Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-01 @ 7:15 AM
Study NCT ID:
NCT01069692
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2010-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054559', 'term': 'Hyperphosphatemia'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D010760', 'term': 'Phosphorus 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'dispFirstSubmitDate': '2020-08-20', 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2010-02-15', 'dispFirstSubmitQcDate': '2020-08-20', 'studyFirstSubmitQcDate': '2010-02-16', 'dispFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment', 'timeFrame': '6 weeks'}, {'measure': 'Evaluate dose-dependent efficacy of SBR759', 'timeFrame': '6 weeks'}, {'measure': 'Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo', 'timeFrame': '6 weeks'}]}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease', 'Hemodialysis', 'Hyperphosphatemia', 'Hyperphosphatemia patients with chronic kidney disease on 3x/week hemodialysis'], 'conditions': ['Hyperphosphatemia', 'Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '40576086', 'type': 'DERIVED', 'citation': 'Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.'}, {'pmid': '23670305', 'type': 'DERIVED', 'citation': 'Fukagawa M, Kasuga H, Joseph D, Sawata H, Junge G, Moore A, Akiba T. Efficacy and safety of SBR759, a novel calcium-free, iron (III)-based phosphate binder, versus placebo in chronic kidney disease stage V Japanese patients on maintenance renal replacement therapy. Clin Exp Nephrol. 2014 Feb;18(1):135-43. doi: 10.1007/s10157-013-0815-7. Epub 2013 May 15.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4647', 'label': 'Results for CSBR759A2304 from the Novartis Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Men or women of at least 18 years of age\n2. Stable maintenance of hemodialysis 3 times per week for 3 months or greater\n3. Controlled serum phosphate if under phosphate-binder therapy\n4. Patient must either be on a stable phosphate binder dose and are willing to stop their phosphate binder therapy at the beginning of the study, or not have received any phosphate binder therapy for at least 4 weeks prior to screening\n\nExclusion criteria:\n\n1. Patients who are on peritoneal dialysis\n2. Patients who have a transplant or parathyroidectomy scheduled during the study\n3. Clinically significant GI disorder\n4. Unstable medical condition other than Chronic Kidney Disease\n5. Patient is currently being treated with oral iron\n6. History of hemachromatosis, or ferritin \\> 1000 ng/mL\n7. Transferrin saturation \\> 60%\n8. Uncontrolled hyperparathyroidism (iPTH \\> 84.8 pmol/L) Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01069692', 'acronym': 'SBR759', 'briefTitle': 'Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled Multi-center Trial to Compare the Phosphate Lowering Efficacy of Different Doses of SBR759 to Placebo', 'orgStudyIdInfo': {'id': 'CSBR759A2304'}, 'secondaryIdInfos': [{'id': '2008-006097-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 1', 'description': 'Placebo', 'interventionNames': ['Drug: SBR759A']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'interventionNames': ['Drug: SBR759A']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'interventionNames': ['Drug: SBR759A']}, {'type': 'EXPERIMENTAL', 'label': 'arm 4', 'description': 'SBR759A', 'interventionNames': ['Drug: SBR759A']}, {'type': 'EXPERIMENTAL', 'label': 'arm 5', 'interventionNames': ['Drug: SBR759A']}], 'interventions': [{'name': 'SBR759A', 'type': 'DRUG', 'description': 'SBR759A 6g daily', 'armGroupLabels': ['Arm 3']}, {'name': 'SBR759A', 'type': 'DRUG', 'description': 'Placebo Comparator 0g daily', 'armGroupLabels': ['Arm 1']}, {'name': 'SBR759A', 'type': 'DRUG', 'description': 'SBR759A 3g daily', 'armGroupLabels': ['Arm 2']}, {'name': 'SBR759A', 'type': 'DRUG', 'description': '9g daily', 'armGroupLabels': ['arm 4']}, {'name': 'SBR759A', 'type': 'DRUG', 'description': '12g daily', 'armGroupLabels': ['arm 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '8800', 'city': 'Roeselare', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'zip': '25123', 'city': 'Brescia', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '23900', 'city': 'Lecco', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.85589, 'lon': 9.39704}}, {'zip': '55100', 'city': 'Lucca', 'country': 'Italy', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 43.84369, 'lon': 10.50447}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '53100', 'city': 'Siena', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}], 'overallOfficials': [{'name': 'Novartis Pharmceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis Pharmaceuticals'}}}}