Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT06358820
Status:
COMPLETED
Last Update Posted:
2025-07-16
First Post:
2024-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': '276531255@qq.com', 'phone': '13927596600', 'title': 'Shanshan Deng', 'organization': "Gaozhou People's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From the beginning to the end of the study, the time span is from December 2023 to January 2025.Follow up with each subject for 6 months and record adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Adverse Event', 'description': 'Adverse Event (AE) refers to any harmful medical event that occurs during a clinical trial, regardless of whether it is causally related to the investigational drug. Adverse events include the following situations:\n\nAdverse Reaction (AR) related to the investigational drug: refers to any harmful medical event caused by the pharmacological effects or other reasons of the investigational drug under normal usage conditions.\n\nAdverse events unrelated to the investigational drug: Refers to any harmful medical event that occurs during a clinical trial, but is scientifically determined to have no causal relationship with the investigational drug.\n\nSerious Adverse Event (SAE): refers to any harmful medical event that occurs during a clinical trial, regardless of whether it is causally related to the investigational drug, resulting in one of the following consequences:\n\nCausing death; Endangering life (i.e., if not intervened in a timely manner, it may lead to death); Need for hospitalization or extended hospitalization; Causing persistent or significant disability or functional impairment; Causing congenital malformations or birth defects; Significant medical interventions (such as surgery, blood transfusions, etc.) are required.', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 3, 'seriousNumAtRisk': 149, 'deathsNumAffected': 1, 'seriousNumAffected': 31}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic foot infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory system infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal lesions and fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subcutaneous tunnel infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Displacement of peritoneal dialysis catheter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0.67'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Blood Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self Control', 'description': 'Compare the nutritional and safety indicators of the subjects before treatment and during the third and sixth months of treatment.\n\nAmino acid peritoneal dialysis solution: Each subject received treatment with 1 bag of amino acid peritoneal dialysis daily and 2-4 bags of glucose peritoneal dialysis solution daily for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '4.02', 'spread': '3.64', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0125', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.77', 'ciLowerLimit': '3.15', 'ciUpperLimit': '4.39', 'pValueComment': 'A 2-sided P value less than 0.05 was considered statistically significant. However, the significance level (α) was adjusted to 0.0125 to account for multiple testing.', 'estimateComment': 'The main analysis was based on LOCF for missing value.', 'groupDescription': 'Outcome Measure were assessed at baseline and every month during the 6-month study.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': '\\>0.15 g/dL change in albumin from baseline to month 6 was anticipated.'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Changes in blood albumin levels', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All included subjects received at least 1 dose of study treatment and had data for efficacy evaluation at at least 1 post-treatment observation time point.'}, {'type': 'PRIMARY', 'title': 'Prealbumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self Control', 'description': 'Compare the nutritional and safety indicators of the subjects before treatment and during the third and sixth months of treatment.\n\nAmino acid peritoneal dialysis solution: Each subject received treatment with 1 bag of amino acid peritoneal dialysis daily and 2-4 bags of glucose peritoneal dialysis solution daily for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '44.23', 'spread': '81.77', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0125', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.77', 'ciLowerLimit': '26.66', 'ciUpperLimit': '56.87', 'pValueComment': 'A 2-sided P value less than 0.05 was considered statistically significant. However, the significance level (α) was adjusted to 0.0125 to account for multiple testing.', 'estimateComment': 'The main analysis was based on LOCF for missing value.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': '\\>60 mg/L change in prealbumin from baseline to month 6.'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Changes in blood prealbumin levels', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All included subjects received at least 1 dose of study treatment and had data for efficacy evaluation at at least 1 post-treatment observation time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Self Control', 'description': 'Compare the nutritional and safety indicators of the subjects before treatment and during the third and sixth months of treatment.\n\nAmino acid peritoneal dialysis solution: Each subject received treatment with 1 bag of amino acid peritoneal dialysis daily and 2-4 bags of glucose peritoneal dialysis solution daily for 6 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'A total of 150 cases signed informed consent forms to participate in the clinical study, with 1 screening failure, resulting in 149 cases entering the clinical research.', 'groupId': 'FG000', 'numSubjects': '149'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'A total of 142 patients (95.3%) had at least one efficacy assessment.The withdrawal reasons included PD-related condition deterioration requiring treatment (n = 1, 4.76%), kidney transplantation (n = 3, 14.29%) , patient non-compliance with study protocol, serious adverse events (n = 11, 52.38%) and patient voluntary withdrawal (n = 6, 28.57%)', 'groupId': 'FG000', 'numSubjects': '128'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'kidney transplantation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'patient voluntary withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Enrolled', 'description': 'Patients who completed one efficacy evaluation were defined as having completed the study.149 patients were enrolled, with 142 patients undergoing at least one efficacy evaluation.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'spread': '10.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'title': '149', 'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '149', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of CAPD（Continuous ambulatory peritoneal dialysis）', 'classes': [{'categories': [{'measurements': [{'value': '2.67', 'spread': '1.16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Residual urine', 'classes': [{'categories': [{'measurements': [{'value': '300', 'groupId': 'BG000', 'lowerLimit': '50', 'upperLimit': '650'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ml/day', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-30', 'size': 484711, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-13T22:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2024-04-07', 'resultsFirstSubmitDate': '2025-06-01', 'studyFirstSubmitQcDate': '2024-04-07', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-27', 'studyFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Albumin', 'timeFrame': '6 months', 'description': 'Changes in blood albumin levels'}, {'measure': 'Prealbumin', 'timeFrame': '6 months', 'description': 'Changes in blood prealbumin levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['amino acid peritoneal dialysis solution；peritoneal dialysis'], 'conditions': ['Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution']}, 'referencesModule': {'references': [{'pmid': '40864356', 'type': 'DERIVED', 'citation': 'Deng S, Xuan H, Chen L, Su X, Su Y, Lu Y, Zhu M, Yang X, Luo C, Shi W. Overnight-dwelled amino acid-based peritoneal dialysis solutions for malnutrition in CAPD: a prospective real-world study. Int Urol Nephrol. 2025 Aug 27. doi: 10.1007/s11255-025-04749-y. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This study adopts a multicenter, open, prospective, and self controlled study design, in which each participant serves as their own control before and after receiving amino acid peritoneal dialysis solution treatment to compare changes in their nutritional status. Each subject received treatment with 1 bag of amino acid peritoneal dialysis per day and 2-4 bags of glucose peritoneal dialysis solution per day for 6 months (the amount of glucose peritoneal dialysis solution used was determined based on the treatment plan selected by the patient during the screening period when they entered the study).Before treatment and during the 3rd and 6th months of treatment, subjects were evaluated for various efficacy and safety indicators, and any adverse or serious adverse events were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. For uremic patients with malnutrition during the screening period, maintenance peritoneal dialysis should be performed for at least 3 months. The standard for malnutrition should meet at least two of the following items: (1) serum albumin level\\<3.5g/dL (35g/L), (2) prealbumin\\<300mg/L, (3) modifiedSubjective Global Assessment (SGA) with a score of\\>7;\n2. Blood urea nitrogen ≤ 38mmol/L;\n3. The patient's age is between 18 and 75 years old;\n4. The patient signs an informed consent form.\n\nExclusion Criteria:\n\n1. Individuals who are allergic to any amino acids or excipients in this product\n2. More than one occurrence of peritonitis in the past three months; Peritonitis or hospitalization within the past month;\n3. Patients with hyperthyroidism, systemic infection, fever, and other high catabolic metabolic diseases, as well as those who are taking drugs that affect tissue metabolism, such as corticosteroids;\n4. Congenital amino acid metabolism deficiency disease, acute severe pancreatitis, severe hyperbilirubinemia 5. Patients with malignant tumor metastasis or spread, residual cancer after treatment, coagulation dysfunction, aplastic anemia, heart, brain, lung and other serious system diseases;\n\n6\\. Possible kidney transplantation during the trial period; 7. Active phase of hepatitis B or C, liver cirrhosis, active liver disease, liver dysfunction, or positive serum reaction of human immunodeficiency virus (HIV); 8. Those who have participated in clinical trials of other drugs within the three months prior to enrollment; 9. Pregnant and lactating women; 10. Those who are mentally unable to cooperate; 11. Failure to sign a written informed consent form; 12. Unable or unwilling to comply with the experimental protocol approved by the researcher."}, 'identificationModule': {'nctId': 'NCT06358820', 'briefTitle': 'Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution', 'organization': {'class': 'OTHER', 'fullName': "The People's Hospital of Gaozhou"}, 'officialTitle': 'Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution in Improving Nutritional Status in Maintenance Peritoneal Dialysis Patients: a Multicenter, Open, Prospective, Self Controlled Clinical Study', 'orgStudyIdInfo': {'id': 'PHGaozhou'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Self Control', 'description': 'Compare the nutritional and safety indicators of the subjects before treatment and during the third and sixth months of treatment.', 'interventionNames': ['Drug: Amino acid peritoneal dialysis solution']}], 'interventions': [{'name': 'Amino acid peritoneal dialysis solution', 'type': 'DRUG', 'description': 'Each subject received treatment with 1 bag of amino acid peritoneal dialysis daily and 2-4 bags of glucose peritoneal dialysis solution daily for 6 months', 'armGroupLabels': ['Self Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '525200', 'city': 'Gaozhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Gaozhou People's Hospital", 'geoPoint': {'lat': 21.91965, 'lon': 110.85678}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "The People's Hospital of Gaozhou", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'deng shanshan', 'investigatorAffiliation': "The People's Hospital of Gaozhou"}}}}