Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-28 @ 9:12 AM
Study NCT ID:
NCT02895061
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2016-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C008088', 'term': 'alfacalcidol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 502}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-29', 'studyFirstSubmitDate': '2016-09-04', 'studyFirstSubmitQcDate': '2016-09-04', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome was the difference of the mean PTH reduction between two groups at the end of the study by unpaired-T test.', 'timeFrame': '12 week', 'description': 'mean PTH reduction between two groups at the end of the study by unpaired-T test.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Alfacalcidol, Secondary Hyperparathyroidism, Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '15807187', 'type': 'BACKGROUND', 'citation': 'Gu Y, Ding F, Chen N, Mei CL, Qian JQ, Wang XY, Shi W, Hou FF, Li XW, Wang M, Chen YP. Comparisons between oral pulse alfacalcidol therapy and daily therapy in maintenance hemodialysis patients with secondary hyperparathyroidism: a randomized, controlled, and multicenter study. Ren Fail. 2005;27(2):205-12.'}, {'pmid': '16792136', 'type': 'RESULT', 'citation': 'Tarrass F, Yazidi A, Sif H, Zamd M, Benghanem MG, Ramdani B. A randomized trial of intermittent versus continuous oral alfacalcidol treatment of hyperparathyroidism in end-stage renal disease. Clin Nephrol. 2006 Jun;65(6):415-8. doi: 10.5414/cnp65415.'}, {'pmid': '9808139', 'type': 'RESULT', 'citation': 'Llach F, Yudd M. Pathogenic, clinical, and therapeutic aspects of secondary hyperparathyroidism in chronic renal failure. Am J Kidney Dis. 1998 Oct;32(2 Suppl 2):S3-12. doi: 10.1053/ajkd.1998.v32.pm9808139. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Primary objective was to evaluate the efficacy between daily and pulse oral alfacalcidol treatment of SHPT in chronic hemodialysis patients, a 12-week treatment. Secondary objective was to observe the adverse effects between these two treatment regimens.', 'detailedDescription': 'ESRD patients with secondary hyperparathyroidism in 3 hemodialysis centers were enrolled. They were assigned to either oral daily or pulse (trice a week) alfacalcidol treatments using block-of-4 randomization. Alfacalcidol in both groups were equal at the dose of 6 microgram per week. Clinical and laboratory data were obtained at baseline and were monitored every 4 weeks for 12 weeks. Primary outcome was the difference of the mean PTH reduction between two groups at the end of the study by unpaired-T test. All possible adverse events were carefully monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 y ESRD on HD KT/V ≥ 3.6/wk 2˚HPT Stable in P binder for 4 wk\n\nExclusion Criteria:\n\n* Alfacalcidol allergy Serum Ca ≥ 10.5 mg/dL Serum P ≥ 5.5 mg/dL Pregnancy On phenytoin, phenobarbital'}, 'identificationModule': {'nctId': 'NCT02895061', 'briefTitle': 'Effectiveness of Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Phramongkutklao College of Medicine and Hospital'}, 'officialTitle': 'Effectiveness Between Daily Versus Pulse Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients: A Randomized Controlled Trial and Multicenter Study', 'orgStudyIdInfo': {'id': 'PMK-0007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A: Daily', 'description': 'A: oral daily alfacalcidol treatments total 6 microgram/week', 'interventionNames': ['Drug: Alfacalcidol']}, {'type': 'EXPERIMENTAL', 'label': 'B: Pulse', 'description': 'B: pulse (trice a week) alfacalcidol treatments total 6 microgram/week', 'interventionNames': ['Drug: Alfacalcidol']}], 'interventions': [{'name': 'Alfacalcidol', 'type': 'DRUG', 'otherNames': ['oral daily alfacalcidol treatments total 6 microgram/week'], 'description': 'Alfacalcidol 1 microgram/capsule', 'armGroupLabels': ['A: Daily', 'B: Pulse']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phramongkutklao College of Medicine and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}