Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-27 @ 10:37 PM
Study NCT ID:
NCT00888069
Status:
COMPLETED
Last Update Posted:
2014-09-30
First Post:
2009-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-29', 'studyFirstSubmitDate': '2009-04-23', 'studyFirstSubmitQcDate': '2009-04-23', 'lastUpdatePostDateStruct': {'date': '2014-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT', 'timeFrame': 'from 3 to 0 hours prior to dosing until 42 days post dosing'}], 'secondaryOutcomes': [{'measure': 'To assess the safety and tolerability of CTAP101 capsules and injection', 'timeFrame': 'From signing of ICF (Day -35) through study completion (Day 42 post dosing)'}, {'measure': 'To assess the pharmacodynamics of single dose CTAP101 in Stage 3 and Stage 4 CKD subjects with vitamin D insufficiency and SHPT.', 'timeFrame': 'From signing of ICF (Day -35) through study completion (Day 42 post dosing)'}]}, '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 investigate how the levels of a single dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with Stage 3 or 4 chronic kidney disease (CKD) with vitamin D insufficiency and secondary hyperparathyroidism (SHPT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index between great than or equal to 18 and less than or equal to 40 kg/m2\n* Plasma iPTH value for Stage 3 CKD greater than or equal to 70 pg/mL and lower than or equal to 1000 pg/mL\n* Plasma iPTH value for Stage 4 CKD greater than or equal to 110 pg/mL and lower than or equal to 1000 pg/mL\n* Adjusted serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL\n* 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 15 ng/mL and lower than 30 ng/mL\n* Hemoglobin level greater than or equal to 10 g/dL\n\nExclusion Criteria:\n\n* Has nephrotic range proteinuria\n* Has liver disease or significant hepatic dysfunction\n* Is taking Cytochrome P450 3A4 inhibitors or inducers\n* Has adult history of kidney stones and dysphagia\n* Has known history of alcohol/controlled substance abuse or are positive for drug of abuse screen\n* Currently on dialysis\n* Current serious illness such as cancer, HIV, cardiovascular event or hepatitis'}, 'identificationModule': {'nctId': 'NCT00888069', 'briefTitle': 'Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'OPKO Health, Inc.'}, 'officialTitle': 'A Randomized, Open-Label, Single-Dose Pilot Study of Oral and i.v. CTAP101 Evaluating PK and Safety in Stage 3 and 4 CKD Subjects With Vitamin D Insufficiency and SHPT', 'orgStudyIdInfo': {'id': 'CTAP101-CL-2004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Dose CTAP101 Capsules', 'description': 'CTAP101 Capsules, 450 mcg dose', 'interventionNames': ['Drug: CTAP101 Capsules']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose CTAP101 Capsules', 'description': 'CTAP101 Capsules, 900 mcg dose', 'interventionNames': ['Drug: CTAP101 Capsules']}, {'type': 'EXPERIMENTAL', 'label': 'CTAP101 Injection', 'description': 'IV injection, 448 mcg dose', 'interventionNames': ['Drug: CTAP101 Injection']}], 'interventions': [{'name': 'CTAP101 Capsules', 'type': 'DRUG', 'description': 'Single dose oral administration', 'armGroupLabels': ['High Dose CTAP101 Capsules', 'Low Dose CTAP101 Capsules']}, {'name': 'CTAP101 Injection', 'type': 'DRUG', 'description': 'single IV injection', 'armGroupLabels': ['CTAP101 Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pivotal Research Centers', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '60805', 'city': 'Evergreen Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research by Design', 'geoPoint': {'lat': 41.72059, 'lon': -87.70172}}, {'zip': '01107', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Western New England Renal & Transplant Associates', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '55430', 'city': 'Brooklyn Center', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Twin Cities Clinical Research', 'geoPoint': {'lat': 45.07608, 'lon': -93.33273}}, {'zip': '45206', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'DCI', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44109-1998', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Northeast Clinical Research', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Southeast Renal Research Institute', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', '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}}, {'zip': '53018', 'city': 'Delafield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Purity Dialysis Centers / Nephrology Associates', 'geoPoint': {'lat': 43.06084, 'lon': -88.40371}}, {'zip': '54601', 'city': 'La Crosse', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Gunderson Clinic Ltd.', 'geoPoint': {'lat': 43.80136, 'lon': -91.23958}}], 'overallOfficials': [{'name': 'Joel Melnick, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'OPKO Renal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OPKO IP Holdings II, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}