Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-03-05 @ 4:27 PM
Study NCT ID:
NCT01864161
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
2013-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endovenous Versus Liposomal Iron in CKD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C043193', 'term': 'ferlixit'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-23', 'studyFirstSubmitDate': '2013-05-24', 'studyFirstSubmitQcDate': '2013-05-28', 'lastUpdatePostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modification in hemoglobin levels', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Iron Deficiency Anemia', 'Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': "Anemia is a common complication in patients with chronic kidney disease (CKD). In addition to erythropoietin deficiency, many studies have identified iron deficiency as a cause of anemia in CKD patients. Most patients with CKD are iron deficient because of: inadequate intake and absorption, gastroenteric bleeding, urinary iron loss in patient with significant proteinuria. The iron treatment is pivotal to manage anemic patients with CKD: the prescription of iron is usually oral because of practicality and safety, but often it is inevitable to administer intravenous iron because of gastroenteric malabsorption, intolerance to oral administration, irregular intake. There're few randomized controlled studies about the efficacy of oral iron versus intravenous iron in patients not on dialysis; most of them demonstrate superiority of intravenous therapy to restore iron deficiency and hemoglobin levels. A particular formulation of iron, liposomal iron has a high gastroenteric absorption and high bioavailability with lower incidence of side effects. The investigators study aims to evaluate the efficacy of treatment with liposomal oral iron compared to intravenous iron in CKD anemic patients not on dialysis in the presence of iron deficiency."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Signed written informed consent;\n* Glomerular filtration rate (GFR) ≤ 60 mL/min (MDRD GFR calculated according to 4 variables);\n* hemoglobin ≤ 12g/dL;\n* Ferritin ≤ 100ng/mL with transferrin saturation (TSAT) ≤ 25%;\n* If erythropoiesis stimulating agents (ESA) therapy, stable dose for at least three months;\n\nExclusion Criteria:\n\n* Infectious diseases;\n* bleeding in the preceding six months;\n* History of malignancy tumor in the last 3 years;\n* Anemia case different from that resulting from CKD;\n* vitamin B12 and folate deficiency;\n* Surgery of any kind in the last three months;\n* systemic haematological disease;\n* Blood Transfusions, therapy with intravenous or oral iron in the last three months;\n* Severe liver disease / test positive for hepatitis C virus (HCV) and hepatitis B virus (HBV);\n* Abuse of alcohol and drugs in the preceding six months;\n* immunosuppressive therapy ;\n* Significant weight loss;\n* Pregnancy or breast-feeding.'}, 'identificationModule': {'nctId': 'NCT01864161', 'briefTitle': 'Endovenous Versus Liposomal Iron in CKD', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'orgStudyIdInfo': {'id': 'BIANCA79'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oral liposomal iron', 'description': 'patients receive a dose of liposomal 30 mg/die iron (equivalent to 1 cp Sideral forte).', 'interventionNames': ['Drug: Liposomal iron']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'endovenous iron', 'description': 'patients receive a total dose 1000 mg of intravenous iron gluconate divided into administrations of 125 mg diluted in 250 mL normal saline infused weekly for 3 months', 'interventionNames': ['Drug: gluconate iron']}], 'interventions': [{'name': 'gluconate iron', 'type': 'DRUG', 'otherNames': ['FERLIXIT'], 'description': 'FERLIXIT fl 15mg/kg divided into weekly administrations of 125mg up to a maximum of 1000mg', 'armGroupLabels': ['endovenous iron']}, {'name': 'Liposomal iron', 'type': 'DRUG', 'otherNames': ['Sideral forte'], 'description': 'Sideral forte 30 mg/die', 'armGroupLabels': ['oral liposomal iron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'state': 'Naples', 'country': 'Italy', 'facility': 'Federico II University', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Eleonora Riccio', 'investigatorAffiliation': 'Federico II University'}}}}