Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT00234702
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2005-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'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': 'C119467', 'term': 'lanthanum carbonate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2007-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-04', 'studyFirstSubmitDate': '2005-10-05', 'studyFirstSubmitQcDate': '2005-10-05', 'lastUpdatePostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum phosphorus levels at 8 weeks.', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'PTH levels, calcium-phosphorus product.', 'timeFrame': '8 weeks'}]}, 'conditionsModule': {'conditions': ['Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '19056618', 'type': 'RESULT', 'citation': 'Sprague SM, Abboud H, Qiu P, Dauphin M, Zhang P, Finn W. Lanthanum carbonate reduces phosphorus burden in patients with CKD stages 3 and 4: a randomized trial. Clin J Am Soc Nephrol. 2009 Jan;4(1):178-85. doi: 10.2215/CJN.02830608. Epub 2008 Dec 3.'}, {'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.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/opacom/7alerts.html', 'label': 'FDA Recall Information'}]}, 'descriptionModule': {'briefSummary': "Chronic kidney disease (CKD) can result in a loss of ability to filter and excrete phosphate. The body's attempt to adjust to an increased level of phosphate in the blood can result in elevated levels of hormones and minerals resulting in serious clinical consequences. This study is being conducted to evaluate the safety and efficacy of lanthanum carbonate in lowering high levels of phosphorus in the blood in subjects with CKD Stages 3 and 4 compared to placebo."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Under a physician's care for CKD for \\> 2 months and are not expected to begin dialysis for 4 months\n* Screening estimated GFR of 15-59 mL/1.73 m2\n* Serum phosphorus \\>= 4.7 mg/d following washout\n\nExclusion Criteria:\n\n* Requiring treatment with cinacalcet HCI or compounds containing phosphate, aluminum, calcium or magnesium\n* Rapidly progressing glomerulonephritis\n* Cirrhosis or other clinically significant liver diseases\n* Past or present uncontrolled peptic ulcer, Crohn's disease, malignancy or recent GI bleed"}, 'identificationModule': {'nctId': 'NCT00234702', 'briefTitle': 'Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase II, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of Lanthanum Carbonate for the Reduction of Serum Phosphorus in Subjects With Stage 3 and 4 Chronic Kidney Disease Who Have Elevated Serum Phosphorus Levels', 'orgStudyIdInfo': {'id': 'SPD405-206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Lanthanum carbonate']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lanthanum carbonate', 'type': 'DRUG', 'otherNames': ['FOSRENOL'], 'description': 'Lanthanum carbonate 750mg/day, T.I.D. for 2 weeks; titrated at the next 3 weekly visits in order to achieve target serum phosphorus levels, up to a maximum dose of 3000mg/day; 4-week maintenance period where subject receives the final titrated daily dose established during the titration period.', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Los Angeles Health Care System', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90503', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Barnett Research & Communications Medical Corporation', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80260', 'city': 'Thornton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Western Nephrology & Metabolic Bone Disease, PC', 'geoPoint': {'lat': 39.86804, 'lon': -104.97192}}, {'zip': '34667', 'city': 'Hudson', 'state': 'Florida', 'country': 'United States', 'facility': 'Outcomes Research International, Inc.', 'geoPoint': {'lat': 28.36445, 'lon': -82.69343}}, {'zip': '55430', 'city': 'Brooklyn Center', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Twin Cities Clinical Research', 'geoPoint': {'lat': 45.07608, 'lon': -93.33273}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University/Nephrology', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Northwest Renal Clinic', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Nephrology Associates', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Kidney Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}