Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT01871467
Status:
COMPLETED
Last Update Posted:
2017-08-22
First Post:
2013-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sargramostim for Myeloid Dendritic Cell Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C081222', 'term': 'sargramostim'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-17', 'studyFirstSubmitDate': '2013-06-04', 'studyFirstSubmitQcDate': '2013-06-05', 'lastUpdatePostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target blood myeloid dendritic cell level of > 2.0 x 10<4>/mL', 'timeFrame': '2-4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dendritic Cell Deficiency']}, 'descriptionModule': {'briefSummary': 'Previous studies have demonstrated a deficiency of blood dendritic cells in patients with kidney disease that is associated with the development of viral infections after kidney transplantation. We plan to test the ability of sargramostim to increase blood dendritic cell levels in patients with kidney disease in the hopes of developing new therapies to prevent viral infections after kidney transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years \\< 80 years with diagnosis of end stage renal disease and currently undergoing outpatient hemodialysis (HD) at one of the Johns Hopkins University-affiliated HD units\n\nExclusion Criteria:\n\n* Age\\<18or\\>80years\n* History of non-adherence to prescribed HD treatment\n* Active drug or heavy alcohol use (defined as \\> 4 drinks/day)\n* Pregnancy or breast feeding\n* Active infection (bacterial or viral) or clinically significant infections within the past three months (e.g. those requiring hospitalization, or as judged by the PI)\n* Active malignancy (with the exception of excised non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin, or adequately treated pre- invasive cervical cancer in situ)\n* Unstable cardiovascular status (angina, arrhythmias, congestive heart failure etc...)\n* History of liver disease (as defined by a diagnosis of uncompensated cirrhosis) • History of lung disease (including moderate-severe chronic obstructive pulmonary disease, interstitial lung disease, or asthma)\n* Known hypersensitivity to yeast-derived products\n* Hemoglobin \\< 10 g/dL and hematocrit \\< 30%.\n* Abnormal white blood cell (WBC) count at baseline (\\< 3 or \\> 12 x 10 cells/mm )\n* Treatment with WBC growth factors (G-CSF or GM-CSF) or immunosuppressive medications (tacrolimus, cyclosporine, mycophenolate, azathioprine, corticosteroids, chlorambucil, cyclophosphamide) within 4 weeks of study (erythropoiesis-stimulating agents will be allowed)\n* Treatment with lithium within 4 weeks of study'}, 'identificationModule': {'nctId': 'NCT01871467', 'briefTitle': 'Sargramostim for Myeloid Dendritic Cell Deficiency', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Sargramostim for Myeloid Dendritic Cell Deficiency - Phase I', 'orgStudyIdInfo': {'id': 'KW-5001-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sargramostim administration', 'description': 'Subjects will receive sargramostim.', 'interventionNames': ['Drug: Sargramostim']}], 'interventions': [{'name': 'Sargramostim', 'type': 'DRUG', 'armGroupLabels': ['Sargramostim administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Karl L Womer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}