primary focal segmental glomerulosclerosis; treatment resistant-minimal change disease; primary IgA nephropathy; primary membranous nephropathy\n* eGFR greater than or equal to 30 mL/min/1.73 m2\n\nExclusion Criteria:\n\n* Currently pregnant or planning to become pregnant\n* History of organ transplantation\n* History of alcohol or substance use disorder\n* Acute dialysis or acute kidney injury within 6 months of Screening\n* Any prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements'}, 'identificationModule': {'nctId': 'NCT06466135', 'briefTitle': 'Study of WAL0921 in Patients With Glomerular Kidney Diseases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Walden Biosciences'}, 'officialTitle': 'Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria', 'orgStudyIdInfo': {'id': 'WAL0921-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WAL0921', 'description': 'Intravenous infusion of investigational drug WAL0921', 'interventionNames': ['Drug: WAL0921']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intravenous infusion of normal saline', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'WAL0921', 'type': 'DRUG', 'description': 'Investigational drug WAL0921 Participants receive an intravenous infusion of WAL0921 investigational drug once every 2 weeks for 7 total infusions.', 'armGroupLabels': ['WAL0921']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo product Participants receive an intravenous infusion of placebo once every 2 weeks for 7 total infusions.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80012', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Colorado Kidney and Vascular Care', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33321', 'city': 'Tamarac', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'D & H Tamarac Research Center', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '3021', 'city': 'St Albans', 'state': 'Victoria', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': 'Western Health Sunshine Hospital', 'geoPoint': {'lat': -37.74496, 'lon': 144.80049}}, {'zip': 'DE22 3NE', 'city': 'Derby', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Michelle Skupian', 'role': 'CONTACT', 'email': 'clinicaltrials@waldenbiosciences.com', 'phone': '+1 857 314 1961'}], 'facility': 'Royal Derby Hospital', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'zip': 'LE1 7RH', 'city': 'Leicester', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Michelle Skupian', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'clinicaltrials@waldenbiosciences.com', 'phone': '+1 8573141961'}], 'facility': 'College of Life Sciences, University of Leicester', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'E1 2ES', 'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Michelle Skupian', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'clinicaltrials@waldenbiosciences.com', 'phone': '+1 8573141961'}], 'facility': 'Barts Health NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Michelle Skupian', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'clinicaltrials@waldenbiosciences.com', 'phone': '+1 8573141961'}], 'facility': 'Manchester University NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'M6 8HD', 'city': 'Salford', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'michelle Skupian', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'clinicaltrials@waldenbiosciences.com', 'phone': '+1 8573141961'}], 'facility': 'Salford Royal NHS Foundation Trust', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}], 'centralContacts': [{'name': 'Michelle Skupien', 'role': 'CONTACT', 'email': 'clinicaltrials@waldenbiosciences.com', 'phone': '8573141961'}], 'overallOfficials': [{'name': 'Andrew Blair, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Walden Biosciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Walden Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}