Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-01-10 @ 1:32 PM
Study NCT ID:
NCT06398002
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Increasing Dialysate Calcium on T50 in Subjects With Secondary Hyperparathyroidism and ESKD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Blinding of participants and investigators. Dialysis nurses will be aware of treatment assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised, double-blind, parallel-group, controlled clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-30', 'studyFirstSubmitDate': '2024-04-30', 'studyFirstSubmitQcDate': '2024-04-30', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in serum calcification propensity (T50)', 'timeFrame': '28 days', 'description': 'Between-groups difference in T50 at day 28 adjusted for T50 at day 0'}], 'secondaryOutcomes': [{'measure': 'Difference in bone-specific alkaline phosphatase (bALP)', 'timeFrame': '28 days', 'description': 'Between-groups difference in bALP at day 28 adjusted for bALP at day 0'}, {'measure': 'Difference in procollagen 1 intact N-terminal propeptide (P1NP)', 'timeFrame': '28 days', 'description': 'Between-groups difference in P1NP at day 28 adjusted for P1NP at day 0'}, {'measure': 'Difference in tartrate-resistant acid phosphatase 5b (TRAcP 5b)', 'timeFrame': '28 days', 'description': 'Between-groups difference in TRAcP 5b at day 28 adjusted for TRAcP 5b at day 0'}, {'measure': 'Difference in parathyroid hormone (PTH)', 'timeFrame': '28 days', 'description': 'Between-groups difference in PTH at day 28 adjusted for PTH at day 0'}, {'measure': 'Difference in calciprotein monomers (CPM)', 'timeFrame': '28 days', 'description': 'Between-groups difference in CPM at day 28 adjusted for CPM at day 0'}, {'measure': 'Difference in primary calciprotein particles (CPP-1)', 'timeFrame': '28 days', 'description': 'Between-groups difference in CPP-1 at day 28 adjusted for CPP-1 at day 0'}, {'measure': 'Difference in primary calciprotein particles (CPP-2)', 'timeFrame': '28 days', 'description': 'Between-groups difference in CPP-2 at day 28 adjusted for CPP-2 at day 0'}, {'measure': 'Difference in plasma ionised calcium (iCa)', 'timeFrame': '28 days', 'description': 'Between-groups difference in iCa at day 28 adjusted for iCa at day 0'}, {'measure': 'Difference in plasma phosphate (PO4)', 'timeFrame': '28 days', 'description': 'Between-groups difference in PO4 at day 28 adjusted for PO4 at day 0'}, {'measure': 'Difference in plasma magnesium (Mg)', 'timeFrame': '28 days', 'description': 'Between-groups difference in Mg at day 28 adjusted for Mg at day 0'}, {'measure': 'Difference in all above variables', 'timeFrame': '28 days', 'description': 'Within-groups difference in all above variables at day 28 adjusted for values at day 0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Secondary Hyperparathyroidism', 'End-stage Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Patients with end-stage kidney disease (ESKD) have an increased risk of cardiovascular mortality. High parathyroid hormone (PTH) from secondary hyperparathyroidism leads to increased efflux of phosphate and calcium from bone, which exacerbates vascular calcification and increases the risk of bone fractures. The main driving factor for secondary hyperparathyroidism is hypocalcaemia caused by low levels of 1,25-dihydroxy vitamin D and pharmacological supplementation with activated vitamin D and oral calcium-containing phosphate-binders are used to control secondary hyperparathyroidism. The amount of calcium used in this context is controversial, as higher calcium load in blood may theoretically increase vascular calcification. Conversely, by alleviating the efflux of phosphate and calcium from bone due to secondary hyperparathyroidism, increasing the load of calcium might actually prevent vascular calcification.\n\nTo study this further, we wish to conduct a randomised double-blinded controlled clinical trial of increasing dialysate Ca from 1.25 mmol/L (standard dialysate concentration) to 1.50 mmol/L in patients with ESKD and secondary hyperparathyroidism on maintenance haemodialysis (HD). The overall effect of increased dialysate calcium will be gauged by its effect on serum calcification propensity (T50) and on markers of bone turnover.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Treatment with thrice-weekly maintenance HD for ESKD for \\> 3 months.\n* Dialysate calcium of 1.25 mmol/L (standard concentration).\n* Plasma ionised calcium \\< 1.35 mmol/L (average of last 3 months).\n* Plasma intact PTH \\> 14 ρmol/L.\n* Plasma total alkaline phosphatase \\>90 U/L\n* Negative pregnancy test and use of highly effective and safe contraception.\n* Able to give written informed consent.\n\nExclusion Criteria:\n\n* Treatment with peritoneal dialysis.\n* Clinical bone fracture within the last 6 months.\n* Treatment with bisphosphonates, denosumab, romosozumab, or teriparatide within the last 3 months.\n* Other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of the trial.\n* Pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT06398002', 'acronym': 'CaT50HD', 'briefTitle': 'The Effect of Increasing Dialysate Calcium on T50 in Subjects With Secondary Hyperparathyroidism and ESKD', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'The Effect of Increasing Dialysate Calcium on Serum Calcification Propensity in Subjects With Secondary Hyperparathyroidism and End-Stage Kidney Disease', 'orgStudyIdInfo': {'id': 'CaT50HD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dialysate calcium 1.25 mmol/L (standard)', 'interventionNames': ['Other: Dialysate calcium 1.50 mmol/L']}, {'type': 'EXPERIMENTAL', 'label': 'Dialysate calcium 1.50 mmol/L (high)', 'interventionNames': ['Other: Dialysate calcium 1.50 mmol/L']}], 'interventions': [{'name': 'Dialysate calcium 1.50 mmol/L', 'type': 'OTHER', 'description': 'Increased dialysate calcium of 1.50 mmol/L (as compared to standard dialysate calcium of 1.25 mmol/L)', 'armGroupLabels': ['Dialysate calcium 1.25 mmol/L (standard)', 'Dialysate calcium 1.50 mmol/L (high)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Iain Bressendorff, MD PhD', 'role': 'CONTACT', 'email': 'iain.oshoej.bressendorff@regionh.dk', 'phone': '+4524277139'}, {'name': 'Ditte Hansen, MD PhD', 'role': 'CONTACT', 'email': 'ditte.hansen.04@regionh.dk', 'phone': '+4538682056'}], 'overallOfficials': [{'name': 'Iain Bressendorff, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herlev and Gentofte Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'Upon reasonable request to the investigators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iain Bressendorff', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Iain Bressendorff', 'investigatorAffiliation': 'Herlev Hospital'}}}}