Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-31 @ 1:46 AM
Study NCT ID:
NCT05030168
Status:
UNKNOWN
Last Update Posted:
2021-09-01
First Post:
2020-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Low Protein Diet Supplemented With Ketoanalogues on Preservation of Kidney Function in Incremental Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C048995', 'term': 'ketosteril'}, {'id': 'D018753', 'term': 'Diet, Protein-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-27', 'studyFirstSubmitDate': '2020-10-12', 'studyFirstSubmitQcDate': '2021-08-27', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'residual renal function', 'timeFrame': '12 months', 'description': 'To demonstrate superiority effect of incremental hemodialysis (HD) protocol (initiate with once-weekly hemodialysis) plus ketoanalogues-supplemented low-protein diet during non-dialysis days over the standard HD protocol (initiate with twice weekly hemodialysis) on preservation of residual renal function (renal urea clearance) at 12 months.'}], 'secondaryOutcomes': [{'measure': 'visceral protein', 'timeFrame': '12 months', 'description': 'To compare serum albumin levels between the two treatment groups over 12 months.'}, {'measure': 'structural protein', 'timeFrame': '12 months', 'description': 'To compare muscle mass between the two treatment groups over 12 months.'}, {'measure': 'muscle function', 'timeFrame': '12 months', 'description': 'To compare muscle strength between the two treatment groups over 12 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Function', 'Hemodialysis']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesized that combination of incremental hemodialysis and ketoanologues will better preserve residual kidney function and maintenance of nutritional status among the incident ESRD patients during the early initiation of chronic dialysis. This hypothesis has been a new concept of chronic hemodialysis initiation for End stage renal disease (ESRD) patients', 'detailedDescription': 'The investigators plan to conduct the first randomized Phase IIA clinical trial to investigate the efficacy of incremental hemodialysis and moderately low protein diet combined with ketoanologues supplementation on preservation of residual kidney function, inflammatory status and nutritional parameters among incident chronic dialysis patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years at screening\n* Stable CKD stage 5 not yet on dialysis with residual kidney function 5-10 ml/min/1.73m2 by CKD-EPI equation\n* Urine output ≥ 800 ml/day\n* Willing to participate in the study and can provide inform consent\n\nExclusion Criteria:\n\n* Rapid glomerular filtration rate (GFR) progression defined as a decline of eGFR \\>10 ml/min/1.73m2 by CKD-EPI equation in the prior 6 months before enrollment\n* Presence of wasting diseases, cancer cachexia, tuberculosis, AIDS wasting syndrome\n* Other active infection/inflammation determined by CRP \\>10 mg/L\n* Severe gastrointestinal problem: persistent nausea/vomiting, dysphagia, chronic diarrhea, severe malabsorption\n* Conditions at baseline requiring withdrawal from the study including severe protein energy wasting by SGA and MIS score, prior kidney transplantation with immunosuppressive agents or other serious medical conditions.\n* Pregnancy\n* Uncontrolled hypercalcemia (persistent serum Ca ≥10.5 mg/dl)\n* BMI ≥ 35 kg/m2\n* Hypersensitivity to the active substances or to any of the excipients of Ketosteril\n* Disturbed amino acid metabolism'}, 'identificationModule': {'nctId': 'NCT05030168', 'briefTitle': 'Effects of Low Protein Diet Supplemented With Ketoanalogues on Preservation of Kidney Function in Incremental Dialysis', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'The Effects of Low Protein Diet Supplemented With Ketoanalogues on Preservation of Residual Kidney Function Among Patients Undergoing Incremental Dialysis', 'orgStudyIdInfo': {'id': 'IRB NO.779/62'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Placebo', 'description': 'Twice weekly hemodialysis program plus regular protein diet (1.0 g/kg/day) every day'}, {'type': 'EXPERIMENTAL', 'label': 'Ketosteril', 'description': 'Incremental hemodialysis program, starting from once weekly hemodialysis/hemodialysis filtration(HDF) plus low protein diet (0.6 g/kg/day) and ketoanologues 0.12g/kg/day supplementation on non-dialysis days and regular protein diet (1.0-1.2 g/kg/day) on dialysis day', 'interventionNames': ['Drug: Ketosteril']}], 'interventions': [{'name': 'Ketosteril', 'type': 'DRUG', 'otherNames': ['incremental hemodialysis', 'low protein diet'], 'description': 'ketoanalogues of essential amino acid', 'armGroupLabels': ['Ketosteril']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Kearkiat Praditpornsilpa', 'investigatorAffiliation': 'Chulalongkorn University'}}}}