Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-03-04 @ 11:11 PM
Study NCT ID:
NCT01994733
Status:
COMPLETED
Last Update Posted:
2015-06-23
First Post:
2013-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002119', 'term': 'Calcium Carbonate'}], 'ancestors': [{'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-22', 'studyFirstSubmitDate': '2013-11-20', 'studyFirstSubmitQcDate': '2013-11-25', 'lastUpdatePostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum phosphate concentration', 'timeFrame': '26 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of patients who successfully achieved target serum P at week 26 based on the arm to which they were randomized', 'timeFrame': '26 weeks'}, {'measure': 'Treatment compliance as defined by taking the study medication at least 80% of the time', 'timeFrame': '26 weeks'}, {'measure': 'Number of serious adverse events', 'timeFrame': '26 weeks'}, {'measure': 'Number of hospitalizations for vascular reasons that are unrelated to dialysis access', 'timeFrame': '26 weeks'}, {'measure': 'Proportion of patients with a vascular death or non-fatal vascular event', 'timeFrame': '26 weeks'}, {'measure': 'Proportion of patients developing serum calcium > 2.60 mmol/L', 'timeFrame': '26 weeks'}, {'measure': 'Number of fractures', 'timeFrame': '26 weeks'}, {'measure': 'Number of patients developing calcific uremic arteriolopathy (ie, calciphylaxis)', 'timeFrame': '26 weeks'}, {'measure': 'Change in quality-of-life', 'timeFrame': '26 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['end-stage renal disease', 'hemodialysis', 'mineral metabolism', 'serum phosphate', 'phosphate binders'], 'conditions': ['End-stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'Patients with end-stage renal disease (ESRD) who have elevated serum phosphate (P) levels have significantly higher mortality rates compared to those with normal P. In patients receiving conventional dialysis regimens, serum P may be lowered through dietary intervention and use of P binders, though these have potentially important side effects and may adversely impact quality of life. Whether lowering P, and / or targeting specific P levels improve survival and clinical outcomes is unknown. Despite this uncertainty, over 90% of patients with ESRD receive P lowering therapy and guidelines for the care of patients with ESRD are increasingly calling for more aggressive phosphate lowering. This intensive P lowering results in extra medications (and their associated side-effects), and higher health care costs. We are uncertain whether the intensification of P control results in measurable benefits to patients with ESRD. The overall goal of this pilot trial is to evaluate the feasibility of conducting a randomized controlled trial of intensive vs liberalized phosphate control among hemodialysis recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 yrs\n2. Receiving chronic hemodialysis for \\> 90 days,\n3. Dialysis prescription is currently no more than 4 sessions per week and prescribed as 3-5 hrs per session\n4. Most recent P value 1.30-2.50 mmol/L\n5. Receipt of a calcium-based P binder\n\nExclusion Criteria:\n\n1. Patient is booked (with a known surgical date) for a live donor kidney transplant in the next 26 weeks\n2. Planned switch to a dialysis schedule that involves \\> 16 hours per week of therapy within the next 26 weeks.\n3. Planned switch to peritoneal dialysis within the next 26 weeks\n4. Pregnancy\n5. Albumin-corrected serum calcium \\> 2.60 mmol/L in the past year requiring reduction of the calcium carbonate dose\n6. History of calciphylaxis\n7. Attending nephrologist believes that an otherwise eligible patient is mandated- on clinical grounds- to have a P value that is targeted to \\< 1.50 mmol/L or \\> 2.00 mmol/L\n8. Attending nephrologist believes an otherwise eligible patient is not a candidate for escalation of the current calcium dose\n9. Co-enrollment in a clinical trial where the intervention is deemed to interfere with the adherence, safety or efficacy of the intervention provided herein'}, 'identificationModule': {'nctId': 'NCT01994733', 'acronym': 'TARGET', 'briefTitle': 'Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET)', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET): Intensive vs Liberalized Phosphate Control in Hemodialysis Recipients', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive phosphate control', 'description': 'Individuals randomized to this arm will be exposed to a treatment strategy that targets a P of \\< 1.50 mmol/L, reflecting the recommendations of current guidelines. Titration of the calcium carbonate dose will be the core of this approach and this will be complemented by usual recommendations regarding dietary P restriction. Dietitians will be available to provide counseling with regards to any aspect of the end-stage renal disease diet, as per usual dialysis unit practice.', 'interventionNames': ['Drug: Calcium carbonate ( Intensive phosphate control)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Liberalized phosphate control', 'description': 'Individuals in this arm will be exposed to a treatment strategy that allows P to rise above 2.00 mmol/L. This will be accomplished through structured reduction of P binders already in use (as per the algorithm detailed below). "Rescue" P binding will be instituted if P rises above 2.50 mmol/L. Dietitians will be available to provide counseling regarding any aspect of the end-stage renal disease diet, as per usual dialysis unit practice, but will not provide counseling on dietary P restriction unless the P rises above 2.50 mmol/L.', 'interventionNames': ['Drug: Calcium carbonate (Liberalized phosphate control)']}], 'interventions': [{'name': 'Calcium carbonate ( Intensive phosphate control)', 'type': 'DRUG', 'otherNames': ['Calcium carbonate'], 'description': 'Individuals randomized to this arm will be exposed to a treatment strategy that targets a P of \\< 1.50 mmol/L, reflecting the recommendations of current guidelines. Titration of the calcium carbonate dose will be the core of this approach and this will be complemented by usual recommendations regarding dietary P restriction. Dietitians will be available to provide counseling with regards to any aspect of the end-stage renal disease diet, as per usual dialysis unit practice', 'armGroupLabels': ['Intensive phosphate control']}, {'name': 'Calcium carbonate (Liberalized phosphate control)', 'type': 'DRUG', 'description': 'Individuals in this arm will be exposed to a treatment strategy that allows P to rise above 2.00 mmol/L. This will be accomplished through structured reduction of P binders already in use (as per the algorithm detailed below). "Rescue" P binding will be instituted if P rises above 2.50 mmol/L. Dietitians will be available to provide counseling regarding any aspect of the end-stage renal disease diet, as per usual dialysis unit practice, but will not provide counseling on dietary P restriction unless the P rises above 2.50 mmol/L.', 'armGroupLabels': ['Liberalized phosphate control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Medical Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Capital District Health Authority', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Healthcare", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6G 2V4', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Ron Wald, MDCM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Staff Physician, Division of Nephrology; Scientist, Li Ka Shing Knowledge Institute of St. Michael's Hospital", 'investigatorFullName': 'Ron Wald', 'investigatorAffiliation': 'Unity Health Toronto'}}}}