Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-01-01 @ 6:38 AM
Study NCT ID:
NCT00318812
Status:
COMPLETED
Last Update Posted:
2016-05-10
First Post:
2006-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dzimmerman@toh.on.ca', 'phone': '613-738-8400', 'title': 'Dr Deborah Zimmerman, principal investigator', 'phoneExt': '82534', 'organization': 'Ottawa Hospital Research Institute'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Recruitment for the trial was a challenge; over 1100 patients screened - 55 consented - 40 randomized'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Heme Iron', 'description': 'Heme Iron Polypeptide 11mg PO tid for 6 months', 'otherNumAtRisk': 18, 'otherNumAffected': 5, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Iron Sucrose', 'description': 'Iron Sucrose q month IV x 6 months', 'otherNumAtRisk': 22, 'otherNumAffected': 4, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'constipation', 'notes': 'Gastrointestinal complaints were the most common adverse effects in both groups with constipation and abdominal cramps being the most common in HIP group and constipation in IV sucrose group', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Hip iron'}, {'term': 'abdominal cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Hip'}, {'term': 'Symptomatic Hypotension', 'notes': 'symptomatic hypotesnion was seen in 3 patients in the IV sucrose arm and 0 patients in the HIP arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'IV surcrose'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Hip iron'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Hip iron'}, {'term': 'Skin Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Hip iron'}, {'term': 'Muscle cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Hip iron'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hemoglobin Concentration at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Heme Iron', 'description': 'Heme Iron Polypeptide 11mg PO tid for 6 months'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron Sucrose q month IV x 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000', 'lowerLimit': '110', 'upperLimit': '129'}, {'value': '113', 'groupId': 'OG001', 'lowerLimit': '108', 'upperLimit': '120'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'g/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ferritin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Heme Iron', 'description': 'Heme Iron Polypeptide 11mg PO tid for 6 months'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron Sucrose q month IV x 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '104'}, {'value': '244', 'groupId': 'OG001', 'lowerLimit': '72', 'upperLimit': '298'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Comparison of Ferritin at 6 months between the 2 Groups', 'unitOfMeasure': 'ug/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Transferrin Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Heme Iron', 'description': 'Heme Iron Polypeptide 11mg PO tid for 6 months'}, {'id': 'OG001', 'title': 'Iron Sucrose', 'description': 'Iron Sucrose q month IV x 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '29'}, {'value': '21.5', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 Months', 'description': 'Comparison of Transferrin Saturation between the Groups', 'unitOfMeasure': 'percentage of bound iron sites', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Heme Iron', 'description': 'Heme Iron Polypeptide 11mg PO tid for 6 months'}, {'id': 'FG001', 'title': 'Iron Sucrose', 'description': 'Iron Sucrose q month IV x 6 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'May 2007 - February 2011, 55 Chronic Kidney Disease patients \\>18years,with an estimated Glomerular Filtration Rate (eGFR) \\<30mls/minute and Hemoglobin (Hgb) of 90-110 were recruited. Recruitment was expanded to eGFR ≤60 and Hgb of 90-120g/L (females)and 90-135 g/L (males) with serum ferritin \\< 100 mcg /L or Transferrin Saturation (TSAT) \\< 20%)', 'preAssignmentDetails': '15 of the 55 patients were screen failures due to; Hgb too high/low, ferritin level too high, Vitamin B level too low,one had bypass surgery'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Heme Iron', 'description': 'Heme Iron Polypeptide 11mg PO tid for 6 months'}, {'id': 'BG001', 'title': 'Iron Sucrose', 'description': 'Iron Sucrose q month IV x 6 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000', 'lowerLimit': '66', 'upperLimit': '83'}, {'value': '66', 'groupId': 'BG001', 'lowerLimit': '58', 'upperLimit': '76'}, {'value': '68', 'groupId': 'BG002', 'lowerLimit': '63', 'upperLimit': '77'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-05', 'studyFirstSubmitDate': '2006-04-25', 'resultsFirstSubmitDate': '2013-06-26', 'studyFirstSubmitQcDate': '2006-04-25', 'lastUpdatePostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-02', 'studyFirstPostDateStruct': {'date': '2006-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin Concentration at 6 Months', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Ferritin', 'timeFrame': '6 months', 'description': 'Comparison of Ferritin at 6 months between the 2 Groups'}, {'measure': 'Transferrin Saturation', 'timeFrame': '6 Months', 'description': 'Comparison of Transferrin Saturation between the Groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Randomized controlled trial (RCT)', 'Prospective Studies', 'ferric oxide, saccharated', 'Peptides', 'Heme', 'Iron', 'Erythropoietin,', 'Recombinant', 'Ferritin', 'Transferrin', 'Treatment Outcome'], 'conditions': ['Anemia', 'Renal Failure']}, 'referencesModule': {'references': [{'pmid': '23514036', 'type': 'DERIVED', 'citation': 'Nagaraju SP, Cohn A, Akbari A, Davis JL, Zimmerman DL. Heme iron polypeptide for the treatment of iron deficiency anemia in non-dialysis chronic kidney disease patients: a randomized controlled trial. BMC Nephrol. 2013 Mar 20;14:64. doi: 10.1186/1471-2369-14-64.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if oral Heme Iron Polypeptide is as effective as intravenous (IV) iron sucrose in the treatment of iron-deficiency anemia for patients with chronic kidney disease.', 'detailedDescription': 'Iron deficiency anemia is common in patients with pre-dialysis chronic kidney disease, and is associated with significant morbidity. Conventional treatment with oral iron salts or IV iron formulations are costly and are associated with side effects. Heme iron polypeptide is a newly available formulation of oral iron which can be administered orally, is well absorbed by uremic patients, and has potentially fewer side effects.\n\nComparison: Iron deficient anemic patients will be randomized to either oral heme iron polypeptide or IV iron sucrose for six months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* eGFR \\< 30 mL/min\n* Hb 90-110 g/L\n* Age \\> 18\n* Not on renal replacement therapy\n* Transferrin saturation \\< 20% OR Ferritin \\<100 mcg/L\n* B12 \\& folate within reference range\n\nExclusion Criteria:\n\n1. Iron overload (Tsat \\> 50% or ferritin \\> 800 μg/L);\n2. malignancy; recurrent gastro-intestinal bleeding, major surgery or infection within the last 3 months;\n3. parenteral iron therapy, blood transfusion within the last 3 months;\n4. pregnancy;\n5. contraindication to any study medication and;\n6. inability or refusal to give consent.'}, 'identificationModule': {'nctId': 'NCT00318812', 'briefTitle': 'Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Heme Iron Polypeptide for the Treatment of Iron Deficiency Anemia in Pre-Dialysis Patients: A Pilot Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2005840-01H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Heme Iron', 'description': 'Heme Iron Polypeptide 11mg PO tid for 6 months', 'interventionNames': ['Drug: Heme Iron Polypeptide (Proferrin)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Venofer', 'description': 'Venofer q month IV x 6 months', 'interventionNames': ['Drug: Iron sucrose (Venofer)']}], 'interventions': [{'name': 'Heme Iron Polypeptide (Proferrin)', 'type': 'DRUG', 'otherNames': ['Proferrin'], 'description': 'Heme iron polypeptide 11mg po tid for 6 months', 'armGroupLabels': ['Heme Iron']}, {'name': 'Iron sucrose (Venofer)', 'type': 'DRUG', 'otherNames': ['Venofer'], 'description': 'Iron sucrose infusion IV q month x 6 months', 'armGroupLabels': ['Venofer']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H 7W9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital Research Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Deborah Zimmerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Hospital Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}