Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-27 @ 9:23 AM
Study NCT ID:
NCT04987450
Status:
UNKNOWN
Last Update Posted:
2021-08-03
First Post:
2021-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Glucocorticoids on Inflammation and Bone Metabolism in Patients With Glomerular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537525', 'term': 'Sclerosteosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011244', 'term': 'Pregnadienediols'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-02', 'studyFirstSubmitDate': '2021-07-22', 'studyFirstSubmitQcDate': '2021-08-02', 'lastUpdatePostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change of plasma SIRT-1 level after glucocorticoids administration', 'timeFrame': '30 days'}, {'measure': 'the change of plasma sclerostin level after glucocorticoids administration', 'timeFrame': '30 days'}, {'measure': 'the change of plasma FGF-23 level after glucocorticoids administration', 'timeFrame': '30 days'}, {'measure': 'the change of plasma IL-6 level after glucocorticoids administration', 'timeFrame': '30 days'}, {'measure': 'the change of plasma total calcium level after glucocorticoids administration', 'timeFrame': '30 days'}, {'measure': 'the change of plasma phosphate level after glucocorticoids administration', 'timeFrame': '30 days'}, {'measure': 'the change of plasma PTH level after glucocorticoids administration', 'timeFrame': '30 days'}, {'measure': 'the change of urine albumin/creatinine ratio after glucocorticoids administration', 'timeFrame': '30 days'}, {'measure': 'the change of urine total protein/creatinine ratio after glucocorticoids administration', 'timeFrame': '30 days'}, {'measure': 'the change of urine phosphate/creatinine ratio after glucocorticoids administration', 'timeFrame': '30 days'}, {'measure': 'the change of urine calcium/creatinine ratio after glucocorticoids administration', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glucocorticoids', 'primary glomerular disease', 'sirtuin-1', 'sclerostin'], 'conditions': ['Glomerular Disease']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the influence of high doses of intravenous corticosteroids on plasma inflammation and bone markers in patients with primary glomerular disease. The study would include 40 patients with chronic kidney disease. The main inclusion criterion is clinical and histopathological diagnosis of primary glomerular disease and urine protein excretion \\>2.0 g/24h. The exclusion criteria include secondary glomerular disease, acute kidney injury, acute or chronic inflammation, history of non-compliance.', 'detailedDescription': 'Glucocorticoids are one of the most widely used classes of drugs to treat inflammatory and autoimmune diseases. They increase formation of osteoclasts and enhance bone resorption thereby increasing risk of bone fractures and osteoporosis.\n\nSirtuin-1(SIRT-1) belongs to family of proteins involved in protection against inflammation and oxidative stress. A role of SIRT-1 in regulation of bone metabolism during high-dose steroid therapy is unknown.\n\nThe study protocol was approved by the local Bioethics Committee and the study is conducted according to the Declaration of Helsinki. Adult patients with the previous diagnosed primary glomerular disease based on both clinical and renal biopsy findings are included.\n\nPlasma concentration of SIRT-1, interleukin-6 (IL-6), fibroblast growth factor 23 (FGF-23), sclerostin, calcium, phosphate, parathormone (PTH) and urine excretion of total protein, albumin, creatinine, calcium and phosphate are measured at baseline. Then the patients receive three intravenous pulses of methylprednisolone of 500 mg followed by oral prednisone 0.8-1.0 mg/kg/24h. The same measurements are repeated 4, 7 and 30 days after starting the steroid treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients with primary glomerular disease who are diagnosed and hospitalized in Nephrology Department in Łódź.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* previous diagnosed primary glomerular disease based on both clinical and renal biopsy findings\n* an estimated glomerular filtration rate ≥15 ml/min/1.73m2\n* proteinuria ≥2.0 g/24h\n\nExclusion Criteria:\n\n* secondary glomerular disease\n* acute kidney injury\n* acute or chronic inflammation\n* malignancy\n* uncontrolled hypertension with systolic blood pressure higher than 160 mmHg\n* symptomatic hypotension\n* advanced heart failure\n* history of non-compliance, dementia or depression'}, 'identificationModule': {'nctId': 'NCT04987450', 'briefTitle': 'Effect of Glucocorticoids on Inflammation and Bone Metabolism in Patients With Glomerular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lodz'}, 'officialTitle': 'Effect of High-dose Glucocorticoids on Markers of Inflammation and Bone Metabolism in Patients With Primary Glomerular Disease', 'orgStudyIdInfo': {'id': 'RNN/267/17/KE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study population', 'description': 'Plasma levels of SIRT-1, IL-6, FGF-23, sclerostin, calcium, phosphate, PTH and urine excretion of total protein, albumin, creatinine, calcium and phosphate are measured at baseline. Then the patients receive three intravenous daily pulses of methylprednisolone of 500 mg followed by oral prednisone 0.8-1.0 mg/kg/24h. The same measurements are repeated 4, 7 and 30 days after starting the steroid treatment.', 'interventionNames': ['Drug: Methylprednisolone, prednisone']}], 'interventions': [{'name': 'Methylprednisolone, prednisone', 'type': 'DRUG', 'description': 'The patients receive intravenous pulses of methylprednisolone 20-30 mg/kg/day for three consecutive days followed by oral prednisone 0.8-1.0 mg/kg/day.', 'armGroupLabels': ['Study population']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lodz', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Ireneusz Staroń, Study Chair', 'role': 'CONTACT', 'email': 'ireneusz.staron@umed.lodz.pl'}], 'facility': 'Medical University of Lodz, Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}], 'centralContacts': [{'name': 'Michał Nowicki, Prof. MD.', 'role': 'CONTACT', 'email': 'nefro@wp.pl', 'phone': '+ 48 42 2014400'}, {'name': 'Katarzyna Pęczek, Dr', 'role': 'CONTACT', 'email': 'katarzyna.peczek90@gmail.com'}], 'overallOfficials': [{'name': 'Michał Nowicki, Prof. MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, Hypertension and Kidney Transplantation Medical University of Lodz, Poland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lodz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Michal Nowicki', 'investigatorAffiliation': 'Medical University of Lodz'}}}}