Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:13 PM
Study NCT ID:
NCT00397358
Status:
WITHDRAWN
Last Update Posted:
2025-03-03
First Post:
2006-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077607', 'term': 'Icodextrin'}, {'id': 'D015314', 'term': 'Dialysis Solutions'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2006-11-07', 'studyFirstSubmitQcDate': '2006-11-08', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in fasting triglyceride levels.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peritoneal Dialysis', 'Hypertriglyceridemia', 'Extraneal(7.5% icodextrin)Peritoneal Dialysis Solution'], 'conditions': ['Peritoneal Dialysis', 'Hypertriglyceridemia']}, 'referencesModule': {'references': [{'pmid': '10911641', 'type': 'BACKGROUND', 'citation': 'Holmes CJ, Shockley TR. Strategies to reduce glucose exposure in peritoneal dialysis patients. Perit Dial Int. 2000;20 Suppl 2:S37-41.'}, {'pmid': '11475343', 'type': 'BACKGROUND', 'citation': 'Bredie SJ, Bosch FH, Demacker PN, Stalenhoef AF, van Leusen R. Effects of peritoneal dialysis with an overnight icodextrin dwell on parameters of glucose and lipid metabolism. Perit Dial Int. 2001 May-Jun;21(3):275-81.'}, {'pmid': '15980620', 'type': 'BACKGROUND', 'citation': 'Martikainen T, Teppo AM, Gronhagen-Riska C, Ekstrand A. Benefit of glucose-free dialysis solutions on glucose and lipid metabolism in peritoneal dialysis patients. Blood Purif. 2005;23(4):303-10. doi: 10.1159/000086553. Epub 2005 Jun 23.'}, {'pmid': '12694323', 'type': 'BACKGROUND', 'citation': 'Kronenberg F, Lingenhel A, Neyer U, Lhotta K, Konig P, Auinger M, Wiesholzer M, Andersson H, Dieplinger H. Prevalence of dyslipidemic risk factors in hemodialysis and CAPD patients. Kidney Int Suppl. 2003 May;(84):S113-6. doi: 10.1046/j.1523-1755.63.s84.23.x.'}, {'pmid': '11510303', 'type': 'BACKGROUND', 'citation': 'Amici G, Orrasch M, Da Rin G, Bocci C. Hyperinsulinism reduction associated with icodextrin treatment in continuous ambulatory peritoneal dialysis patients. Adv Perit Dial. 2001;17:80-3.'}, {'pmid': '16221697', 'type': 'BACKGROUND', 'citation': 'Furuya R, Odamaki M, Kumagai H, Hishida A. Beneficial effects of icodextrin on plasma level of adipocytokines in peritoneal dialysis patients. Nephrol Dial Transplant. 2006 Feb;21(2):494-8. doi: 10.1093/ndt/gfi197. Epub 2005 Oct 12.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase IV study evaluating triglyceride levels in peritoneal dialysis patients.', 'detailedDescription': 'This prospective, open label, multi-center study evaluates the use of 7.5% icodextrin used in the long-dwell exchange in peritoneal dialysis patients with elevated triglyceride levels. Fasting triglyceride levels will be measured during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent\n* CAPD/APD on dialysis for at least 3 months\n* Elevated fasting triglyceride levels\n\nExclusion Criteria:\n\n* enrolled in another study requiring IRB approval\n* allergy to starch-based polymers\n* glycogen storage disease\n* maltose or isomaltose intolerance\n* active alcohol/substance abuse\n* Pregnant or nursing\n* received an investigational drug within 30 days of screening'}, 'identificationModule': {'nctId': 'NCT00397358', 'briefTitle': 'Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vantive Health LLC'}, 'officialTitle': 'Open-label Study to Evaluate the Effects of Once Daily Extraneal (7.5% Icodextrin) Peritoneal Dialysis Solution on Triglyceride Levels in Peritoneal Dialysis Patients', 'orgStudyIdInfo': {'id': '31656'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Extraneal (7.5% icodextrin) Peritoneal Dialysis Solution', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95051', 'city': 'Santa Clara', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Santa Clara - Homestead', 'geoPoint': {'lat': 37.35411, 'lon': -121.95524}}, {'zip': '46360', 'city': 'Michigan City', 'state': 'Indiana', 'country': 'United States', 'facility': 'Nephrology Specialists', 'geoPoint': {'lat': 41.70754, 'lon': -86.89503}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Dialysis Center of Lincoln', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], 'overallOfficials': [{'name': 'Baxter Healthcare Corporation', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Call central contact for information'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vantive Health LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}