Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-01-19 @ 9:46 AM
Study NCT ID:
NCT06690450
Status:
COMPLETED
Last Update Posted:
2024-11-15
First Post:
2019-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of 200mg and 100mg of Venofer Administered to Hemodialysis(HD) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077605', 'term': 'Ferric Oxide, Saccharated'}], 'ancestors': [{'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005937', 'term': 'Glucaric Acid'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2002-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2019-02-07', 'studyFirstSubmitQcDate': '2024-11-13', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2002-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v4.0', 'timeFrame': '3 to 6 days', 'description': 'Any untoward medical events were elicited by nonspecific questions such as "Have you noticed any problems".'}], 'secondaryOutcomes': [{'measure': 'The number of participants prematurely discontinued the study due to an adverse event', 'timeFrame': '3 to 6 days', 'description': 'The investigator determined whether any adverse event warranted removal of a subject from the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hemodialysis']}, 'descriptionModule': {'briefSummary': 'The Objective of this study is to assess the Safety and Tolerability of 200 mg and 100 mg of Venofer Administered to Hemodialysis(HD) Patients.', 'detailedDescription': 'This is a randomized open label multi-center study of two parallel patient groups undergoing hemodialysis. Group A will receive 200 mg of iron sucrose, while Group B will receive 100 mg of iron sucrose during the study. The duration of the study for each patient will be approximately 3 weeks including a screening phase, a treatment visit and a follow-up visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females over 18 years of age and able to give informed consent.\n* Undergoing hemodialysis.\n* If receiving epoetin α, then the dose was stable.\n* Percentage serum transferrin saturation (TSAT) \\<50% and serum ferritin \\<800 ng/mL.\n* Absence of infection, malignancy, or surgery in the month prior to study start.\n* Intolerance of other iron products did not preclude participation in this study.\n\nExclusion Criteria:\n\n* Known sensitivity to any component of Venofer®.\n* Suffering from concomitant severe diseases of the liver, cardiovascular system, severe psychiatric disorders or other conditions which, in the opinion of the investigator, made participation unacceptable.\n* Serious bacterial, viral infection, or other acute infectious illness (e.g., hepatitis) unless completely resolved at least 4 weeks prior to inclusion in the study.\n* Pregnancy or lactation.\n* HIV positive by medical history or laboratory test (optional), or active hepatitis.\n* Anemia caused by diseases (including systemic lupus erythematosus (SLE), rheumatoid arthritis, myeloma, or hereditary hemoglobinopathies) other than chronic renal failure or iron deficiency.\n* Asthma.\n* Clinical evidence of gastrointestinal bleeding.\n* Would probably require blood transfusion or might undergo a renal transplant during the study.\n* Anticipated surgery of any kind during the study other than vascular access surgery.\n* Received an investigational drug within 30 days prior to screening.\n* Previously participated in another Venofer® study.'}, 'identificationModule': {'nctId': 'NCT06690450', 'briefTitle': 'Safety and Tolerability of 200mg and 100mg of Venofer Administered to Hemodialysis(HD) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'American Regent, Inc.'}, 'officialTitle': 'A Randomized Study to Assess the Safety and Tolerability of 200mg and 100mg of Venofer Administered to Hemodialysis (HD) Patients', 'orgStudyIdInfo': {'id': '1VEN01015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Venofer® 200 mg', 'description': 'A single 200 mg dose of Venofer® administered by slow intravenous push over 5 minutes.', 'interventionNames': ['Drug: Venofer® 200 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Venofer® 100 mg', 'description': 'A single 100 mg dose of Venofer® administered by slow intravenous push over 2 minutes without a test dose', 'interventionNames': ['Drug: Venofer® 100 mg']}], 'interventions': [{'name': 'Venofer® 200 mg', 'type': 'DRUG', 'otherNames': ['Iron sucrose'], 'description': 'A single 200 mg dose of Venofer® administered by slow intravenous push over 5 minutes', 'armGroupLabels': ['Venofer® 200 mg']}, {'name': 'Venofer® 100 mg', 'type': 'DRUG', 'otherNames': ['Iron sucrose'], 'description': 'A single 100 mg dose of Venofer® administered by slow intravenous push over 2 minutes without a test dose.', 'armGroupLabels': ['Venofer® 100 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Carol Duffy, D.O.,FACC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Director'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American Regent, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}