Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-31 @ 11:53 AM
Study NCT ID:
NCT00048451
Status:
COMPLETED
Last Update Posted:
2006-08-02
First Post:
2002-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C084656', 'term': 'paricalcitol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'statusVerifiedDate': '2006-07', 'lastUpdateSubmitDate': '2006-07-31', 'studyFirstSubmitDate': '2002-10-31', 'studyFirstSubmitQcDate': '2002-11-01', 'lastUpdatePostDateStruct': {'date': '2006-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-11-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline iPTH levels.'}]}, 'conditionsModule': {'conditions': ['Renal Insufficiency, Chronic']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine whether paricalcitol is safe and effective compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Under care of physician at least 2 months (for CKD)\n* Not on active Vitamin D therapy for at least 4 weeks prior\n* If female:\n\n * Not of childbearing potential, OR\n * Practicing birth control\n * Not breastfeeding\n* If taking phosphate binders, on a stable regimen at least 4 weeks prior\n* For entry into Pretreatment Phase:\n\n * iPTH at least 120 pg/mL\n * GFR of 15-60 mL/min and no dialysis expected for at least 6 months\n* For entry into Treatment Phase:\n\n * Average of 2 consecutive iPTH values of at least 150 pg/mL, taken at least 1 day apart (all values not less than 120 pg/mL\n * 2 consecutive corrected serum calcium levels between 8.0-10.0 mg/dL\n * 2 consecutive serum phosphorus levels of not more than 5.2 mg/mL\n\nExclusion Criteria:\n\n* History of allergic reaction or sensitivity to similar drugs\n* Acute Renal Failure within 12 weeks of study\n* Chronic gastrointestinal disease\n* Spot urine result demonstrating a urine-calcium-to-urine creatinine ratio of greater than 0.2, or a history of renal stones\n* Taken aluminum-containing phosphate binders within last 12 weeks, or requires such medication for more than 3 weeks during study\n* Current malignancy, or clinically significant liver disease\n* Active granulomatous disease (TB, sarcoidosis, etc.)\n* History of drug or alcohol abuse within 6 mos. prior\n* Evidence of poor compliance with diet or medication\n* Received any investigational drug or participated in any device trial within 30 days prior\n* Taking maintenance calcitonin, bisphosphonates, or drugs that may affect calcium or bone metabolism (other than females on stable estrogen and/or progestin therapy)\n* On glucocorticoids for a period of more than 14 days within the last 6 months\n* HIV positive'}, 'identificationModule': {'nctId': 'NCT00048451', 'briefTitle': 'Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)', 'orgStudyIdInfo': {'id': '2001-020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'paricalcitol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tucson Therapeutic Research Institute, Inc.', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'California Institute of Renal Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91356', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'Nephrology Educational Services and Research, Inc.', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Phoenix Internal Medicine Associates', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Kidney Group', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'ICSL Clinical Studies', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Genesis Clinical Research Corporation', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Evanston Northwestern Healthcare', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Medisphere Medical Research Center', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic Chronic Dialysis', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Biolab Research, LLC', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Rogosin Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45206', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dialysis Clinic, Inc.', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Kidney Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '79430', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University Health Science Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Wojskowy Instytut Medyczny', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Laura Williams, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}}}}