Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-29 @ 1:05 AM
Study NCT ID:
NCT00123461
Status:
COMPLETED
Last Update Posted:
2015-05-05
First Post:
2005-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System 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'}, {'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': 'C042533', 'term': '1 alpha-hydroxyergocalciferol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-04', 'studyFirstSubmitDate': '2005-07-21', 'studyFirstSubmitQcDate': '2005-07-21', 'lastUpdatePostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Laboratory measurement of intact parathyroid hormone (iPTH)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Laboratory measurement of serum bone markers', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Secondary Hyperparathyroidism', 'Renal Failure', 'Chronic Renal Insufficiency']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.hectorol.com/docs/Hectorol%20Capsule%20PI%20Text_2006-01.pdf', 'label': 'US FDA Approved Full Prescribing Information for Hectorol® Capsules'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the safety and effectiveness of Hectorol® (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney disease (CKD) with secondary hyperparathyroidism who have vitamin D levels in the normal range. Previous studies with doxercalciferol were conducted in patients who had low levels of vitamin D.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Plasma iPTH value above 110 pg/mL for CKD Stage 3 subjects or above 150 pg/mL for CKD Stage 4\n* Serum 25-hydroxyvitamin D level greater than or equal to 30 ng/mL\n* CKD Stage 3 evidenced by a glomerular filtration rate (GFR) from the abbreviated MDRD equation between 30-59 mL/min or CKD Stage 4 evidenced by a glomerular filtration rate (GFR) from the abbreviated MDRD equation between 15-29 mL/min\n\nExclusion Criteria:\n\n* Serum cCa \\> 9.5 mg/dL\n* Serum P \\> 4.6 mg/dL\n* Abnormal liver functions\n* Anticipated requirement for maintenance hemodialysis\n* Use of active vitamin D sterol therapy'}, 'identificationModule': {'nctId': 'NCT00123461', 'briefTitle': 'Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Assess the Efficacy and Safety of Doxercalciferol Capsules in Vitamin D-replete Subjects With Chronic Kidney Disease (CKD) Stages 3 or 4 With Secondary Hyperparathyroidism (SHPT).', 'orgStudyIdInfo': {'id': 'BCI-CH-151'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hectorol (doxercalciferol capsules), 0.5mcg', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'AKDHC Medical Research Services', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Alhambra', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Diabetes Reseach Center', 'geoPoint': {'lat': 34.09529, 'lon': -118.12701}}, {'zip': '92501', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Apex Research of Riverside', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Discovery Medical Research Group', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '33410', 'city': 'Palm Beach Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Nephrology Associates', 'geoPoint': {'lat': 26.82339, 'lon': -80.13865}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Kidney Associates, Inc.', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '48341', 'city': 'Pontiac', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Kidney Consultants, P.C.', 'geoPoint': {'lat': 42.63892, 'lon': -83.29105}}, {'zip': '55430', 'city': 'Brooklyn Center', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Twin Cities Clinical Research', 'geoPoint': {'lat': 45.07608, 'lon': -93.33273}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Nephrology Associates, PA', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '58201', 'city': 'Grand Forks', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Altru Health System Research Center', 'geoPoint': {'lat': 47.92526, 'lon': -97.03285}}, {'zip': '17044', 'city': 'Lewiston', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'DaVita Lewiston Dialysis Center'}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '00725', 'city': 'Caguas', 'country': 'Puerto Rico', 'facility': 'Instituto Renal del Este', 'geoPoint': {'lat': 18.23412, 'lon': -66.0485}}, {'zip': '00918', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Jose Cangiano, MD', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], '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'}}}}