Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-31 @ 8:49 AM
Study NCT ID:
NCT00755404
Status:
WITHDRAWN
Last Update Posted:
2019-06-26
First Post:
2008-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of an L-Carnitine-Containing Peritoneal Dialysis (PD) Solution on Insulin Sensitivity in Diabetic Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], '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'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-24', 'studyFirstSubmitDate': '2008-09-18', 'studyFirstSubmitQcDate': '2008-09-18', 'lastUpdatePostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by measuring insulin requirement', 'timeFrame': 'time 0, 6 months'}], 'secondaryOutcomes': [{'measure': 'To assess the efficacy of L-Carnitine containing PD solution on plasma lipids and lipoprotein profile', 'timeFrame': '4 weeks, time 0, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months'}, {'measure': 'To assess the efficacy of L-Carnitine containing PD solution on hematological parameters (hemoglobin and EPO requirements)', 'timeFrame': '2 weeks, time 0, 3 months, 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peritoneal dialysis', 'L-carnitine', 'Diabetes', 'Glucose homeostasis', 'Dyslipidemia'], 'conditions': ['End Stage Renal Disease', 'Diabetes']}, 'descriptionModule': {'briefSummary': 'The current study is initiated in order to assess the impact of a PD solution containing L-carnitine on insulin sensitivity evaluated by measuring insulin requirement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18 years\n2. Have a diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) for at least 3 months\n3. Have Type 2 Diabetes, diagnosed according to American Diabetes Association (fasting glucose ≥126 mg/dl and 2 h glucose at OGTT ≥200 mg/dl), and treated with multiple daily insulin injection or with HbA1c \\> 8.5% (No oral antidiabetic)\n4. Be in a stable clinical condition during the four weeks immediately prior to Screening Period as demonstrated by medical history, physical examination and laboratory testing\n5. Have a blood hemoglobin concentration above 8,5 g/100ml (data will be verified with Investigators)\n6. Have not experienced peritonitis episodes in the last 3 months\n7. Be treated with Extraneal (nocturnal exchange bag solution) for at least 1 month\n8. Be treated with 3 diurnal exchange bag solutions (solution bags with 1.5% or 2.5% glucose) and one nocturnal exchange bag solution (Extraneal)\n9. Have Kt/V urea measurement \\> 1.7 per week in a previous test performed within 3 months that should be confirmed at Baseline Visit\n10. Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Baseline Visit\n11. Have a D/P Creatinine ratio at Peritoneal Equilibration Test (PET) between 0.50 and 0.81 in a previous test performed within 6 months that should be confirmed at Baseline Visit\n12. Have a D/P Glucose ratio at Peritoneal Equilibration Test (PET) between 0.26 and 0.49 in a previous test performed within 6 months that should be confirmed at Baseline Visit\n13. Be treated by the participating clinical Investigator for a period of at least three months\n14. Have understood and signed the Informed Consent Form.\n\nExclusion Criteria:\n\n1. Have a history of drug or alcohol abuse in the six months prior to entering the protocol\n2. Type 2 Diabetic patients under oral antidiabetic treatment with HbA1C \\< 8.5%\n3. Be in treatment with androgens\n4. Have clinically significant abnormal liver function test (SGOT, SGPT, and gamma-GT \\> 2 times the upper normal limit)\n5. Have acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)\n6. Have a history of congestive heart failure and clinically significant arrhythmia\n7. Have an history of epilepsy or any CNS disease\n8. Have malignancy within the past 5 years, including lymphoproliferative disorders\n9. Have any medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug\n10. Have a history of L-Carnitine therapy or use in the month prior to entering the protocol\n11. Have used any investigational drug in the 3 months prior to entering the protocol\n12. Be in pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive means"}, 'identificationModule': {'nctId': 'NCT00755404', 'briefTitle': 'Effect of an L-Carnitine-Containing Peritoneal Dialysis (PD) Solution on Insulin Sensitivity in Diabetic Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Iperboreal Pharma Srl'}, 'officialTitle': 'Phase 2 Study of the Effect of a Peritoneal Dialysis Solution Containing Glucose (1.5%) and L-Carnitine (0.1%) on Insulin Sensitivity in Patients on Continuous Ambulatory Peritoneal Dialysis', 'orgStudyIdInfo': {'id': 'IP-003-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: PD Solution']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: PD solution containing L-carnitine']}], 'interventions': [{'name': 'PD Solution', 'type': 'DRUG', 'description': 'Instillation of PD solutions containing Glucose (1.5 or 2.5%, w/v) for the diurnal exchanges, and 1 PD solution containing icodextrin (7.5 w/v) for nocturnal exchange. PD solutions are instilled for 180 days.', 'armGroupLabels': ['A']}, {'name': 'PD solution containing L-carnitine', 'type': 'DRUG', 'description': 'Instillation of PD solutions containing Glucose (1.5 or 2.5%, w/v) and L-carnitine (0.1%, w/v) for the diurnal exchanges, and 1 PD solution containing icodextrin (7.5 w/v) for nocturnal exchanges. PD solutions are instilled for 180 days.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'Renal, Dialysis and Transplant Unit, University of Bari', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '66100', 'city': 'Chieti', 'country': 'Italy', 'facility': 'Division of Nephrology, University of "G. d\'Annunzio"', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'zip': '20100', 'city': 'Desio', 'country': 'Italy', 'facility': 'Nephrology and Dialysis Unit, Desio Hospital', 'geoPoint': {'lat': 45.61831, 'lon': 9.20249}}, {'zip': '64021', 'city': 'Giulianova', 'country': 'Italy', 'facility': 'Nephrology and Dialysis Unit, "Maria SS dello Splendore" Hospital', 'geoPoint': {'lat': 42.75381, 'lon': 13.9665}}, {'zip': '20121', 'city': 'Milan', 'country': 'Italy', 'facility': 'Division of Nephrology and Dialysis, Ospedale Policlinico Maggiore', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '66026', 'city': 'Ortona', 'country': 'Italy', 'facility': 'Nephrology and Dialysis Unit, "G. Bernabeo" Hospital', 'geoPoint': {'lat': 42.35087, 'lon': 14.40342}}, {'zip': '20099', 'city': 'Sesto San Giovanni', 'country': 'Italy', 'facility': 'Renal Unit, Policlinico MultiMedica', 'geoPoint': {'lat': 45.53329, 'lon': 9.22585}}, {'zip': '64100', 'city': 'Teramo', 'country': 'Italy', 'facility': 'Division of Nephrology and Dialysis, "Mazzini" Hospital', 'geoPoint': {'lat': 42.66123, 'lon': 13.69901}}], 'overallOfficials': [{'name': 'Francesco P Schena, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bari'}, {'name': 'Arduino Arduini, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Iperboreal Pharma Srl'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iperboreal Pharma Srl', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}