Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-03 @ 12:10 AM
Study NCT ID:
NCT06580093
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-26
First Post:
2024-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Status in Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2024-08-28', 'studyFirstSubmitQcDate': '2024-08-28', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Malnutrition diagnosis', 'timeFrame': 'From Aug/Sept 2024 to May 2025', 'description': 'Malnutition diagnosis according to GLIM'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From Aug/Sept 2024 to Dec 28', 'description': 'Overall survival'}, {'measure': 'Muscle strength', 'timeFrame': 'From Aug/Sept 2024 to May 2025', 'description': 'Hand grip muscle strength'}, {'measure': 'Health related quality of life', 'timeFrame': 'Aug/Sept 2024 (baseline)', 'description': 'Health related quality of life according to RAND36'}, {'measure': 'Muscle mass', 'timeFrame': 'From Aug/Sept 2024 to May 2025', 'description': 'Muscle mass according to Bioimpedance Spectroscopy and Calf circumference'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Malnutrition', 'Muscle mass', 'GLIM'], 'conditions': ['Malnutrition']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to investigate how the GLIM criteria\\* for the diagnosis of malnutrition should be operationalized in patients with chronic kidney disease (CKD) treated with hemodialysis. The main questions it aims to answer are:\n\n* How can malnutrition be defined when applying different combinations and operationalization strategies of the GLIM criteria?\n* How can information from other nutrition assessment tools be used in the operationalization of GLIM?\n* Which combinations and operationalization strategies of the GLIM criteria can best predict deterioration in quality of life, muscle strength, and increased mortality? An observational study on patients with CKD in hemodialysis will be performed. Variables will be extracted from the Swedish renal registry, SNR and medical records at two hemodialysis units at one university hospital in Sweden. With start in the fall of 2024, data will be collected during two timepoints (baseline and follow-up) when wanted variables for this study are routinely measured at the units.\n\n * The Global Leadership Initiative on Malnutrition (GLIM) criteria to diagnose malnutrition in adults'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Chronic Kidney Disease (CKD) treated with hemodialysis at one university hospital in Sweden.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years\n* dialysis duration \\>3 months prior to recruitment\n\nExclusion Criteria:\n\n* patients who only have a dialysis frequency of once a week\n* patients treated with a combination of peritoneal dialysis and hemodialysis or treated at home\n* patients were written consent cannot be obtained due to medical or mental illness or weakened state of health'}, 'identificationModule': {'nctId': 'NCT06580093', 'briefTitle': 'Nutritional Status in Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Nutritional Status and Nutritional Problems in Patients With Chronic Kidney Disease Treated With Hemodialysis', 'orgStudyIdInfo': {'id': '2024-03363-01'}, 'secondaryIdInfos': [{'id': '2022-06295', 'type': 'OTHER_GRANT', 'domain': 'The Swedish Research Council'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Sandra Einarsson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umeå University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uppsala University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}