Ignite Creation Date:
2025-12-24 @ 6:46 PM
Ignite Modification Date:
2025-12-28 @ 10:36 AM
Study NCT ID:
NCT01779557
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2013-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness Evaluation of Two Kinds of Peritoneal Dialysate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2013-01-29', 'studyFirstSubmitQcDate': '2013-01-29', 'lastUpdatePostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'AE, vital signs, laboratory tests', 'timeFrame': '1,2,3,4,5 years'}, {'measure': 'peritonitis', 'timeFrame': '1,2,3,4,5 years'}, {'measure': 'quality of products', 'timeFrame': '1,2,3,4,5 years'}, {'measure': 'allergy to PD fluids, bags and tubes', 'timeFrame': '1,2,3,4,5 years'}], 'primaryOutcomes': [{'measure': 'survival rate', 'timeFrame': '1,2,3,4,5 years'}], 'secondaryOutcomes': [{'measure': 'PD technique survival rate', 'timeFrame': '1,2,3,4,5 years'}, {'measure': 'estimated glomerular filtration rate decline', 'timeFrame': '1,2,3,4,5 years'}, {'measure': 'nutritional status', 'timeFrame': '1,2,3,4,5 years'}, {'measure': 'quality of life(SF-36)', 'timeFrame': '1,2,3,4,5 years'}, {'measure': 'cardiovascular events', 'timeFrame': '1,2,3,4,5 years'}, {'measure': 'increments of dialysis dose', 'timeFrame': '1,2,3,4,5 years'}, {'measure': 'medical costs', 'timeFrame': '1,2,3,4,5 years'}, {'measure': 'dropout rate', 'timeFrame': '1,2,3,4,5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CAPD', 'efficacy', 'safety', 'survival rate'], 'conditions': ['Kidney Failure,Chronic']}, 'referencesModule': {'references': [{'pmid': '26715594', 'type': 'DERIVED', 'citation': 'Zhou J, Cao X, Lin H, Ni Z, He Y, Chen M, Zheng H, Chen X. Safety and effectiveness evaluation of a domestic peritoneal dialysis fluid packed in non-PVC bags: study protocol for a randomized controlled trial. Trials. 2015 Dec 29;16:592. doi: 10.1186/s13063-015-1131-1.'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the effectiveness and safety of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate, investigate the proper dialysis dose for Chinese CAPD patients.', 'detailedDescription': 'This study is a prospective, randomized, parallel, controlled, multi-center clinical study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate.It aims to investigate the proper dialysis dose for Chinese CAPD patients.At the same time,it can evaluate the effectiveness and safety of Chinese product Huaren Peritoneal Dialysate and peritoneal dialysis product Baxter Peritoneal Dialysate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18, male or female\n* Patients with end stage renal diseases\n* Dialysis mode: CAPD\n* Dialysis duration:≥30 days and ≤6 months\n* Be capable of implementing home dialysis\n* Diabetic nephropathy, 3ml/min≤ residual renal GFR ≤15ml/min; other renal diseases, 3ml/min≤ residual renal GFR ≤10ml/min\n* Sign the written informed consent\n\nExclusion Criteria:\n\n* Acute renal failure\n* Planing to receive kidney transplantation in 2 years\n* Hemodialysis\n* Exit site infection or tunnel infection\n* Presenting 2/3 of the following: a. abdominal pain, turbid ascites, with or without fever; b. drainage fluid WBC\\>100×106/L, neutrophil ratio\\>50%; c.culture positive/ Gram stain positive in drainage fluid;\n* Anti-HIV positive\n* Allergic to components of dialysate\n* Active, residual malignant tumor, or systemic infection, liver cirrhosis, severe congestive heart failure, anemia（Hb\\<80g/L）,malnutrition（Serum Alb\\<28g/L）,refractory hypertension\n* Identified peritoneal high transportation by peritoneal equilibration test (PET)\n* Extreme body shape (height\\> 185cm or height \\<145cm), obesity (BMI ≥ 33kg/m2)\n* Poor compliance\n* Pregnant or lactating, women of childbearing age do not agree to use effective contraceptive measures during the trial\n* Has a history of alcoholism and drug abuse (defined as illegal drugs)\n* Any circumstances when patients are believed unsuitable for this trial'}, 'identificationModule': {'nctId': 'NCT01779557', 'acronym': 'SEED', 'briefTitle': 'Safety and Effectiveness Evaluation of Two Kinds of Peritoneal Dialysate', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'The Prospective, Randomized, Parallel, Controlled, Multi-center Clinical Study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate', 'orgStudyIdInfo': {'id': 'HR-PD-2012'}, 'secondaryIdInfos': [{'id': 'ChiCTR-TRC-13003001', 'type': 'REGISTRY', 'domain': 'Chinese Clinial Trial Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Huaren peritoneal dialysate', 'description': 'Huaren Peritoneal dialysate CAPD 3-5 times/d', 'interventionNames': ['Drug: Huaren Peritoneal Dialysate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Baxter Peritoneal Dialysate', 'description': 'Baxter Peritoneal dialysate CAPD 3-5 times/d', 'interventionNames': ['Drug: Baxter Peritoneal Dialysate']}], 'interventions': [{'name': 'Huaren Peritoneal Dialysate', 'type': 'DRUG', 'description': 'Huaren Peritoneal dialysate CAPD 3-5 times/d', 'armGroupLabels': ['Huaren peritoneal dialysate']}, {'name': 'Baxter Peritoneal Dialysate', 'type': 'DRUG', 'description': 'Baxter Peritoneal dialysate CAPD 3-5 times/d', 'armGroupLabels': ['Baxter Peritoneal Dialysate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'CHEN Xiangmei, yes', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Chief physician, Academician of Chinese Academy of Engineering', 'investigatorFullName': 'Chen Xiangmei', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}