Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2026-01-03 @ 7:59 PM
Study NCT ID:
NCT02393261
Status:
UNKNOWN
Last Update Posted:
2015-03-19
First Post:
2015-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Controlled and Multi-Center Study of 2500ml Huaren Peritoneal Dialysate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015314', 'term': 'Dialysis Solutions'}], 'ancestors': [{'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-18', 'studyFirstSubmitDate': '2015-03-09', 'studyFirstSubmitQcDate': '2015-03-18', 'lastUpdatePostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adequacy of dialysis (kt/v)', 'timeFrame': 'up to 8 weeks', 'description': 'kt/v'}], 'secondaryOutcomes': [{'measure': 'Residual kidney function (Residual kidney kt/v)', 'timeFrame': 'up to 6 months', 'description': 'Residual kidney kt/v'}, {'measure': 'Peritoneal function (Peritoneal equilibration test)', 'timeFrame': 'up to 6 months', 'description': 'Peritoneal equilibration test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Disorders Associated With Peritoneal Dialysis']}, 'descriptionModule': {'briefSummary': 'This prospective, randomized, controlled, multi-center clinical trial will evaluate the validity and security of 2500ml Huaren Peritoneal Dialysate compared with normal 2000ml peritoneal dialysate.', 'detailedDescription': 'Peritoneal dialysis (PD) is one of important way of renal replacement treatment worldwide. In China, about 40,000 patients suffered from end stage renal disease treated with PD, and most of them used imported dialysate, of which the price carried a great burden. Now, cheaper domestic dialysate is accessed to the ESRD patients in china, but the efficacy and safety of which are not fully clear. And according to researches from Hongkong, 6000ml of dialysate every day is able to. Thus, we presume 3 bags of 2500ml Huaren dialysate will satisfy the everyday need of an normal Asian. This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night, while those in control group will use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night for 12 weeks. After followed-up for 12 weeks, the adequacy of PD, residual kidney function , peritoneum function and QOL of patients will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. The duration of PD is more than 1 month.\n2. The age is range from 18 to 80 years old.\n3. The patient can be treated with regular PD in home.\n4. The volume of peritoneal dialysate is from 8L to 10 L in 1 day.\n5. The patient can be visited regularly.\n6. The patient must be freely given informed consent\n\nExclusion criteria:\n\n1. Peritonitis was happened within 1 month\n2. The KT/V\\<1.7\n3. Infections in the exit or tunnel\n4. With tumors.\n5. With low transport of peritoneum.\n6. With mental and behavior disorders.\n7. With acute renal failure\n8. Hemodialysis meanwhile\n9. With heart failure( NYHA III-IV ) or cardio- cerebrovascular events\n10. Attending other clinical trails\n11. Refused to give informed consent Exit criteria\n\n（1）Stop PD for more than 10 days （2）The patient demand to quit from the RCT （3）With serious adverse events.'}, 'identificationModule': {'nctId': 'NCT02393261', 'briefTitle': 'A Controlled and Multi-Center Study of 2500ml Huaren Peritoneal Dialysate', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Validity and Security of 2500ml Huaren Peritoneal Dialysate: A Prospective, Randomized, Controlled, Multi-Center Clinical Trial', 'orgStudyIdInfo': {'id': 'Usix -2500PD-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A 2500mlGroup', 'description': 'use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night', 'interventionNames': ['Other: 2500ml Huaren peritoneal dialysate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B 2000mlGroup', 'description': 'use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night', 'interventionNames': ['Other: 2000ml peritoneal dialysate']}], 'interventions': [{'name': '2500ml Huaren peritoneal dialysate', 'type': 'OTHER', 'description': 'use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night', 'armGroupLabels': ['A 2500mlGroup']}, {'name': '2000ml peritoneal dialysate', 'type': 'OTHER', 'description': 'use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night', 'armGroupLabels': ['B 2000mlGroup']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510655', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zongpei Jiang, M.D. & Ph.D.', 'role': 'CONTACT', 'email': 'jx.home@medmail.com.cn', 'phone': '8620-38379727'}, {'name': 'Zongpei Jiang, M.D. & Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Zongpei Jiang, M.D. & Ph.D.', 'role': 'CONTACT', 'email': 'jx.home@medmail.com.cn', 'phone': '8620-38379727'}], 'overallOfficials': [{'name': 'Zongpei Jiang, M.D. & Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Sixth Affiliated Hospital, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The Sixth Affiliated Hospital of Sun Yat-Sen University', 'investigatorFullName': 'Yanhong Deng', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}