Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-25 @ 3:08 PM
Study NCT ID:
NCT04009668
Status:
COMPLETED
Last Update Posted:
2024-10-30
First Post:
2019-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537834', 'term': 'Macular dystrophy, corneal type 1'}, {'id': 'D005923', 'term': 'Glomerulosclerosis, Focal Segmental'}, {'id': 'D009402', 'term': 'Nephrosis, Lipoid'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D009404', 'term': 'Nephrotic Syndrome'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'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': 'D009401', 'term': 'Nephrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'modiz@med.umich.edu', 'phone': '(734) 232-6798', 'title': 'Dr. Zubin Modi', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Recruitment was launched in Dec. 2019 and was significantly impacted by the COVID-19 pandemic with most participants enrolling in 2022.\n\nOne participant was unable to attend the week 10 visit because of COVID-19 infection, and the week 8 biomarker results were used to determine the primary outcome.'}}, 'adverseEventsModule': {'timeFrame': '14 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Adalimumab', 'description': 'Adalimumab dose every other week (study weeks 0, 2, 4, 6, and 8), subcutaneously. Adalimumab will be dosed based on weight (20 mg for subjects weighing 15kg to \\<30kg, or 40 mg for subjects \\>30kg).', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Volume depletion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'eGFR decline (greater than 25% since baseline)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 5, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anasarca and AKI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Urine MCP1/Cr Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Adalimumab dose every other week (study weeks 0, 2, 4, 6, and 8), subcutaneously. Adalimumab will be dosed based on weight (20 mg for subjects weighing 15kg to \\<30kg, or 40 mg for subjects \\>30kg).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.57', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '6.61'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '2.89', 'groupId': 'OG000', 'lowerLimit': '1.36', 'upperLimit': '7.14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '10 Weeks', 'description': 'MCP1 is an established marker of intra-renal TNF pathway activation. A reduction in MCP1 reflects a reduction in the activation of the TNF pathway in the kidney. Values were measured by enzyme-linked immunosorbent assay (ELISA) testing and standardized over serum creatinine.', 'unitOfMeasure': 'ng/mg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Urine TIMP1/Cr Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Adalimumab dose every other week (study weeks 0, 2, 4, 6, and 8), subcutaneously. Adalimumab will be dosed based on weight (20 mg for subjects weighing 15kg to \\<30kg, or 40 mg for subjects \\>30kg).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '41.34', 'groupId': 'OG000', 'lowerLimit': '3.64', 'upperLimit': '75.38'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '31.36', 'groupId': 'OG000', 'lowerLimit': '4.39', 'upperLimit': '146.86'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '10 Weeks', 'description': 'TIMP1 is an established marker of intra-renal TNF pathway activation. A reduction in TIMP1 reflects a reduction in the activation of the TNF pathway in the kidney. Values were measured by enzyme-linked immunosorbent assay (ELISA) testing and standardized over serum creatinine.', 'unitOfMeasure': 'ng/mg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Adalimumab dose every other week (study weeks 0, 2, 4, 6, and 8), subcutaneously. Adalimumab will be dosed based on weight (20 mg for subjects weighing 15kg to \\<30kg, or 40 mg for subjects \\>30kg).'}], 'classes': [{'title': 'Mild AEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Moderate AEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Severe AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Serious AEs', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 weeks', 'description': 'AEs for this outcome measure were classified using the following definitions:\n\n* Mild: no or mild symptoms, and not requiring intervention\n* Moderate: with minimal or local intervention, and limiting age-appropriate activities\n* Severe: intervention necessary and limiting age-appropriate activities but not immediately life-threatening, and requiring hospitalization or prolongation of hospitalization\n* Serious AE: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, pregnancy or congenital anomaly/birth defect.\n\nSome participants experienced multiple types of AE during the course of the trial.', 'unitOfMeasure': 'Adverse Event', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Estimated Glomerular Filtration Rate (eGFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Adalimumab dose every other week (study weeks 0, 2, 4, 6, and 8), subcutaneously. Adalimumab will be dosed based on weight (20 mg for subjects weighing 15kg to \\<30kg, or 40 mg for subjects \\>30kg).'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.90', 'groupId': 'OG000', 'lowerLimit': '-30.50', 'upperLimit': '-12.18'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '10 Weeks', 'description': 'eGFR is a measure of kidney functioning based on a blood sample and clinical information to calculate it. Normal kidney function is greater than 90 ml/min/1.73 m2. Result data is the percent change in eGFR following the intervention. The lower the number shows the greater decline in kidney function.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Urine Protein Creatinine Ratio (UPCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Adalimumab dose every other week (study weeks 0, 2, 4, 6, and 8), subcutaneously. Adalimumab will be dosed based on weight (20 mg for subjects weighing 15kg to \\<30kg, or 40 mg for subjects \\>30kg).'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.60', 'groupId': 'OG000', 'lowerLimit': '-23.45', 'upperLimit': '-9.28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '10 Weeks', 'description': 'UPCR is a measure of protein spillage from the kidney based on a urine specimen. Normal reference range is less than 0.03 mg/mg. Result is the percent change in UPCR following the intervention, with lower number showing less protein spilling from the kidney, reflecting better disease control.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Who Achieved Both a Nadir Urine Protein Creatinine Ratio (UPCR) of Less Than 1.5 g/g and at Least a 40% Reduction From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'Adalimumab dose every other week (study weeks 0, 2, 4, 6, and 8), subcutaneously. Adalimumab will be dosed based on weight (20 mg for subjects weighing 15kg to \\<30kg, or 40 mg for subjects \\>30kg).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 Weeks', 'description': 'UPCR is a measure of protein spillage from the kidney based on a urine specimen. Normal reference range is less than 0.03 mg/mg. Result is the count of participants who simultaneously met the criteria of having both a raw UPCR value of less than 1.5 g/g and at least a 40% reduction from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adalimumab', 'description': 'Adalimumab dose every other week (study weeks 0, 2, 4, 6, and 8), subcutaneously. Adalimumab will be dosed based on weight (20 mg for subjects weighing 15kg to \\<30kg, or 40 mg for subjects \\>30kg).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Recruitment Period: 2019-2023 Recruitment Sites: University of Michigan, Ann Arbor, MI; New York University Langone Health, New York, NY; Cleveland Clinic, Cleveland, OH; Levine Children's Hospital at Atrium Health, Charlotte, NC.", 'preAssignmentDetails': 'Following consent, participants provided a urine sample to measure urinary monocyte chemoattractant protein-1 (uMCP-1) and urinary tissue inhibitor of metalloprotease-1 (uTIMP-1), two indicators of intra-renal tumor necrosis factor (TNF) pathway activation. Participants with present TNF activation were advanced to screening. Upon confirmation of eligibility, participants proceeded to the treatment phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Adalimumab', 'description': 'Adalimumab dose every other week (study weeks 0, 2, 4, 6, and 8), subcutaneously. Adalimumab will be dosed based on weight (20 mg for subjects weighing 15kg to \\<30kg, or 40 mg for subjects \\>30kg).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'groupId': 'BG000', 'lowerLimit': '12.8', 'upperLimit': '19.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-21', 'size': 1135022, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-09-27T14:50', 'hasProtocol': True}, {'date': '2023-10-31', 'size': 649546, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-27T14:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-03', 'studyFirstSubmitDate': '2019-07-02', 'resultsFirstSubmitDate': '2024-10-03', 'studyFirstSubmitQcDate': '2019-07-02', 'lastUpdatePostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-03', 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Urine MCP1/Cr Levels', 'timeFrame': '10 Weeks', 'description': 'MCP1 is an established marker of intra-renal TNF pathway activation. A reduction in MCP1 reflects a reduction in the activation of the TNF pathway in the kidney. Values were measured by enzyme-linked immunosorbent assay (ELISA) testing and standardized over serum creatinine.'}, {'measure': 'Change in Urine TIMP1/Cr Levels', 'timeFrame': '10 Weeks', 'description': 'TIMP1 is an established marker of intra-renal TNF pathway activation. A reduction in TIMP1 reflects a reduction in the activation of the TNF pathway in the kidney. Values were measured by enzyme-linked immunosorbent assay (ELISA) testing and standardized over serum creatinine.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': '14 weeks', 'description': 'AEs for this outcome measure were classified using the following definitions:\n\n* Mild: no or mild symptoms, and not requiring intervention\n* Moderate: with minimal or local intervention, and limiting age-appropriate activities\n* Severe: intervention necessary and limiting age-appropriate activities but not immediately life-threatening, and requiring hospitalization or prolongation of hospitalization\n* Serious AE: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, pregnancy or congenital anomaly/birth defect.\n\nSome participants experienced multiple types of AE during the course of the trial.'}, {'measure': 'Change in Estimated Glomerular Filtration Rate (eGFR)', 'timeFrame': '10 Weeks', 'description': 'eGFR is a measure of kidney functioning based on a blood sample and clinical information to calculate it. Normal kidney function is greater than 90 ml/min/1.73 m2. Result data is the percent change in eGFR following the intervention. The lower the number shows the greater decline in kidney function.'}, {'measure': 'Change in Urine Protein Creatinine Ratio (UPCR)', 'timeFrame': '10 Weeks', 'description': 'UPCR is a measure of protein spillage from the kidney based on a urine specimen. Normal reference range is less than 0.03 mg/mg. Result is the percent change in UPCR following the intervention, with lower number showing less protein spilling from the kidney, reflecting better disease control.'}, {'measure': 'Proportion of Participants Who Achieved Both a Nadir Urine Protein Creatinine Ratio (UPCR) of Less Than 1.5 g/g and at Least a 40% Reduction From Baseline', 'timeFrame': '10 Weeks', 'description': 'UPCR is a measure of protein spillage from the kidney based on a urine specimen. Normal reference range is less than 0.03 mg/mg. Result is the count of participants who simultaneously met the criteria of having both a raw UPCR value of less than 1.5 g/g and at least a 40% reduction from baseline.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney Disease', 'Minimal Change Disease', 'Nephrotic Syndrome', 'Focal Segmental Glomerulosclerosis', 'FSGS'], 'conditions': ['FSGS', 'MCD', 'Focal Segmental Glomerulosclerosis', 'Minimal Change Disease']}, 'referencesModule': {'references': [{'pmid': '39808779', 'type': 'DERIVED', 'citation': 'Trachtman H, Modi ZJ, Ju W, Lee E, Chinnakotla S, Massengill S, Sedor J, Mariani L, Zhai Y, Hao W, Desmond H, Eddy S, Ramani K, Spino C, Kretzler M. Precision Medicine Proof-of-Concept Study of a TNF Inhibitor in FSGS and Treatment-Resistant Minimal Change Disease. Kidney360. 2025 Feb 1;6(2):284-295. doi: 10.34067/KID.0000000635. Epub 2024 Nov 18.'}]}, 'descriptionModule': {'briefSummary': 'Adalimumab, a treatment which blocks tumor necrosis factor (TNF), was tested to see if it changed levels of urine biomarker levels, tissue inhibitor of metalloprotease-1 (TIMP1), and monocyte chemoattractant protein-1 (MCP1). Results may help develop individualized treatment options for future patients with TNF-driven focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kidney biopsy confirmed Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)\n* For Minimal Change Disease patients only, history of resistance to corticosteroid therapy\n* Increased urinary excretion of biomarkers of Tumor Necrosis Factor (TNF) activation (MCP1/Cr and/ or TIMP1/Cr) at study screening\n* eGFR\\>30 ml/min/1.73 m2 at screening\n* Urine protein:creatinine ratio ≥1.5 g/g at screening\n* Weight \\>15 kg\n* Stable therapy with angiotensin converting enzyme inhibitors, angiotensin receptor blockers, and oral immunosuppression agents for at least 30 days prior to enrollment\n* Birth control use in females of child bearing potential\n* Informed consent and assent if applicable\n\nExclusion Criteria:\n\n* Kidney or other solid organ or bone marrow transplant recipient\n* Allergy or intolerance to investigational agent\n* Secondary Focal Segmental Glomerulosclerosis (FSGS)\n* Severe obesity\n* Live virus vaccine in the past 3 months\n* Malignancy, current or in the past 5 years\n* Active local or systemic bacterial, fungal or viral infection\n* Active or latent Hepatitis B, Hepatitis C, HIV, or tuberculosis\n* History of demyelinating disease, e.g. Multiple Sclerosis or Guillain-Barre\n* History of heart failure\n* Active liver disease\n* Systemic lupus erythematosus or ANA \\> 1:80\n* History of inflammatory bowel disease, e.g. ulcerative colitis or Crohns disease\n* Cyclophosphamide in past 90 days, Rituximab in the past 180 days\n* Pregnancy or nursing\n* Blood white blood cell count \\<4,500/mm3; Hg \\<9 g/dL; Platelet count \\<150,000/mm3 at enrollment. - Use of an erythropoiesis stimulating agent will not be an exclusion criterion.\n* Concurrent use of interleukin-1 antagonist (Anakinra), other TNF blocking agent, methotrexate or abatacept\n* Diabetes Mellitus'}, 'identificationModule': {'nctId': 'NCT04009668', 'briefTitle': 'Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Precision Medicine Proof of Concept for Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease', 'orgStudyIdInfo': {'id': 'HUM00147018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'adalimumab', 'description': 'Adalimumab dose every other week (study weeks 0, 2, 4, 6, and 8), subcutaneously', 'interventionNames': ['Drug: adalimumab']}], 'interventions': [{'name': 'adalimumab', 'type': 'DRUG', 'otherNames': ['Humira'], 'description': 'Adalimumab will be dosed based on weight', 'armGroupLabels': ['adalimumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'The University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': "Levine Children's Hospital/Atrium Health", 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Zubin Modi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'url': 'http://neptune-study.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'At the latest, data will be shared with the NEPTUNE Data Analysis and Coordinating Center at the time of publication of final results or 24 months after transfer of samples or raw data sets.', 'ipdSharing': 'YES', 'description': 'This trial will follow the publication and data sharing policies of the NEPTUNE study, www.NEPTUNE-study.org\n\nRequest for ancillary studies should be submitted through the project contact and will be reviewed by the project steering committee.\n\nAfter the study is completed, data will be submitted to the Nephrotic Syndrome Study Network (NEPTUNE), an NIH funded consortium. Proposals to access the data will then be submitted via the NEPTUNE Ancillary Studies program (NEPTUNE-study.org). Following closure of NEPTUNE, the trial data will convey with the NEPTUNE date to the NIH/NIDDK repository and can be accessed through this mechanism following approval.', 'accessCriteria': 'While this study is open data requests from this study will need to seek approval from the trial steering committee.\n\nOnce the data is transferred to the NEPTUNE study, all study data will become part of the aggregate NEPTUNE data and available to NEPTUNE participant sites and other requesting third parties upon request. Subsequent access to these data will be governed by the NIH Office of Rare Diseases (ORD) data sharing policies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics, Division of Nephrology', 'investigatorFullName': 'Zubin Juzer Modi', 'investigatorAffiliation': 'University of Michigan'}}}}