Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-03-01 @ 5:54 PM
Study NCT ID:
NCT00744302
Status:
COMPLETED
Last Update Posted:
2015-05-22
First Post:
2008-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of 1.25 mmol/L Calcium Dialysate on Mineral Metabolism in Haemodialysis Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D006934', 'term': 'Hypercalcemia'}, {'id': 'D002114', 'term': 'Calcinosis'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-20', 'studyFirstSubmitDate': '2008-08-28', 'studyFirstSubmitQcDate': '2008-08-28', 'lastUpdatePostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of mineral metabolism and remission of secondary hyperparathyroidism', 'timeFrame': '2006-2009'}], 'secondaryOutcomes': [{'measure': 'Improvement of cardiovascular calcification and decrease of clinical cardiovascular events', 'timeFrame': '2006-2009'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dialysate calcium', 'Mineral metabolism', 'Parathyroid hormone', 'Calcification', 'Cardiovascular disease', 'Haemodialysis'], 'conditions': ['Hyperparathyroidism', 'Hypercalcemia']}, 'descriptionModule': {'briefSummary': 'A prospective, randomized, controlled multicenter trial to evaluate 1.25 mmol/L (physiological) vs. 1.5 mmol/L calcium dialysate on serum markers of mineral metabolism, secondary hyperparathyroidism and cardiovascular calcification in prevalent haemodialysis patients. And the long term safety of the 1.25 mmol/L calcium dialysate was also considered.\n\nThere are two phases of study for each subject. Phase 1 (screening phase). During this phase, each potential subject will be evaluated to determine if he/she is eligible for the study.\n\nPhase 2 (intervention phase). Each subject will be randomly allocated to physiological calcium dialysate (1.25 mmol/L calcium dialysate) group (PCD group), and normal calcium dialysate (1.5 mmol/L calcium dialysate) group (NCD group). The follow-up duration was 36 months.', 'detailedDescription': 'All patients recruited from these centers who met the inclusion criteria were randomly allocated to physiological calcium dialysate (1.25 mmol/L calcium dialysate) group (PCD group), and normal calcium dialysate (1.5 mmol/L calcium dialysate) group (NCD group). The follow-up duration was 36 months.\n\nCalcium carbonate was mainly used as the phosphate binder. Active vitamin D metabolite, calcitriol (Rocaltrol, Hoffmann La Roche, and Basel, Switzerland) was given as to control the secondary hyperparathyroidism. The doses of these agents were adjusted according to the serum calcium level, serum phosphate level, calcium-phosphorus product and serum iPTH level, which were recommended by the K/DOQI Guidelines 6.3b and 8B. Aluminum hydroxide might be introduced as a phosphate binder for no more than 4 weeks in addition to calcium carbonate and dietary restriction when serum phosphate level could not get a good control (serum P level≥1.78 mmol/L, lasting above 4 weeks). A non- calcium-containing phosphate binder could be administered for 1\\~2 weeks in patients with hypercalcaemia during the observation. At the time of the study, non-calcium, non-aluminum based phosphate binders as well as calcium acetate were not available in our country.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willingness to sign an informed consent\n* Stable haemodialysis treatment for more than 3 months, undergoing 2 to 3 times haemodialysis a week for 4 to 5 hours per session\n* Secondary hyperparathyroidism defined as serum intact parathyroid hormone (iPTH) \\> 150 pg/mL, hypercalcemia defined as serum Ca \\> 2.2 mmol/L and /or calcium phosphate product ≥55mg2/dl2\n\nExclusion Criteria:\n\n* Inability or unwillingness to sign the informed consent\n* Cardiac arrhythmia\n* Serious renal osteopathy\n* Oral active vitamin D and/or calcium carbonate intolerance\n* Poor compliance or unwillingness to meet the scheme demands raised by the investigators\n* Patients who had undergone percutaneous ethanol injection therapy or parathyroidectomy for secondary hyperparathyroidism\n* Patients who had previously been treated and/or were being treated with glucocorticoid, which affects bone metabolism.'}, 'identificationModule': {'nctId': 'NCT00744302', 'briefTitle': 'Study of 1.25 mmol/L Calcium Dialysate on Mineral Metabolism in Haemodialysis Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Study of 1.25 mmol/L Calcium Dialysate on Mineral Metabolism in Haemodialysis Patients.', 'orgStudyIdInfo': {'id': 'SYSU-PRGHD-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PCD', 'description': 'Physiological calcium (1.25 mmol/L) dialysate therapy All subjects in the study phase will continue to take calcium carbonate and/or active vitamin D agents.', 'interventionNames': ['Drug: physiological (1.25 mmol/L ) calcium dialysate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NCD', 'description': 'Normal calcium (1.5 mmol/L) dialysate therapy All subjects in the study phase will continue to take calcium carbonate and/or active vitamin D agents.', 'interventionNames': ['Drug: physiological (1.25 mmol/L ) calcium dialysate']}], 'interventions': [{'name': 'physiological (1.25 mmol/L ) calcium dialysate', 'type': 'DRUG', 'description': 'Using the physiological calcium dialysate (1.25 mmol/L calcium dialysate)for Stable haemodialysis treatment for more than 3 months, undergoing 2 to 3 times haemodialysis a week for 4 to 5 hours per session', 'armGroupLabels': ['NCD', 'PCD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The 1st Affiliated Hospital, Sun Yet-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Xueqing Yu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University'}, {'name': 'Tanqi Luo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, 3rd Affiliated Hospital of Sun Yet-Sen University'}, {'name': 'Qiong Luo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, Shen Zhen Affiliated Hospital of Peking University'}, {'name': 'Yaozhong Kong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Nephrology, the 1st People's Hospital Fo Shan City"}, {'name': 'Wei Shi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of nephrology, People's Hospital of Guangdong Province"}, {'name': 'Haitang Hu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Nephrology, People's Hospital Shun De City"}, {'name': 'Zaiseng Zhou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Nephrology, People's Hospital of Zhongshan City"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xue Qing Yu', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}