Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT04445558
Status:
COMPLETED
Last Update Posted:
2022-01-05
First Post:
2020-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of 2 Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic Renal Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-04', 'studyFirstSubmitDate': '2020-06-19', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of the nutritional status', 'timeFrame': 'Month 6', 'description': 'The main endpoint is the evolution between M0 and M6 of the nutritional status measured by the serum albumin level.'}], 'secondaryOutcomes': [{'measure': 'Evolution of nutritional assessment', 'timeFrame': 'Month 6', 'description': 'Evolution of the percentage of weight loss (in Kg)'}, {'measure': 'Appearance of adverse events', 'timeFrame': 'Month 6', 'description': 'Incidence and characteristics of adverse events / effects'}, {'measure': 'Measure of the Quality of life', 'timeFrame': 'Month 6', 'description': 'Evolution of the quality of life, evaluated by the EORTC QLQ-C30 questionnaire of the quality of life with 28 questions with 4 possible answers from "not at all" to "a lot of"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Insufficiency']}, 'descriptionModule': {'briefSummary': 'Describe the impact of dialysis by high permeability and adsorbent membrane (PEPA®) associated with oral nutritional supplementation on the nutritional status of malnourished chronic end-stage renal disease patients dependent on intradialytic parenteral nutrition.', 'detailedDescription': 'The study proposes to compare the nutritional state after 6 months of dialysis with standard membrane associated with intradialytic parenteral nutrition (retrospective phase) with the nutritional state after 6 months of dialysis with high permeability membrane associated with oral nutritional supplementation (prospective phase).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with renal failure, on hemodialysis for at least 12 months;\n* Hemodialysis patient in 3 weekly sessions on a device with a standard permeability membrane (polysulfone, polyethersulfone or polyartylethersulfone type);\n* Malnourished patient, on intradialytic parenteral nutrition for at least 6 months;\n* Patient who may benefit, according to the doctor, from a change in dialysis and nutrition strategy:\n* Patient who signed an informed consent form to participate in the study\n\nExclusion Criteria:\n\n* Known allergy to PEPA® ;\n* Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);\n* Patient with a chronic infection in progress;\n* Patient with life expectancy \\<6 months according to the investigator;\n* Inability to understand information related to the study (linguistic, psychological, cognitive reason, etc.);\n* Pregnant woman or likely to be (of childbearing age, without effective contraception) or breastfeeding;\n* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;\n* Patient not benefiting from a social security scheme.'}, 'identificationModule': {'nctId': 'NCT04445558', 'briefTitle': 'Study of 2 Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic Renal Disease Patients', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Study of Two Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic End-stage Renal Disease Patients Dependent on Intradialytic Parenteral Nutrition', 'orgStudyIdInfo': {'id': '2020-A01267-32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Membrane PEPA®', 'description': 'Patient will use the membrane PEPA® for the dialysis', 'interventionNames': ['Dietary Supplement: oral nutritional supplementation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard membrane of dialysis', 'description': 'Patient will use a standard membrane for the dialysis', 'interventionNames': ['Dietary Supplement: intradialytic parenteral nutrition']}], 'interventions': [{'name': 'oral nutritional supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Adjunction of oral nutritional supplementation', 'armGroupLabels': ['Membrane PEPA®']}, {'name': 'intradialytic parenteral nutrition', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Adjunction of intradialytic parenteral nutrition', 'armGroupLabels': ['Standard membrane of dialysis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Privé La Louvière', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}