Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-02-05 @ 7:39 PM
Study NCT ID:
NCT00268957
Status:
COMPLETED
Last Update Posted:
2014-03-19
First Post:
2005-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}, {'id': 'D054559', 'term': 'Hyperphosphatemia'}], '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'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069603', 'term': 'Sevelamer'}], 'ancestors': [{'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-17', 'studyFirstSubmitDate': '2005-12-22', 'studyFirstSubmitQcDate': '2005-12-22', 'lastUpdatePostDateStruct': {'date': '2014-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demonstrate the efficacy of sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets dosed TID with meals on the control of serum phosphorus', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Evaluate the safety and tolerability of sevelamer carbonate powder dosed QD with the largest meal compared to sevelamer hydrochloride tablets dosed TID with meals', 'timeFrame': 'Up to 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Compare sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets TID with meals on serum calcium-phosphorus product and serum lipid profile', 'timeFrame': 'Up to 24 weeks'}]}, 'conditionsModule': {'keywords': ['Chronic', 'Hemodialysis', 'Kidney', 'Hyperphosphatemia', 'Chronic kidney disease', 'Chronic Renal Insufficiency'], 'conditions': ['Kidney Diseases', 'Chronic Renal Insufficiency', 'End-Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'Approximately 207 patients with chronic kidney disease (CKD) on hemodialysis will be entered into this study at approximately 26 centers in the United States. This study aims to evaluate the safety and efficacy of sevelamer carbonate powder dosed once-a-day (QD) with the largest meal compared to sevelamer hydrochloride tablets dosed three-times-per-day (TID) with meals. The total length of participation is approximately 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* On three times per week hemodialysis for three months or longer\n* Currently on a phosphate binder(s)\n* Considered compliant with phosphate binders and hemodialysis therapy\n* Willing to avoid any intentional changes in diet such as fasting or dieting\n* Have the following documented local laboratory measurements:a.Two most recent consecutive serum phosphorus measurements that are ≥ 3.0 and ≤ 6.5 (6.5) mg/dL within 60 days of screening; b.A most recent intact parathyroid hormone (iPTH) measurement ≤ 800 pg/mL within 90 days of screening\n* Have the following central laboratory measurements: a.A serum phosphorus measurement \\> 5.5 mg/dL at randomization (Week 0);b.A serum iPTH measurement ≤ 800 pg/mL at screening\n* Have not participated in any other investigational drug studies within 30 days prior to enrollment\n* Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel\n* Willing and able to take sevelamer alone as a phosphate binder for the duration of the study\n* Willing and able to maintain screening doses of lipid medication for the duration of the study, except for safety reasons\n* Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement\n* If female and of childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout the study, which includes barrier methods, hormones, or intrauterine devices (IUDs)\n* Life expectancy of 12 months or greater\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Active bowel obstruction, dysphagia, swallowing disorder, or severe gastrointestinal (GI) motility disorders\n* Active ethanol or drug abuse, excluding tobacco use\n* In the opinion of the Investigator, subject has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition\n* Use of anti-arrhythmic or anti-seizure medications for the use of arrhythmia or seizure disorders\n* Known hypersensitivity to sevelamer or any constituents of the study drug\n* Pregnant or breast-feeding\n* Evidence of active malignancy except for basal cell carcinoma of the skin\n* Unable to comply with the requirements of the study\n* Any other condition which, in the opinion of the Investigator, will prohibit the subject's inclusion in the study"}, 'identificationModule': {'nctId': 'NCT00268957', 'briefTitle': 'Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Parallel, Open-Label Study to Compare Once Per Day Sevelamer Carbonate Powder Dosing With Three Times Per Day Sevelamer Hydrochloride Tablet Dosing in Chronic Kidney Disease Patients on Hemodialysis', 'orgStudyIdInfo': {'id': 'GD3-199-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'sevelamer carbonate powder', 'interventionNames': ['Drug: Sevelamer carbonate (Renvela®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Sevelamer hydrochloride', 'interventionNames': ['Drug: Sevelamer hydrochloride (Renagel®)']}], 'interventions': [{'name': 'Sevelamer carbonate (Renvela®)', 'type': 'DRUG', 'description': 'sevelamer carbonate powder dosed once per day with largest meal', 'armGroupLabels': ['1']}, {'name': 'Sevelamer hydrochloride (Renagel®)', 'type': 'DRUG', 'description': 'Sevelamer hydrochloride tablets dosed three times a day with meals', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35213', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Research Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35901', 'city': 'Gadsden', 'state': 'Alabama', 'country': 'United States', 'facility': 'Gadsden Dialysis', 'geoPoint': {'lat': 34.01434, 'lon': -86.00639}}, {'zip': '91345', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'Holy Cross Renal Care', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '91356', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'Nephrology Educational Services and Research', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '34429', 'city': 'Crystal River', 'state': 'Florida', 'country': 'United States', 'facility': 'Crystal Rivers Dialysis Center', 'geoPoint': {'lat': 28.90248, 'lon': -82.5926}}, {'zip': '34667', 'city': 'Hudson', 'state': 'Florida', 'country': 'United States', 'facility': 'Outcomes Research International, Inc.', 'geoPoint': {'lat': 28.36445, 'lon': -82.69343}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Central Dialysis Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Nephrology Referral Center', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '30066', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'FMC Marietta', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60422', 'city': 'Flossmoor', 'state': 'Illinois', 'country': 'United States', 'facility': 'Horizon Healthcare Associates', 'geoPoint': {'lat': 41.54281, 'lon': -87.68477}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic Foundation, Nephrology Research', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '39601', 'city': 'Brookhaven', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Southwest Mississippi Nephrology, PLLC', 'geoPoint': {'lat': 31.57906, 'lon': -90.44065}}, {'zip': '39705', 'city': 'Columbus', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Nephrology Associates, P.C.', 'geoPoint': {'lat': 33.49567, 'lon': -88.42726}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Nephrology & Hypertension Associates, LTD', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07724', 'city': 'Eatontown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hypertension and Nephrology Associates', 'geoPoint': {'lat': 40.29622, 'lon': -74.05097}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Winthrop University Dialysis Center', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Davita', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Kidney and Hypertension Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Renal Care Group', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '17044', 'city': 'Lewistown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lewiston Dialysis Center', 'geoPoint': {'lat': 40.59924, 'lon': -77.57138}}, {'zip': '38024', 'city': 'Dyersburg', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Medical Nephrology Associates', 'geoPoint': {'lat': 36.03452, 'lon': -89.38563}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Nephrology Associates, P.C.', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Renal Research Inc. at the Kidney Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22902', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Gambro Healthcare - Charlottesville', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Clinical Research of Tidewater', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University, Division of Nephrology', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genzyme, a Sanofi Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genzyme, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Monitor', 'oldOrganization': 'Genzyme Corporation'}}}}