Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-03-01 @ 1:47 AM
Study NCT ID:
NCT04086212
Status:
WITHDRAWN
Last Update Posted:
2024-10-01
First Post:
2019-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine
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': 'D000077607', 'term': 'Icodextrin'}, {'id': 'D014993', 'term': 'Xylitol'}, {'id': 'D010530', 'term': 'Peritoneal Dialysis'}, {'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': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006435', 'term': 'Renal Dialysis'}, {'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized cross-over, controlled, open label.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study never started', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2019-09-02', 'studyFirstSubmitQcDate': '2019-09-10', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Net-ultrafiltration', 'timeFrame': 'Changes from baseline value at the end of each product administration period (3 days)', 'description': 'Net Ultrafiltration at 10 hours (duration of long dwell), in mL, is defined as the difference between the weight of drained volume and weight of the effluent (fill volume).'}], 'secondaryOutcomes': [{'measure': 'Sodium removal', 'timeFrame': 'Calculated every day for 3 days during each product administration period.', 'description': 'Net sodium removal will be calculated as the difference between the total amount of sodium drained at end of long dwell (10 hours) and its measure value in the dialysate at time 0 before the initial infusion. Sodium will determined by the hospital laboratory.'}, {'measure': 'Carnitine plasmatic level', 'timeFrame': 'Every day for 3 days during each product administration and during the wash-out period', 'description': "Carnitine plasmatic level is assessed by chemical analysis of patient's plasma samples."}, {'measure': 'Xylitol plasmatic level', 'timeFrame': 'Every day for 3 days during each product administration and during the wash-out period.', 'description': "Xylitol plasmatic leve is assessed by chemical analysis of patient's plasma samples."}, {'measure': 'Xylitol absorption', 'timeFrame': 'Every day for 3 days during each product administration', 'description': "Xilitol absorption is determined by calculating the difference (in grams) between the amount of xylitol (measured by lab analysis) in plasma and the amount of xylitol in the patient's dialysis solution administered."}, {'measure': 'Adverse Events', 'timeFrame': 'Through study completion, an average of 21 days.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['End Stage Renal Disease (ESRD)']}, 'descriptionModule': {'briefSummary': 'Randomized, cross-over, controlled, open label study. The aim of this study is to demonstrate that glucose may completely be replaced by a combination of xylitol and carnitine in the bimodal PD solution for long dwell exchange.', 'detailedDescription': 'The use of a solution icodextrin, xylitol and carnitine (IXC) as the osmotic agent in dialysate for the long dwell exchange provides sustained ultrafiltration (UF) through colloid osmosis, allowing a consistent reduction in extracellular fluid volume without the expected fall in urine output. The other major advantage of IXC is the reduced exposure and absorption of glucose as the main osmotic agent in PD therapy. The aim of this study is to demonstrate that glucose may completely be replaced by a combination of xylitol and carnitine in the bimodal IXC-based PD solution. Compared to glucose, indeed, carnitine and xylitol are extremely stable naturally occurring compounds, even at temperatures higher than those used to steam-sterilize infusional product. As a consequence, xylitol and carnitine may represent better alternatives than glucose as an osmotic ingredient both from the manufacturing and biocompatibility standpoints. Moreover, xylitol and carnitine have an excellent safety profile and possess distinct systemic actions, which are more favorable than glucose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD) for at least 3 months\n* A stable clinical condition during the two weeks immediately prior to randomization\n* Blood hemoglobin concentration above 8,5 g/100ml\n* Has not experienced peritonitis episodes in the last 3 months\n* Treated with Extraneal for at least 1 month\n* Peritoneal Equilibration Test (PET) performed in the last three months\n* Has understood and signed the Informed Consent Form.\n\nExclusion Criteria:\n\n* History of drug or alcohol abuse in the six months prior to entering the protocol\n* Acute infectious condition\n* History of severe congestive heart failure and clinically significant arrhythmia\n* Malignancy within the past 5 years, including lymphoproliferative disorders\n* A medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug\n* A clinically relevant under-hydration as judged by the treating physician\n* History of L-Carnitine therapy or use in the month before entering the study\n* Received any investigational drug in the 3 months before entering the study\n* Pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive measures"}, 'identificationModule': {'nctId': 'NCT04086212', 'briefTitle': 'Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Iperboreal Pharma Srl'}, 'officialTitle': 'Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine Compared to Icodextrin Alone, an Exploratory Study.', 'orgStudyIdInfo': {'id': 'IP-001-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IXC Peritoneal dialysis solution', 'description': 'IXC (Icodextrin, Xylitol and L-Carnitine) Peritoneal dialysis solution', 'interventionNames': ['Drug: Icodextrin, xylitol and carnitine solution for peritoneal dialysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Icodextrin', 'description': 'Extraneal® (7.5% Icodextrin) Peritoneal dialysis solution', 'interventionNames': ['Drug: EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution']}], 'interventions': [{'name': 'Icodextrin, xylitol and carnitine solution for peritoneal dialysis', 'type': 'DRUG', 'otherNames': ['IXC'], 'description': 'Patients will receive a long dwell exchange for three days.', 'armGroupLabels': ['IXC Peritoneal dialysis solution']}, {'name': 'EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution', 'type': 'DRUG', 'otherNames': ['icodextrin'], 'description': 'Patients will receive a long dwell exchange for three days.', 'armGroupLabels': ['Icodextrin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mario Bonomini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Nephrology, University of Chieti, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iperboreal Pharma Srl', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}