Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-24 @ 8:49 AM
Study NCT ID:
NCT02859220
Status:
COMPLETED
Last Update Posted:
2016-08-09
First Post:
2011-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Influence of Dosages of 1-84 and 7-84 Fragments of Parathyroid Hormone Compared to Conventional Dosage on the Balance of Calcium and Phosphate in Hemodialysis (PTH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-03', 'studyFirstSubmitDate': '2011-06-29', 'studyFirstSubmitQcDate': '2016-08-03', 'lastUpdatePostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improving the therapeutic management of calcium and phosphate abnormalities by conventional PTH', 'timeFrame': 'one year', 'description': 'Show that patients receiving a dose of complete PTH 1-84 (CAP) and the ratio PTH 1-84/7-84 more easily reach the objectives international guidelines on the three following parameters calcium and phosphate: phosphorus, corrected calcium and phosphorus product.\n\nFor each patient, a score will be awarded based on the number of criteria (including calcium, phosphorus and calcium phosphate product) in the target international guidelines:0-1-2 or 3.'}]}, 'conditionsModule': {'keywords': ['hemodialysis', 'PTH'], 'conditions': ['Hemodialysis Patients']}, 'descriptionModule': {'briefSummary': 'This study included 80 patients with end stage renal disease requiring dialysis treatment to evaluate two techniques for the determination of parathyroid hormone (PTH)\n\nObjective: To evaluate whether the monitoring of hemodialysis patients by measurement of PTH 1-84 Complete (CAP =cyclase activating PTH) and the ratio (1-84 PTH (CAP)/7-84 PTH (CIP = cyclase inactivating PTH) with kit "Duo PTH Immunoradiometric Scantibodies" allows an improvement in the therapeutic management of abnormal calcium and phosphate, with a better match to the targets of current international recommendations, followed by the conventional intact PTH assay.\n\nPrimary endpoint:\n\nFor each patient, a score will be awarded based on the number of criteria (including calcium, phosphorus and calcium phosphate product) in the target international guidelines :0-1-2 or 3.\n\nThe primary endpoint will be the average scores in both groups at the beginning and the end of the study,\n\nMain secondary endpoints:\n\n* Changes in the number of patients responding to international guidelines for each of the three parameters studied (serum phosphate, corrected calcium, phosphorus product) in the 2 groups,\n* Evolution of Elecsys intact PTH Roche in the 2 groups,\n* Salaries and changes in the number of drugs to normalize the phospho-calcium balance in each group received,\n* cardiovascular events (morbidity and cardiovascular mortality),\n* Total mortality.\n\nStatistical analysis:\n\nThis is a randomized, two parallel arms. The investigators will compare the average number of criteria on calcium and phosphate in the target according to a Mann-Whitney. The analysis will be performed with the software Splus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* replacement therapy by hemodialysis for at least three months in the hemodialysis center of Nantes University Hospital,\n* intact PTH ≥ 100 pg / mL during the visit of inclusion.\n\nExclusion Criteria:\n\n* intact PTH \\<100 pg / mL during the visit of inclusion\n* Life expectancy estimated at less than one year at the time of inclusion, because of a disease diagnosed prior to the initiation of the study,\n* bone pathology diagnosed prior to the initiation of the study that interfere with calcium and phosphate metabolism (myeloma, Paget ...).'}, 'identificationModule': {'nctId': 'NCT02859220', 'acronym': 'PTH', 'briefTitle': 'Study of the Influence of Dosages of 1-84 and 7-84 Fragments of Parathyroid Hormone Compared to Conventional Dosage on the Balance of Calcium and Phosphate in Hemodialysis (PTH)', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Study of the Influence of Dosages of 1-84 and 7-84 Fragments of PTH Compared to Conventional Dosage on the Balance of Calcium and Phosphate in Hemodialysis', 'orgStudyIdInfo': {'id': 'BRD/05/12-C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'group 1', 'description': 'group 1 : Roche Elecsys intact PTH', 'interventionNames': ['Other: Determination of PTH following']}, {'type': 'OTHER', 'label': 'group 2', 'description': 'group 2 : PTH 1-84 complete (PAC) report and CAP / PTH 7-84 (CIP), Duo PTH IRMA Scantibodies', 'interventionNames': ['Other: Determination of PTH following:']}], 'interventions': [{'name': 'Determination of PTH following', 'type': 'OTHER', 'description': 'Determination of PTH following:\n\nin group 1: intact PTH Elecsys Roche', 'armGroupLabels': ['group 1']}, {'name': 'Determination of PTH following:', 'type': 'OTHER', 'description': 'PTH 1-84 complete (PAC) report and CAP / CIP, the package "Duo PTH IRMA Scantibodies." The CIP is obtained by calculating the difference between total intact PTH and PTH 1-84 in the kit used.', 'armGroupLabels': ['group 2']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}