Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT01893658
Status:
WITHDRAWN
Last Update Posted:
2018-12-06
First Post:
2013-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C564356', 'term': 'Acute Tubulointerstitial Nephritis'}, {'id': 'D009395', 'term': 'Nephritis, Interstitial'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'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': 'D000069444', 'term': 'Omalizumab'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D000888', 'term': 'Antibodies, Anti-Idiotypic'}, {'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': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of patients with a condition of interest that resulted in failure to recruit', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-04', 'studyFirstSubmitDate': '2013-06-12', 'studyFirstSubmitQcDate': '2013-07-02', 'lastUpdatePostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum creatinine', 'timeFrame': 'Baseline to three months'}], 'secondaryOutcomes': [{'measure': 'Mean individual percentage drop in serum creatinine relative to entry creatinine levels', 'timeFrame': 'baseline to 3 months'}, {'measure': 'Percentage of subjects returning to their usual baseline creatinine (+25%) or below', 'timeFrame': 'baseline to 3 months'}, {'measure': 'Reduction in Neutrophil gelatinase-associated lipocalcin.', 'timeFrame': 'baseline to 3 months', 'description': '24 hours, 4 hours, and in 3 months after Xolair treatment'}, {'measure': 'Percentage of subjects requiring renal replacement therapy', 'timeFrame': 'baseline to 3 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interstitial Nephritis', 'Nephritis', 'Tubulointerstitial', 'Renal disease', 'Kidney'], 'conditions': ['Acute Interstitial Nephritis']}, 'descriptionModule': {'briefSummary': 'The investigators goal is to evaluate the role of XOLAIR® in treatment of Acute Tubulointerstitial Nephritis (AIN) with the goal of shortening the duration and dose of prednisone for treatment of drug-induced AIN. Currently there is no good treatment for drug-induced AIN. Prednisone is the standard treatment but is associated with many side-effects when used long-term and at high doses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult subjects \\> 18 years old of both genders\n2. Biopsy proven acute interstitial nephritis in the native kidneys without evidence of ischemic or glomerular pathology in the biopsy\n3. Normal baseline creatinine defined as estimated GFR ≥ 60 ml/min/SA based on MDRD calculation within 1 year prior to renal biopsy\n4. Serum creatinine elevation of \\> 0.3 mg/dL and/or doubling of serum creatinine compared to most recent documented creatinine available (at least within the last year)\n5. No immunosuppressants in the last three months including prednisone\n6. Women of childbearing potential not using the contraception method can be included as this is a one time dosing and has no known long-term effects.\n\nExclusion Criteria:\n\n1. Unwillingness to give consent\n2. Patients who are Pregnant (positive serum pregnancy test for females) or breast feeding\n3. Documented history of an autoimmune disease\n4. Inability or unwillingness to take prednisone for the prescribed duration and/or dose\n5. Subjects suspected to have non-drug-induced AIN\n6. Subjects not meeting the inclusion criteria\n7. Subjects with contraindication to administration of omalizumab\n8. Prior use of omalizumab\n9. Severe hypersensitivity to omalizumab or any component of the product\n10. Known elevated IgE level from other disease processes\n11. Subjects taking (nonsteroidal antiinflammatory drug) NSAIDs chronically\n12. Use of any other investigational agents in the last 30 days\n13. Patients with severe medical condition(s) including metastatic cancer, terminal congestive heart failure, severe ischemic heart disease or any other medical condition in which life expectancy is less than 6 months.'}, 'identificationModule': {'nctId': 'NCT01893658', 'briefTitle': 'Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)', 'orgStudyIdInfo': {'id': '12-006797'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Omalizumab and Prednisone', 'description': 'Omalizumab in addition to prednisone. Omalizumab will be given once subcutaneously at a dose of 375 mg within 24 hours after receiving prednisone\n\nStandard clinical therapy with prednisone.\n\n* Day 1-14: 60 mg/day 14 days (2 weeks)\n* Day 15-28: 40 mg/day (2 weeks)\n* Day 29-35: 30 mg/day (1 week)\n* Day 36-42: 20 mg/day (1 week)\n* Day 43-49: 10 mg/day (1 week)\n* Day 50-56: 5 mg/day (1 week)\n* Subjects will stop taking prednisone on day 57\n\nIf patients weigh less than 60 Kg, the dose will be adjusted accordingly (to equal 1mg/kg/day of prednisone as the starting dose).', 'interventionNames': ['Drug: Omalizumab', 'Drug: Prednisone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prednisone', 'description': 'Standard clinical therapy with prednisone.\n\n* Day 1-14: 60 mg/day 14 days (2 weeks)\n* Day 15-28: 40 mg/day (2 weeks)\n* Day 29-35: 30 mg/day (1 week)\n* Day 36-42: 20 mg/day (1 week)\n* Day 43-49: 10 mg/day (1 week)\n* Day 50-56: 5 mg/day (1 week)\n* Subjects will stop taking prednisone on day 57\n\nIf patients weigh less than 60 Kg, the dose will be adjusted accordingly (to equal 1mg/kg/day of prednisone as the starting dose).', 'interventionNames': ['Drug: Prednisone']}], 'interventions': [{'name': 'Omalizumab', 'type': 'DRUG', 'otherNames': ['Xolair'], 'description': 'administration of a single dose together with the standard treatment', 'armGroupLabels': ['Omalizumab and Prednisone']}, {'name': 'Prednisone', 'type': 'DRUG', 'otherNames': ['Prednisolone'], 'description': 'standard treatment', 'armGroupLabels': ['Omalizumab and Prednisone', 'Prednisone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Vesna D. Garovic, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Vesna D. Garovic, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}