Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-26 @ 5:29 PM
Study NCT ID:
NCT05333692
Status:
COMPLETED
Last Update Posted:
2022-04-19
First Post:
2022-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Nutritional Supplementation of Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-17', 'studyFirstSubmitDate': '2022-04-07', 'studyFirstSubmitQcDate': '2022-04-17', 'lastUpdatePostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Albumin level change', 'timeFrame': 'baseline, weerk 4 and week 8'}], 'secondaryOutcomes': [{'measure': 'Body Weight (kg) and Height(cm) change, and these results will be combine to report BMI (kg/m^2) change', 'timeFrame': 'baseline, weerk 4 and week 8'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemodialysis Complication']}, 'descriptionModule': {'briefSummary': 'This study is aimed to demonstrate that increase in serum albumin concentration (week 8 -baseline) after test treatment (Fresubin® Protein Energy DRINK), a standard ONS, is not relevantly smaller than that after control treatment with NEPRO®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 40-80 years\n2. Acute or chronic renal failure patients who need dialysis and already dialysis for 3 months at least.\n3. Malnutrition patients. Definition of Malnutrition is serum albumin level\\<3.5g/dL, calorie digestion below 35kcal/IBW or protein digestion below 1.2g/IBW.\n\nExclusion Criteria:\n\n1. BMI\\<18.5 and calorie intake unable to reach 50% of the recommended level\n2. BMI\\>30 kg/m2,\n3. abnormal liver function,\n4. malignant disease,\n5. scheduled surgery within a month or after surgery,\n6. infectious disease,\n7. suboptimal tolerance of nutritional supplements,\n8. inflammatory bowel disease, bowel obstruction,\n9. acute condition complicated with multiple organ failure or under palliative care.'}, 'identificationModule': {'nctId': 'NCT05333692', 'briefTitle': 'Oral Nutritional Supplementation of Hemodialysis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Kabi Taiwan Ltd.'}, 'officialTitle': 'Oral Nutritional Supplementation of Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'FrPE-005-IEN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NEPRO®', 'interventionNames': ['Dietary Supplement: NEPRO® , Abbott']}, {'type': 'EXPERIMENTAL', 'label': 'Fresubin® Protein Energy DRINK', 'interventionNames': ['Dietary Supplement: Fresubin® Protein Energy DRINK']}], 'interventions': [{'name': 'Fresubin® Protein Energy DRINK', 'type': 'DIETARY_SUPPLEMENT', 'description': '1-2 bottles of Fresubin® Protein Energy DRINK per day', 'armGroupLabels': ['Fresubin® Protein Energy DRINK']}, {'name': 'NEPRO® , Abbott', 'type': 'DIETARY_SUPPLEMENT', 'description': '2-4 cans NEPRO® per day', 'armGroupLabels': ['NEPRO®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40201', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Kabi Taiwan Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Chung Shan Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}