Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-25 @ 2:27 PM
Study NCT ID:
NCT00294866
Status:
COMPLETED
Last Update Posted:
2010-04-08
First Post:
2006-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-09-24', 'releaseDate': '2015-08-26'}], 'estimatedResultsFirstSubmitDate': '2015-08-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'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': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-07', 'studyFirstSubmitDate': '2006-02-17', 'studyFirstSubmitQcDate': '2006-02-17', 'lastUpdatePostDateStruct': {'date': '2010-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome is a 20% change in IL-6 as a function of paricalcitol therapy.', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome is a significant change in markers of inflammation to include:', 'timeFrame': '4 weeks'}, {'measure': 'CRP,TNFα, IL-1β, IL-8, IL-10, IL-12p70, PTH, Ca/P', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['End Stage Renal Disease', 'Inflammation'], 'conditions': ['Kidney Failure']}, 'descriptionModule': {'briefSummary': 'Studies have shown that patients with ESRD on hemodialysis have high levels of inflammatory markers which may contribute to the high rates of cardiovascular disease and mortality seen in these patients. Vitamin D use in dialysis patients has been shown to have a survival benefit, with paricalcitol at advantage over calcitriol. Since there is some evidence for involvement of the vitamin D receptor in inflammation, this study is designed to look for an effect of paricalcitol on markers of inflammation in hemodialysis patients.', 'detailedDescription': 'Patients with ESRD have a high incidence of acute phase inflammation. Studies have shown that C-reactive Protein (CRP) and interleukin-6 (IL-6) are excellent biomarkers for inflammation, and high levels are predictive of cardiovascular morbidity and mortality in this population. Both uremia and the dialysis process itself contribute to this inflammatory state. It is our hypothesis that paricalcitol therapy decreases the biomarkers of inflammation which may have implications for future studies of morbidity and mortality in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. CKD and receiving hemodialysis for greater than or equal to 3 months\n2. Age greater than or equal to 18 years\n3. Medically stable\n4. AVF or PTFE dialysis access\n5. No acute inflammatory disease within 4 weeks prior to study\n6. On an average dose of 3 - 7 mcg of paricalcitol three times per week for 4 weeks prior to the study\n7. Two consecutive iPTH of 150-400 (biPTH 75 - 200) =/- 30% one week apart\n8. Ca \\<10.2 mg/dL; PO4 \\<7.0\n9. Kt/V greater than or equal to 1.2\n10. On no other interventional drugs/devices in the past 30 days\n\nExclusion Criteria:\n\n1. Currently receiving dialysis using a venous catheter access\n2. Currently receiving high dose immunosuppressive therapy (greater than or equal to 10 mg prednisone)\n3. Pregnancy\n4. Hospitalization within the last 4 weeks. -'}, 'identificationModule': {'nctId': 'NCT00294866', 'briefTitle': 'Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Medical Care North America'}, 'officialTitle': 'An Open Label, Multi-Center Study of the Effect of Paricalcitol on Markers of Inflammation in Patients With Stage 5 Chronic Kidney Disease on Hemodialysis.', 'orgStudyIdInfo': {'id': '2005002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Receive Paricalcitol', 'interventionNames': ['Drug: Paricalcitol']}, {'type': 'NO_INTERVENTION', 'label': 'B', 'description': 'Paricalcitol on hold', 'interventionNames': ['Drug: Paricalcitol']}], 'interventions': [{'name': 'Paricalcitol', 'type': 'DRUG', 'description': 'Patients randomized to either receive Paricalcitol or have it held. After 4 weeks they are switched to the opposite intervention.', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60805', 'city': 'Evergreen Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southwest Nephrology', 'geoPoint': {'lat': 41.72059, 'lon': -87.70172}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Nephrology Center', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '07052', 'city': 'West Orange', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Nephrology Associates P.A.', 'geoPoint': {'lat': 40.79871, 'lon': -74.23904}}, {'zip': '19144', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Delaware Valley Nephrology', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Nephrology Associates, PC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75701', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Tyler Nephrology Associates', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}], 'overallOfficials': [{'name': 'Mark R Kaplan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fresenius Medical Care North America'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Medical Care North America', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Mark Kaplan, M.D., Vice President of Clinical Research', 'oldOrganization': 'Fresenius Medical Care North America'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-08-26', 'type': 'RELEASE'}, {'date': '2015-09-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Fresenius Medical Care North America'}}}}