Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT00656032
Status:
COMPLETED
Last Update Posted:
2012-01-11
First Post:
2008-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D, Insulin Resistance and Inflammation in ESRD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C084656', 'term': 'paricalcitol'}, {'id': 'D000069449', 'term': 'Cinacalcet'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-09', 'studyFirstSubmitDate': '2008-04-04', 'studyFirstSubmitQcDate': '2008-04-04', 'lastUpdatePostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'An improvement in insulin sensitivity', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'A change in insulin signaling', 'timeFrame': '8 weeks'}, {'measure': 'A decrease in concentration of plasma pro-inflammatory cytokines', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insulin resistance', 'end stage renal disease'], 'conditions': ['End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'The broad goal of this study is to understand the mechanisms by which Vitamin D receptor activation leads to changes in insulin signaling in advanced uremia. We hypothesize that 1,25-Dihydroxyvitamin D3 deficiency due to advanced chronic kidney disease leads to insulin resistance and that administration of a vitamin D3 analog will restore insulin sensitivity in End Stage Renal Disease patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CKD and receiving hemodialysis for ≥ 3months\n* Kt/V ≥ 1.2\n* ≥ 18 years of age\n* Medically stable\n* AVF or PTFE dialysis access\n* No acute inflammatory disease within 4 weeks prior to the study\n* On stable dose of Paricalcitol for 4 weeks prior to the study\n* iPTH value between 150 - 1500 within the past 3 months\n* Ca \\< 10.5\n* PO4 \\< 10\n\nExclusion Criteria:\n\n* Pregnancy\n* Intolerance to the study medication\n* Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease)\n* Type 1 Diabetes mellitus\n* Uncontrolled Type 2 Diabetes mellitus (HbA1c \\> 10)\n* Hospitalization within 1 month prior to the study\n* Malfunctioning arterial-venous vascular access (recirculation and/or blood flow \\< 250 ml/min)\n* Presence of hemodialysis catheter\n* Patients receiving steroids and/or other immunosuppressive agents (\\> 10 mg prednisone qd)\n* BMI \\< 25 and \\> 45'}, 'identificationModule': {'nctId': 'NCT00656032', 'briefTitle': 'Vitamin D, Insulin Resistance and Inflammation in ESRD', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Vitamin D, Insulin Resistance and Inflammation in ESRD', 'orgStudyIdInfo': {'id': '080074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'SOC medication for treatment of renal osteodystrophy', 'interventionNames': ['Other: paricalcitol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'alternate SOC medication for treatment of renal osteodystrophy', 'interventionNames': ['Other: cinacalcet']}], 'interventions': [{'name': 'paricalcitol', 'type': 'OTHER', 'otherNames': ['zemplar'], 'description': '1 to 20 micrograms administered via IV; every other day, 3 days per week, for 8 weeks', 'armGroupLabels': ['1']}, {'name': 'cinacalcet', 'type': 'OTHER', 'otherNames': ['sensipar'], 'description': '0 to 180 mg administered orally every day for either 8 weeks or 16 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Alp Ikizler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Alp Ikizler', 'investigatorAffiliation': 'Vanderbilt University'}}}}