Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-31 @ 2:09 PM
Study NCT ID:
NCT00807794
Status:
COMPLETED
Last Update Posted:
2008-12-12
First Post:
2008-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety Clinical Trial of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'C544394', 'term': 'siplizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '1998-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-10', 'studyFirstSubmitDate': '2008-12-10', 'studyFirstSubmitQcDate': '2008-12-10', 'lastUpdatePostDateStruct': {'date': '2008-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1997-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the clinical safety of MEDI-507. Each adverse event will be reported by severity grade, relationship to study drug, organ system, and need for medical intervention.', 'timeFrame': 'Day 33'}], 'secondaryOutcomes': [{'measure': 'To collect initial pharmacokinetic parameters, the incidence and time to first episode of acute rejection, the number of episodes of rejection and graft survival.', 'timeFrame': 'Day 33'}]}, 'conditionsModule': {'conditions': ['Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'To evaluate the clinical safety of different doses of MEDI-507 through day 33.', 'detailedDescription': 'To evaluate the pharmacokinetic characteristics of MEDI-507 given in dose intervals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Renal allograft recipients receiving their first or second allograft\n* Age over 18\n* Maintained on conventional immunosuppression\n* Completed informed consent document\n\nExclusion Criteria:\n\n* Known hypersensitivity to MEDI-507\n* More than two renal allografts\n* Moribund and unlikely (in the opinion of the investigator) to survive the duration of the trial\n* Simultaneous use of other investigational agents (this does not include the use of licensed agents for indications not listed in the package insert)\n* Any of the following clinical settings or diagnoses posttransplant:\n\npregnancy or nursing mother: Ø Human Immunodeficiency Virus infection Ø hemodialysis or chronic peritoneal dialysis Ø use of a ventilator Ø hyperacute rejection\n\n* Having received OKT3, tacrolimus, or antilymphocyte globulin during the current allograft\n* Less than 10 ml/hr average urine output over 4 hours since the end of surgery'}, 'identificationModule': {'nctId': 'NCT00807794', 'briefTitle': 'A Safety Clinical Trial of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'Phase I Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection', 'orgStudyIdInfo': {'id': 'MI-CP027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'MEDI-507', 'interventionNames': ['Drug: MEDI-507']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'MEDI-507', 'interventionNames': ['Drug: MEDI-507']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'MEDI-507', 'interventionNames': ['Drug: MEDI-507']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'MEDI-507', 'interventionNames': ['Drug: MEDI-507']}, {'type': 'EXPERIMENTAL', 'label': '5', 'description': 'MEDI-507', 'interventionNames': ['Drug: MEDI-507']}], 'interventions': [{'name': 'MEDI-507', 'type': 'DRUG', 'description': '0.012 mg/kg dose given twice between 60 to 72 hours apart', 'armGroupLabels': ['1']}, {'name': 'MEDI-507', 'type': 'DRUG', 'description': '0.06 mg/kg dose given twice between 60 to 72 hours apart', 'armGroupLabels': ['2']}, {'name': 'MEDI-507', 'type': 'DRUG', 'description': '0.12 mg/kg dose given twice between 60 to 72 hours apart', 'armGroupLabels': ['3']}, {'name': 'MEDI-507', 'type': 'DRUG', 'description': '0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental)', 'armGroupLabels': ['4']}, {'name': 'MEDI-507', 'type': 'DRUG', 'description': '0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental)', 'armGroupLabels': ['5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '47405', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio Community Hospital', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'J. Bruce McClain, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedImmune LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'J. Bruce McClain, M.D.', 'oldOrganization': 'Medimmune Inc.'}}}}