Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-31 @ 9:55 AM
Study NCT ID:
NCT01820767
Status:
COMPLETED
Last Update Posted:
2018-08-24
First Post:
2013-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients
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'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-22', 'studyFirstSubmitDate': '2013-03-19', 'studyFirstSubmitQcDate': '2013-03-26', 'lastUpdatePostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxidative stress and inflammative parameters in patients wiht CKD stage Vitamin D after 12 weeks of treatment', 'timeFrame': '12 weeks of treatment wiht visits and analysis', 'description': 'Measure parameter: IL-2'}, {'measure': 'Oxidative stress and inflammative parameters', 'timeFrame': '12 weeks of treatment', 'description': 'Measure unit: IL-4'}, {'measure': 'Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'IL-5'}, {'measure': 'Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'IL-6'}, {'measure': 'Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'IL-10'}, {'measure': 'Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'IL-13'}, {'measure': 'Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'TNF-beta'}, {'measure': 'Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'CD3'}, {'measure': 'Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'CD4'}, {'measure': 'Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'CD8'}, {'measure': 'Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'CD19'}, {'measure': 'Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'CD25'}, {'measure': 'Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'CD56'}, {'measure': 'Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'CD69'}, {'measure': 'Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'CD95'}, {'measure': 'Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'COX-2'}, {'measure': 'Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'iNOS'}, {'measure': 'Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'PGE2'}, {'measure': 'Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'FGF-23'}], 'secondaryOutcomes': [{'measure': 'Nutritional Parameters', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'Weight'}, {'measure': 'Erythropoietin requirements variations', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'Fe'}, {'measure': 'Assess potential benefits inflammatory markers', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'PTHi'}, {'measure': 'Nutritional Parameters', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'Height'}, {'measure': 'Nutritional Parameters', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'Body Mass Index (BMI)'}, {'measure': 'Nutritional Parameters', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'Abdominal circumference'}, {'measure': 'Nutritional Parameters', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'Triceps skin fold circumference'}, {'measure': 'Nutritional Parameters', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'Bioimpedance'}, {'measure': 'Anaemia parameters', 'timeFrame': '12 weeks of treatment', 'description': 'Hemogram'}, {'measure': 'Anaemia Parameters', 'timeFrame': '12 weeks of treatment', 'description': 'Biochemistry'}, {'measure': 'Erythropoietin requirement variations', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'Ferritin'}, {'measure': 'Erythropoietin requirement variations', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'Transferrin saturation index'}, {'measure': 'Erythropoietin requirements variations', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'B12'}, {'measure': 'Erythropoietin requirements variations', 'timeFrame': '12 weeks of treatment with visits and analysis', 'description': 'Folic Acid'}, {'measure': 'Assess potential benefits in inflammatory markers', 'timeFrame': '16 weeks, the complete duration of the study', 'description': 'Kt'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease', 'Vd-stadium.', 'Inflammatory patterns', 'Paricalcitol', 'Atorvastatin'], 'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Use of Paricalcitol in stage Vd Chronic Kidney Disease patients, over the effect of inflammatory and oxidative stress parameters.', 'detailedDescription': 'Use of Paricalcitol in stage Vd Chronic Kidney Disease patients using a permanent catheter due to haemodialysis; over the effect of inflammatory and oxidative stress parameters. This study uses paricalcitol (vitamin D) versus atorvastatin versus paricalcitol plus atorvastatin treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vd CKD patients using haemodialysis during 3 or more months.\n* Tunnelized-bearer permanent catheters on haemodialysis at last 6 months previous at the beginning of the study. .\n* Kt stable, over 45 litres on both sexs.\n* Patients in treatment wiht atorvastatin\n* Patients without infectious or inflammatory processes over 8 weeks.\n* Two consecutive PTH \\< than 400 pg/ml; Ca\\<10.2 and P \\<7.0 mg/dl.\n\nExclusion Criteria:\n\n* Patients \\> 18 years.\n* Pregnant women.\n* Patients hospitalized 4 weeks before the beginning of the treatment.\n* Immunosuppressor intake.'}, 'identificationModule': {'nctId': 'NCT01820767', 'acronym': 'SENPARIC', 'briefTitle': 'Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients', 'nctIdAliases': ['NCT02210533'], 'organization': {'class': 'OTHER', 'fullName': 'Hospital El Bierzo'}, 'officialTitle': 'Paricalcitol Action on Parameters of Inflammation and Oxidative Stress in Patients With Chronic Kidney Disease Stage Vd Carriers Tunneled Hemodialysis Catheters', 'orgStudyIdInfo': {'id': 'SENPARIC-2011-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paricalcitol', 'description': 'SUBGROUP 1 (G1): Paricalcitol oral dosis triphosphoinositide mgc/100, 3 days a week.', 'interventionNames': ['Drug: Paricalcitol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paricalcitol, Atorvastatin', 'description': 'SUBGROUP 2 (G2): Paricalcitol (same dosis than G1) + Atorvastatin (1 daily dosis 20 mg)', 'interventionNames': ['Drug: Paricalcitol, atorvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin', 'description': 'SUBGROUP 3 (G3): Atorvastatin (same G2 dosis)', 'interventionNames': ['Drug: Atorvastatin']}], 'interventions': [{'name': 'Paricalcitol', 'type': 'DRUG', 'otherNames': ['Group 1'], 'description': 'Oral Paricalcitol. parathyroid hormone i mcg/100. 3 days per week, the same day as haemodialysis is done, during 12 weeks.', 'armGroupLabels': ['Paricalcitol']}, {'name': 'Paricalcitol, atorvastatin', 'type': 'DRUG', 'otherNames': ['G2'], 'description': 'Oral Paricalcitol. parathyroid hormone i mgc/100. 3 days a week, the same day as haemodialysis, during 12 weeks.\n\nAtorvastatin: 20 mg/day oral (1 take) during 12 weeks.', 'armGroupLabels': ['Paricalcitol, Atorvastatin']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'otherNames': ['G3'], 'description': 'Atorvastatin: 20 mg/day oral (1 take) during 12 weeks', 'armGroupLabels': ['Atorvastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24411,', 'city': 'Ponferrada', 'state': '(León).', 'country': 'Spain', 'facility': 'Hospital El Bierzo. Servicio de Nefrología.', 'geoPoint': {'lat': 42.54664, 'lon': -6.59619}}, {'zip': '24008', 'city': 'León', 'country': 'Spain', 'facility': 'Hospital de León', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}], 'overallOfficials': [{'name': 'Ricardo Mouzo Mirco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital El Bierzo, Fuentesnuevas Ponferrada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ricardo Mouzo Mirco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ricardo Mouzo Mirco', 'investigatorAffiliation': 'Hospital El Bierzo'}}}}