Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-01-02 @ 5:21 AM
Study NCT ID:
NCT06441435
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of AC-134 in Chronic Kidney Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D000881', 'term': 'Anthrax'}], 'ancestors': [{'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': 'D016863', 'term': 'Bacillaceae Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-28', 'studyFirstSubmitDate': '2024-05-21', 'studyFirstSubmitQcDate': '2024-05-28', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated glomerular filtration rate (eGFR) measurement', 'timeFrame': 'Baseline to 3 months', 'description': 'The eGFR level is a maker for kidney function'}, {'measure': 'Blood Urea Nitrogen (BUN) levels', 'timeFrame': 'Baseline to 3 months', 'description': 'Blood Urea Nitrogen'}, {'measure': 'Uremic toxins assay', 'timeFrame': 'Baseline to 3 months', 'description': "The concentration of p-cresol sulfate level, indoxyl sulfates level, and acrolein in the subjects' blood samples"}], 'secondaryOutcomes': [{'measure': 'Liver function', 'timeFrame': 'Baseline to 3 months', 'description': "The concentration of ALT, AST, total bilirubin and direct bilirubin in the subjects' blood samples"}, {'measure': 'Inflammation makers', 'timeFrame': 'Baseline to 3 months', 'description': "The concentration of inflammation makers in the subjects' blood samples"}, {'measure': 'Nutrition status', 'timeFrame': 'Baseline to 3 months', 'description': "The concentration of albumin, wbc and uric acid in the subjects' blood samples"}, {'measure': 'Lipid analysis', 'timeFrame': 'Baseline to 3 months', 'description': "The concentration of total cholesterol , triglyceride , HDL-cholesterol and LDL-cholesterol in the subjects' blood samples"}, {'measure': 'Sugar test', 'timeFrame': 'Baseline to 3 months', 'description': "The concentration of fasting sugar and HbA1C in the subjects' blood samples"}, {'measure': 'The quality of life', 'timeFrame': 'Baseline to 3 months', 'description': 'It will measure by the Kidney Disease Quality of Life (\\[KDQOL\\]-SF™) questionnaire'}, {'measure': 'Anemia test', 'timeFrame': 'Baseline to 3 months', 'description': "The concentration of hemoglobin (Hb) in the subject's blood samples"}, {'measure': 'Urine protein analysis', 'timeFrame': 'Baseline to 3 months', 'description': 'Urine specimen collection will be evaluated on the spot and 24-hour urine protein'}, {'measure': '24-hour Dietary recall', 'timeFrame': 'Baseline to 3 months', 'description': 'There will be collected by food models or a photography atlas to estimate portion size'}, {'measure': 'Gastrointestinal symptoms measures', 'timeFrame': 'Baseline to 3 months', 'description': 'There will be collected by questionnaires symptoms or chief complaints'}, {'measure': 'Grip strength levels', 'timeFrame': 'Baseline to 3 months', 'description': 'Hand grip strength was measured by grip strength device'}, {'measure': 'Blood gas', 'timeFrame': 'Baseline to 3 months', 'description': "The concentration of blood gas test in the subject's blood samples"}, {'measure': 'Electrolytes Analysis', 'timeFrame': 'Baseline to 3 months', 'description': "The concentration of electrolytes analysis in the subject's blood samples"}, {'measure': 'Mitochondrial oxidative stress', 'timeFrame': 'Baseline to 3 months', 'description': "The concentration analysis in the subject's blood or urine samples, such as MDA"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Kidney Diseases', 'Activated charcoal'], 'conditions': ['Nephrology']}, 'descriptionModule': {'briefSummary': 'The objective is to explore the effects of adding AC-134 on renal function, proteinuria, uremic toxins, and metabolism-related markers in chronic kidney disease.', 'detailedDescription': 'Chronic kidney disease (CKD) management primarily focuses on addressing associated complications such as hypertension, diabetes mellitus, cardiovascular disease, and proteinuria. In addition to standard therapies, reducing the accumulation of toxins, particularly gut-derived uremic toxins like indoxyl sulfate (IS) and p-cresol sulfate (PCS), may help alleviate uremia symptoms. This study assesses the impact of oral AC-134 capsules containing activated charcoal adsorbent on CKD patients. The assessment will include evaluating changes in renal function, proteinuria, uremic toxins, and metabolism-related markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 20-90 years.\n* Diagnosed with stage 3-5 chronic kidney disease, excluding dialysis patients.\n* Signed informed consent is required before enrollment.\n\nExclusion Criteria:\n\n* Use of other brand-activated charcoal supplements during the study period.\n* Pregnant or lactating women.\n* Patients who have undergone kidney transplantation.\n* Obstructive nephropathy within the past month.\n* Acute kidney injury within the past three months.\n* Gastrointestinal bleeding or severe constipation within the past three months.\n* Patients with active malignancy within the past two years.\n* Severe cardiovascular diseases such as congestive heart failure New York class III-IV or cerebrovascular disease\n* Severe liver disease, such as liver cirrhosis with ascites.\n* Active infectious disease'}, 'identificationModule': {'nctId': 'NCT06441435', 'briefTitle': 'The Effect of AC-134 in Chronic Kidney Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'To Investigate the Protective Effect of AC 134 in Chronic Kidney Diseases.', 'orgStudyIdInfo': {'id': 'SF23520C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Low-protein diet strategies combined with AC-134 capsules', 'interventionNames': ['Dietary Supplement: Low protein diet with AC-134']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Low-protein diet strategies', 'interventionNames': ['Other: Standard treatment']}], 'interventions': [{'name': 'Low protein diet with AC-134', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Low protein diet combined with AC-134 Dosage: 2 capsules,three times/day', 'armGroupLabels': ['Intervention group']}, {'name': 'Standard treatment', 'type': 'OTHER', 'description': 'Low protein diet', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40705', 'city': 'Taichung', 'state': 'ROC', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Wen-Ching Yang', 'role': 'CONTACT', 'email': 'nutri1234@vghtc.gov.tw', 'phone': '(04)23592525', 'phoneExt': '2626'}], 'overallOfficials': [{'name': 'Cheng-Hsu Chen, MDPHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Nephrology in Taichung Veterans General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'All Clean Health Co., Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}