Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT00354692
Status:
COMPLETED
Last Update Posted:
2012-08-14
First Post:
2006-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Two Iron Preparations on Protein in the Urine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C035552', 'term': 'ferric gluconate'}, {'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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'lastUpdateSubmitDate': '2012-08-10', 'studyFirstSubmitDate': '2006-07-18', 'studyFirstSubmitQcDate': '2006-07-18', 'lastUpdatePostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in urine protein', 'timeFrame': '180 minutes'}], 'secondaryOutcomes': [{'measure': 'Change in various urine chemicals', 'timeFrame': '180 minutes'}]}, 'conditionsModule': {'conditions': ['Kidney Failure, Chronic', 'Anemia, Iron-Deficiency']}, 'referencesModule': {'references': [{'pmid': '17622274', 'type': 'RESULT', 'citation': 'Agarwal R, Rizkala AR, Kaskas MO, Minasian R, Trout JR. Iron sucrose causes greater proteinuria than ferric gluconate in non-dialysis chronic kidney disease. Kidney Int. 2007 Sep;72(5):638-42. doi: 10.1038/sj.ki.5002422. Epub 2007 Jul 11.'}]}, 'descriptionModule': {'briefSummary': 'This pilot study will compare the effects of sodium ferric gluconate complex and iron sucrose on urine concentrations of various chemicals including protein'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe anemia\n* Iron deficiency\n* Moderate to severe chronic kidney disease\n* Age ≥ 18 or greater and able to give informed consent\n\nExclusion Criteria:\n\n* Receiving dialysis\n* Known sensitivity to Sodium Ferric Gluconate Complex in Sucrose Injection, Iron sucrose USP, or any of their components\n* Clinically unstable\n* Indication of iron sufficiency'}, 'identificationModule': {'nctId': 'NCT00354692', 'briefTitle': 'Effect of Two Iron Preparations on Protein in the Urine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Watson Pharmaceuticals'}, 'officialTitle': 'A Randomized Cross-over Pilot Study of the Effect of Sodium Ferric Gluconate Complex vs. Iron Sucrose on Proteinuria in Non-dialysis Chronic Kidney Disease Patients', 'orgStudyIdInfo': {'id': 'FER0601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'interventionNames': ['Drug: Sodium Ferric Gluconate and Iron sucrose']}], 'interventions': [{'name': 'Sodium Ferric Gluconate and Iron sucrose', 'type': 'DRUG', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Glendale', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}], 'overallOfficials': [{'name': 'Adel R. Rizkala, Pharm.D., MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Watson Laboratories, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Watson Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}