Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-29 @ 6:42 AM
Study NCT ID:
NCT00792857
Status:
COMPLETED
Last Update Posted:
2014-09-29
First Post:
2008-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C042533', 'term': '1 alpha-hydroxyergocalciferol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-26', 'studyFirstSubmitDate': '2008-11-14', 'studyFirstSubmitQcDate': '2008-11-17', 'lastUpdatePostDateStruct': {'date': '2014-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood levels of CTAP201 and doxercalciferol', 'timeFrame': 'Day 1 and Day 15 of each dose level'}, {'measure': 'Safety of a single dose of CTAP201 Injection', 'timeFrame': 'Throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parathyroid Diseases', 'Renal Insufficiency', 'Kidney Failure, Chronic', 'Hyperparathyroidism, Secondary', 'Vitamin D', 'Hyperparathyroidism', 'Renal Insufficiency, Chronic', 'Kidney Diseases', 'Kidney Failure'], 'conditions': ['Chronic Kidney Disease', 'Secondary Hyperparathyroidism', 'Chronic Renal Insufficiency', 'Chronic Renal Failure']}, 'descriptionModule': {'briefSummary': 'This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different dose strengths. This study will also investigate the levels of CTAP201 in the body over time and determine the safety of CTAP201.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index between 18 and 40\n* On maintenance hemodialysis three times per week\n* Visit 1: Serum iPTH value greater than or equal to 200 pg/mL and lower than or equal to 1000 pg/mL\n* Visit 1: Serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL\n* Visit 1: Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL\n* Serum 25-hydroxyvitamin D level greater than or equal to 15 ng/mL\n* Visit 2: Serum iPTH value greater than 300 pg/mL\n* Visit 2: Serum Ca x P product less than 56 \\[mg/dl\\]2\n* Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and length of study\n\nExclusion Criteria:\n\n* Taking cytochrome P450 3A inhibitors and/or inducers\n* Abnormal liver functions'}, 'identificationModule': {'nctId': 'NCT00792857', 'briefTitle': 'Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'OPKO Health, Inc.'}, 'officialTitle': 'Single-Dose, Two-Period, Open Label, Dose Determination, Randomized, Cross-Over Study of CTAP201 Injection and Doxercalciferol (Hectorol) Injection in Subjects With Stage 5 CKD and SHPT on Hemodialysis', 'orgStudyIdInfo': {'id': 'CTAP201-CL-1007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CTAP201 Injection at dose a', 'description': 'CTAP201 at dose a', 'interventionNames': ['Drug: CTAP201 Injection']}, {'type': 'EXPERIMENTAL', 'label': 'CTAP201 Injection', 'description': 'CTAP201 at dose b or dose c', 'interventionNames': ['Drug: CTAP201 Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Doxercalciferol at dose a', 'description': 'Active at dose a', 'interventionNames': ['Drug: Doxercalciferol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Doxercalciferol', 'description': 'Active at dose b or dose c', 'interventionNames': ['Drug: Doxercalciferol']}], 'interventions': [{'name': 'CTAP201 Injection', 'type': 'DRUG', 'description': 'Comparison of different dose strengths of CTAP201 after single dose.', 'armGroupLabels': ['CTAP201 Injection', 'CTAP201 Injection at dose a']}, {'name': 'Doxercalciferol', 'type': 'DRUG', 'otherNames': ['Hectorol'], 'description': 'Comparison of different dose strengths of doxercalciferol after single dose.', 'armGroupLabels': ['Doxercalciferol', 'Doxercalciferol at dose a']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pivotal Reseach Centers', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '01107', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Western New England Renal and Transplant Associates', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '45206', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '18103-6379', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Northeast Clinical Research', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77099', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Southwest Houston Research Ltd.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Joel Melnick, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'OPKO Renal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OPKO IP Holdings II, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}