Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-01 @ 1:43 AM
Study NCT ID:
NCT01768351
Status:
COMPLETED
Last Update Posted:
2014-07-30
First Post:
2013-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paricalcitol Effect on Anemia in CKD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D006961', 'term': 'Hyperparathyroidism'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C084656', 'term': 'paricalcitol'}, {'id': 'D002117', 'term': 'Calcitriol'}], 'ancestors': [{'id': 'D004100', 'term': 'Dihydroxycholecalciferols'}, {'id': 'D006887', 'term': 'Hydroxycholecalciferols'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-29', 'studyFirstSubmitDate': '2013-01-13', 'studyFirstSubmitQcDate': '2013-01-13', 'lastUpdatePostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modification in hemoglobin levels', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Modifications in urinary protein excretion', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anemia', 'chronic kidney disease', 'vitamin D', 'paricalcitol', 'hyperparathyroidism'], 'conditions': ['Anemia', 'Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '25781618', 'type': 'DERIVED', 'citation': 'Riccio E, Sabbatini M, Bruzzese D, Capuano I, Migliaccio S, Andreucci M, Pisani A. Effect of paricalcitol vs calcitriol on hemoglobin levels in chronic kidney disease patients: a randomized trial. PLoS One. 2015 Mar 17;10(3):e0118174. doi: 10.1371/journal.pone.0118174. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'Current activated Vitamin D therapies are approved for treating secondary hyperparathyroidism in chronic kidney disease (CKD), and a large body of experimental data in animals confirms the effects of Vitamin D that extend beyond mineral metabolism. Several studies show that the benefits are greater with the newer vitamin D analog paricalcitol when compared with calcitriol. A large gap exists in our knowledge between epidemiological studies in human that demonstrate improved outcomes with vitamin D use and observations in preclinical studies demonstrating the pleiotropic effects of Vitamin D. To explore the provenance of epidemiological outcomes in CKD, we conducted a pilot randomized trial to determine whether the use of paricalcitol, compared to calcitriol, leads to improvement in anemia, a marker associated with worse outcomes in chronic kidney disease, and whether this effect not only reflects the hyperparathyroidism correction, but is also dependent on the direct effects of paricalcitol on erythroid progenitor cells.', 'detailedDescription': 'To better understand the direct effects of paricalcitol on anemia in patients with chronic kidney disease (stage 3-5), we conducted a pilot trial in 60 patients who were randomly allocated equally to 2 groups to receive or not paricalcitol orally for 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* age \\> 18\n* written informed consent\n* CKD stage 3-5 (eGFR \\<60 ml/min/1,73 m2)\n* PTH 30-300 pg/ml\n* Hb \\<10 g/dl \\>3 consecutive months\n* Ferritin \\> 100 ng/ml\n* transferrin saturation (TSAT) 20-40%\n* mean corpuscular volume (MCV) 85-95%\n* for patients treated with Ace-inhibitors or angiotensin receptor blockers, dose stable \\>3 months\n* for patients treated with erythropoiesis-stimulating agents (ESA), dose stable \\>3 months\n\nExclusion criteria:\n\n* anemia due to non renal cause\n* presence of malignancies, inflammatory or infectious disease \\>3 months\n* pregnancy\n* bleeding \\>6 months\n* C-reactive protein (CRP) \\>1 mg/dl\n* poorly controlled hypertension (PAS \\> 170 mmHG and PAD \\>100 mmHg)\n* severe malnutrition\n* hypercalcemia (\\>10,5 mg/dl)\n* hyperphosphatemia (\\>5,5 mg/dl)\n* surgical interventions \\>3 months\n* acute myocardial infarction, unstable angina, stroke or transitory ischemic attack, deep venous or pulmonary thromboembolism, congestive heart failure \\>3 months'}, 'identificationModule': {'nctId': 'NCT01768351', 'briefTitle': 'Paricalcitol Effect on Anemia in CKD', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Direct Effect of Paricalcitol on Anemia in Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'PCX1234'}, 'secondaryIdInfos': [{'id': 'paranemia', 'type': 'OTHER', 'domain': 'Federico II University of Naples'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Patients receiving treatment for secondary hyperparathyroidism with calcitriol. The calcitriol dosage schedule provided for an initial dose of 0.5 mch every other day and titration was performed on the basis of the serum levels of intact PTH (iPTH) (target 150-300 pg/mL), Ca, P and Ca x P product as suggested by the US National Kidney Foundation Dialysis outcomes Quality Initiative (NKF-DOQI) and Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.', 'interventionNames': ['Drug: Calcitriol']}, {'type': 'EXPERIMENTAL', 'label': 'Paricalcitol', 'description': 'Patients treated by Paricalcitol for hyperparathyroidism. The paricalcitol initial dose was 1 mcg/die, and titration was performed on the basis of the serum levels of iPTH, Ca, P and Ca x P product as suggested by the NKF-DOQI and KDIGO guidelines.', 'interventionNames': ['Drug: Paricalcitol']}], 'interventions': [{'name': 'Paricalcitol', 'type': 'DRUG', 'otherNames': ['Zemplar'], 'description': 'Zemplar cp 1 mcg/day per os', 'armGroupLabels': ['Paricalcitol']}, {'name': 'Calcitriol', 'type': 'DRUG', 'otherNames': ['Rocaltrol'], 'description': 'Rocaltrol cp 0,5 mcg every other day per os', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80129', 'city': 'Naples', 'country': 'Italy', 'facility': 'Federico II University', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Eleonora Riccio, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Eleonora Riccio', 'investigatorAffiliation': 'Federico II University'}}}}