Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-30 @ 4:12 AM
Study NCT ID:
NCT00438932
Status:
COMPLETED
Last Update Posted:
2011-09-27
First Post:
2007-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low Phosphate Diets in Patients With Early Stages of Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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': 'C119467', 'term': 'lanthanum carbonate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tisakova@med.miami.edu', 'phone': '305-243-4374', 'title': 'Tamara Isakova, MD, MMSc', 'organization': 'University of Miami Miller School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'In addition to limited power, the small sample size led to imbalances in baseline laboratory tests, which added further variability to the analyses. .'}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Lanthanum Carbonate & Low Phosphorous Diet', 'description': 'Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lanthanum Carbonate & Unrestricted Phosphorous Diet', 'description': 'Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo & Low Phosphorous Diet', 'description': 'Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo & Unrestricted Phosphorous Diet', 'description': 'Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fibroblast Growth Factor 23 (FGF-23)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanthanum Carbonate & Low Phosphorous Diet', 'description': 'Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.'}, {'id': 'OG001', 'title': 'Lanthanum Carbonate & Unrestricted Phosphorous Diet', 'description': 'Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.'}, {'id': 'OG002', 'title': 'Placebo & Low Phosphorous Diet', 'description': 'Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.'}, {'id': 'OG003', 'title': 'Placebo & Unrestricted Phosphorous Diet', 'description': 'Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '162.695', 'spread': '56.170737', 'groupId': 'OG000'}, {'value': '297', 'spread': '77.69778', 'groupId': 'OG001'}, {'value': '188.975', 'spread': '60.2020815', 'groupId': 'OG002'}, {'value': '143.7675', 'spread': '37.507486', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Plasma FGF-23 was measured using c-terminal FGF23 assay.', 'unitOfMeasure': 'RU/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '24-hour Urinary Phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanthanum Carbonate & Low Phosphorous Diet', 'description': 'Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.'}, {'id': 'OG001', 'title': 'Lanthanum Carbonate & Unrestricted Phosphorous Diet', 'description': 'Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.'}, {'id': 'OG002', 'title': 'Placebo & Low Phosphorous Diet', 'description': 'Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.'}, {'id': 'OG003', 'title': 'Placebo & Unrestricted Phosphorous Diet', 'description': 'Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '150.4', 'spread': '49.3063045', 'groupId': 'OG000'}, {'value': '382.725', 'spread': '7.0577825', 'groupId': 'OG001'}, {'value': '346.8', 'spread': '132.671329', 'groupId': 'OG002'}, {'value': '830.25', 'spread': '220.003449', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'from 24-hr urine collections', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lanthanum Carbonate & Low Phosphorous Diet', 'description': 'Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.'}, {'id': 'FG001', 'title': 'Lanthanum Carbonate & Unrestricted Phosphorous Diet', 'description': 'Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.'}, {'id': 'FG002', 'title': 'Placebo & Low Phosphorous Diet', 'description': 'Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.'}, {'id': 'FG003', 'title': 'Placebo & Unrestricted Phosphorous Diet', 'description': 'Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '16 patients completed the full study. Patients were recruited from renal clinics.', 'preAssignmentDetails': 'There was no wash-out, run in or transition.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Lanthanum Carbonate & Low Phosphorous Diet', 'description': 'Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.'}, {'id': 'BG001', 'title': 'Lanthanum Carbonate & Unrestricted Phosphorous Diet', 'description': 'Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.'}, {'id': 'BG002', 'title': 'Placebo & Low Phosphorous Diet', 'description': 'Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.'}, {'id': 'BG003', 'title': 'Placebo & Unrestricted Phosphorous Diet', 'description': 'Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'spread': '11', 'groupId': 'BG000'}, {'value': '62', 'spread': '13', 'groupId': 'BG001'}, {'value': '56', 'spread': '21', 'groupId': 'BG002'}, {'value': '68', 'spread': '17', 'groupId': 'BG003'}, {'value': '62', 'spread': '15', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Fibroblast Growth Factor 23 (FGF-23)', 'classes': [{'categories': [{'measurements': [{'value': '164.3', 'spread': '110.9', 'groupId': 'BG000', 'lowerLimit': '77', 'upperLimit': '252'}, {'value': '263.1', 'spread': '167.9', 'groupId': 'BG001', 'lowerLimit': '158', 'upperLimit': '368'}, {'value': '178.8', 'spread': '97.6', 'groupId': 'BG002', 'lowerLimit': '103', 'upperLimit': '254'}, {'value': '121.8', 'spread': '60.0', 'groupId': 'BG003', 'lowerLimit': '85', 'upperLimit': '158'}, {'value': '182.0', 'spread': '116.3', 'groupId': 'BG004', 'lowerLimit': '95', 'upperLimit': '223'}]}]}], 'paramType': 'MEAN', 'description': 'Plasma FGF-23 at the baseline visit was measured using C-terminal FGF23 assay.', 'unitOfMeasure': 'Ru/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '24-hr urine phosphate', 'classes': [{'categories': [{'measurements': [{'value': '659.0', 'spread': '269.8', 'groupId': 'BG000', 'lowerLimit': '491', 'upperLimit': '827'}, {'value': '761.8', 'spread': '77.4', 'groupId': 'BG001', 'lowerLimit': '704', 'upperLimit': '820'}, {'value': '745.4', 'spread': '287.0', 'groupId': 'BG002', 'lowerLimit': '503', 'upperLimit': '988'}, {'value': '934.6', 'spread': '545.5', 'groupId': 'BG003', 'lowerLimit': '607', 'upperLimit': '1262'}, {'value': '775.2', 'spread': '320.0', 'groupId': 'BG004', 'lowerLimit': '564', 'upperLimit': '889'}]}]}], 'paramType': 'MEAN', 'description': 'measured from 24 hour urine collections; 2 separate collections were obtained; values are means of the two collections; pre-intervention', 'unitOfMeasure': 'mg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-23', 'studyFirstSubmitDate': '2007-02-20', 'resultsFirstSubmitDate': '2011-07-25', 'studyFirstSubmitQcDate': '2007-02-21', 'lastUpdatePostDateStruct': {'date': '2011-09-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-23', 'studyFirstPostDateStruct': {'date': '2007-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fibroblast Growth Factor 23 (FGF-23)', 'timeFrame': '2 weeks', 'description': 'Plasma FGF-23 was measured using c-terminal FGF23 assay.'}], 'secondaryOutcomes': [{'measure': '24-hour Urinary Phosphate', 'timeFrame': '2 weeks', 'description': 'from 24-hr urine collections'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['phosphate, phosphorus, FGF-23, PTH, 1,25D'], 'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '20631407', 'type': 'RESULT', 'citation': 'Isakova T, Gutierrez OM, Smith K, Epstein M, Keating LK, Juppner H, Wolf M. Pilot study of dietary phosphorus restriction and phosphorus binders to target fibroblast growth factor 23 in patients with chronic kidney disease. Nephrol Dial Transplant. 2011 Feb;26(2):584-91. doi: 10.1093/ndt/gfq419. Epub 2010 Jul 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn more about how the kidneys control the blood levels of phosphorus in patients with early chronic kidney disease. The ultimate goal is to use this information to design improved treatment strategies for phosphorus-related problems for the millions of patients with chronic kidney disease.', 'detailedDescription': 'Phosphorus is a mineral found in dairy products, nuts, and meat that is essential for bone health and many other important functions inside the body\'s cells. The kidneys are responsible for keeping the blood levels of phosphorus normal. Healthy kidneys do this by spilling excess phosphorus into the urine. In patients with chronic kidney disease, the kidneys are unable to spill an adequate amount of phosphorus so that excess phosphorus can accumulate in the walls of blood vessels leading to heart disease, their leading cause of death. A recently discovered hormone called FGF-23 helps control the blood levels of phosphorus by "telling" the kidney how much phosphorus to spill in the urine. The purpose of this study is to learn more about how FGF-23 helps the kidneys control the blood levels of phosphorus. The ultimate goal is to use this information to design improved treatment strategies for phosphorus-related problems for the millions of patients with chronic kidney disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* subjects with stage 3a, 3b and 4 CKD\n* subjects have to be aged 18 years or older\n* subjects have to have normal serum phosphate levels (\\< 4.6 mg/dl)\n* subjects have to have sufficient 25-OH Vit0amin D levels (≥ 20 ng/ml)\n\nExclusion Criteria:\n\n* subjects with rapidly advancing renal failure who thus might develop hyperphosphatemia or end stage renal disease requiring initiation of dialysis during the study period\n* subjects expected to require dialysis initiation within the follow up period\n* subjects with hyperphosphatemia \\> 4.6 mg/dL\n* subjects with any previous or current treatment with phosphate binders or active vitamin D (doxercalciferol or calcitriol)\n* subjects with malnutrition, defined as a serum albumin \\< 3.0 mg/dl, in order to avoid worsening protein-malnutrition status during the restricted study period since phosphate restricted diets are also low in protein\n* subjects with chronic gastrointestinal diseases that could impede their absorptive ability such as Crohn's disease, ulcerative colitis and sprue\n* subjects with liver disease (ALT or AST \\> 100 U/L) or cholestasis (direct bilirubin \\> 1.0 mg/dl) because this can limit their ability to absorb fat soluble vitamins such as vitamin D\n* subjects with anemia, defined as a hematocrit \\<27% at the screening visit\n* subjects wht have been hospitalization within the previous 4 weeks\n* subjects who are pregnant\n* subjects who are breastfeeding mothers\n* subjects with primary hypoparathyroidism\n* subjects with primary hyperparathyroidism\n* subjects with previous subtotal parathyroidectomy\n* subjects with previous outpatient counseling by a renal nutritionist\n* subjects who are unable to independently provide written informed consent - prisoners, mentally incompetent, minors"}, 'identificationModule': {'nctId': 'NCT00438932', 'briefTitle': 'Low Phosphate Diets in Patients With Early Stages of Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Reduced Phosphate Intake in "Normo-Phosphatemic" Chronic Kidney Disease Patients', 'orgStudyIdInfo': {'id': '2005P000486'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lanthanum Carbonate and Low Phosphorus Diet', 'description': '25% of subjects will receive binders plus a phosphate restricted diet.', 'interventionNames': ['Drug: Lanthanum Carbonate', 'Dietary Supplement: Low Phosphorus Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lanthanum Carbonate and Unrestricted Phosphorus Diet', 'description': '25% binders + unrestricted phosphate diet.', 'interventionNames': ['Drug: Lanthanum Carbonate', 'Dietary Supplement: Unrestricted Phosphorus Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo and Low Phosphorus Diet', 'description': '25% placebo + phosphate restricted diet.', 'interventionNames': ['Dietary Supplement: Low Phosphorus Diet', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo and Unrestricted Phosphorus Diet', 'description': '25% placebo + unrestricted phosphate diet.', 'interventionNames': ['Dietary Supplement: Unrestricted Phosphorus Diet', 'Drug: Placebo']}], 'interventions': [{'name': 'Lanthanum Carbonate', 'type': 'DRUG', 'description': 'Lanthanum carbonate 1000mg 3x/day', 'armGroupLabels': ['Lanthanum Carbonate and Low Phosphorus Diet', 'Lanthanum Carbonate and Unrestricted Phosphorus Diet']}, {'name': 'Low Phosphorus Diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Low phosphorus diet will consist of 800 mg of phosphorus per day.', 'armGroupLabels': ['Lanthanum Carbonate and Low Phosphorus Diet', 'Placebo and Low Phosphorus Diet']}, {'name': 'Unrestricted Phosphorus Diet', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Neutraphos'], 'description': 'Unrestricted diet will contain 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.', 'armGroupLabels': ['Lanthanum Carbonate and Unrestricted Phosphorus Diet', 'Placebo and Unrestricted Phosphorus Diet']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Lanthanum Carbonate placebo given three times a day with meals.', 'armGroupLabels': ['Placebo and Low Phosphorus Diet', 'Placebo and Unrestricted Phosphorus Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Myles Wolf, MD, MMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univesity of Miami Miller School of Medicine'}, {'name': 'Harald Jueppner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shire', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Myles S. Wolf', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}