Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-28 @ 8:17 AM
Study NCT ID:
NCT00782561
Status:
TERMINATED
Last Update Posted:
2019-07-31
First Post:
2008-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005923', 'term': 'Glomerulosclerosis, Focal Segmental'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C560078', 'term': 'pamrevlumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2009-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2008-10-27', 'studyFirstSubmitQcDate': '2008-10-28', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of FG-3019 as measured by AEs, SAEs, physical exams, lab tests, and the Treatment Satisfaction Questionnaire for Medications', 'timeFrame': '32 weeks'}], 'secondaryOutcomes': [{'measure': 'Standard plasma and urinary PK parameters', 'timeFrame': '32 weeks'}, {'measure': 'Change from baseline in urinary protein/creatinine, albumin/creatinine, albumin excretion rate, estimated glomerular filtration rate (eGFR), 24 hour urinary protein and fasting serum lipids', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['steroid resistant focal segmental glomerulosclerosis', 'FSGS', 'adolescent focal segmental glomerulosclerosis', 'focal segmental glomerulosclerosis'], 'conditions': ['Focal Segmental Glomerulosclerosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of FG-3019 administered over 8 weeks to adolescent and adult subjects with steroid-resistant focal segmental glomerulosclerosis (FSGS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '64 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 12-64 years, inclusive, and girls age 10-11 years, inclusive if Tanner stage 3 or greater\n2. Biopsy diagnosis of primary FSGS with biopsy confirmed centrally\n3. Age less than or equal to 2 years old at onset of proteinuria\n4. First morning urine protein/creatinine ratio (U p/c) \\>1 gm/gm\n5. Estimated glomerular filtration rate greater than or equal to 40 mL/min/1.73 m2\n\nExclusion Criteria:\n\n1. Non-FSGS renal disease other than benign cyst; or secondary FSGS\n2. History of organ transplantation\n3. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies\n4. History of malignancy, cardiovascular disease, diabetes mellitus, sickle cell disease, multiple sclerosis, systemic lupus erythematosus, or active or recurrent serious infections (including but not limited to Hepatitis B, Hepatitis C, or HIV)\n5. Participation in studies of investigational drugs within 6 weeks prior to Day 0 or receipt of an investigational drug within 12 weeks prior to Day 0\n6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2.5 times the upper limit of normal\n7. Hematocrit \\< 30%'}, 'identificationModule': {'nctId': 'NCT00782561', 'briefTitle': 'Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'FibroGen'}, 'officialTitle': 'A Phase I, Open-Label Study of the Safety and Pharmacokinetics of FG-3019 in Adolescent and Adult Subjects With Steroid-Resistant Focal Segmental Glomerulosclerosis', 'orgStudyIdInfo': {'id': 'FGCL-MC3019-026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FG-3019', 'description': 'FG-3019 5 mg/kg', 'interventionNames': ['Drug: FG-3019']}], 'interventions': [{'name': 'FG-3019', 'type': 'DRUG', 'description': 'FG-3019 5 mg/kg IV given over 2 hours every 2 weeks for 8 weeks', 'armGroupLabels': ['FG-3019']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '27599-7155', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FibroGen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}