Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-26 @ 2:57 PM
Study NCT ID:
NCT01637792
Status:
COMPLETED
Last Update Posted:
2016-07-22
First Post:
2012-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D001002', 'term': 'Anuria'}, {'id': 'D010538', 'term': 'Peritonitis'}], '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'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-20', 'studyFirstSubmitDate': '2012-07-01', 'studyFirstSubmitQcDate': '2012-07-08', 'lastUpdatePostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Residual kidney function including glomerular filtration rate (GFR), daily urine voume (Uvol), and anuria-free survival.', 'timeFrame': 'Up to 24 months after CAPD initiation', 'description': 'GFR was calculated by the mean of renal clearance of urea and creatinine from a 24-h urine collection. Anuria was termed as consistently Uvol \\< 100 ml/day for more than a month.'}], 'secondaryOutcomes': [{'measure': 'Number of participants having technique failure refering to switching to maintenance hemodialyisis', 'timeFrame': 'Up to 24 months after CAPD initiation.'}, {'measure': 'Number of participants died', 'timeFrame': 'Up to 24 months after CAPD initiation'}, {'measure': 'Episodes of peritonitis', 'timeFrame': 'Up to 24 months after CAPD initiation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['peritoneal dialysis', 'dose', 'residual kidney function', 'technique survival', 'patient survival', 'peritonitis'], 'conditions': ['End Stage Renal Disease', 'Anuria', 'Peritonitis']}, 'referencesModule': {'references': [{'pmid': '8728185', 'type': 'BACKGROUND', 'citation': 'Lo WK, Jiang Y, Cheng SW, Cheng IK. Survival of CAPD patients in a center using three two-liter exchanges as standard regime. Perit Dial Int. 1996;16 Suppl 1:S163-6.'}, {'pmid': '9323505', 'type': 'BACKGROUND', 'citation': 'Szeto CC, Lai KN, Yu AW, Leung CB, Ho KK, Mak TW, Li PK, Lam CW. Dialysis adequacy of Asian patients receiving small volume continuous ambulatory peritoneal dialysis. Int J Artif Organs. 1997 Aug;20(8):428-35.'}, {'pmid': '18790809', 'type': 'BACKGROUND', 'citation': 'Fang W, Qian J, Lin A, Rowaie F, Ni Z, Yao Q, Bargman JM, Oreopoulos DG. Comparison of peritoneal dialysis practice patterns and outcomes between a Canadian and a Chinese centre. Nephrol Dial Transplant. 2008 Dec;23(12):4021-8. doi: 10.1093/ndt/gfn372. Epub 2008 Sep 12.'}, {'pmid': '11007375', 'type': 'BACKGROUND', 'citation': 'Singhal MK, Bhaskaran S, Vidgen E, Bargman JM, Vas SI, Oreopoulos DG. Rate of decline of residual renal function in patients on continuous peritoneal dialysis and factors affecting it. Perit Dial Int. 2000 Jul-Aug;20(4):429-38.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to explore the impacts of different continuous ambulatory peritoneal dialysis (CAPD) dosage (three 2-Liter exchanges CAPD vs. four 2-Liter exchanges CAPD) on residual kidney function, technique survival, patient survival, and peritonitis in incident Chinese peritoneal dialysis patients.', 'detailedDescription': '1. The primary end point for this study was changes in residual kidney function including GFR, daily urine volume (Uvol), and anuria-free survival. GFR and Uvol were evaluated within 1 week before CAPD initiation (the baseline), and then at month 1, 6, 12, 18 and 24. At the same time, body weight, blood pressure, daily net ultrafiltration, dialysis adequacy, peritoneal solute transport rate, and biochemical parameters etc. were assessed. Once an episode of peritonitis or other serious reversible intercurrent illness occurred, all the assessments were delayed one month after being cured. Anuria was termed by daily Uvol permanently less than 100 ml.\n2. The secondary end points included technique survival, patient survival and peritonitis. Technique failure was defined as switching to maintenance hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* incident CAPD patients aged 18 to 80 years\n* GFR ≥ 2 ml/min and Uvol ≥ 500 ml/day\n\nExclusion Criteria:\n\n* have a history of maintenance hemodialysis or renal transplantation\n* anticipated life expectancy less than 6 months\n* with active malignancy, acute infection, significant heart failure or in other severe conditions\n* unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT01637792', 'briefTitle': 'Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD', 'orgStudyIdInfo': {'id': '044119620'}, 'secondaryIdInfos': [{'id': '07QA14040', 'type': 'OTHER_GRANT', 'domain': 'Science and Technology Commission of Shanghai Municipality'}, {'id': '08DZ1900501', 'type': 'OTHER_GRANT', 'domain': 'Science and Technology Commission of Shanghai Municipality'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Three 2-liter exchanges group', 'description': 'A group of randomly assigned patients undergoing three 2-liter exchanges daily CAPD.', 'interventionNames': ['Other: Three 2-liter exchanges daily CAPD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Four 2-liter exchanges group', 'description': 'A group of randomly assigned patients undergoing four 2-liter exchanges daily CAPD.', 'interventionNames': ['Other: Four 2-liter exchanges daily CAPD']}], 'interventions': [{'name': 'Three 2-liter exchanges daily CAPD', 'type': 'OTHER', 'otherNames': ['small volume CAPD'], 'description': 'CAPD regimen of three 2-liter daily exchanges', 'armGroupLabels': ['Three 2-liter exchanges group']}, {'name': 'Four 2-liter exchanges daily CAPD', 'type': 'OTHER', 'otherNames': ['standard volume CAPD'], 'description': 'CAPD regimen of four 2-liter daily exchagnes', 'armGroupLabels': ['Four 2-liter exchanges group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji Hospital, Shanghai Jiao Tong University school of medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Wei Fang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renal Division, Renji Hospital, Shanghai Jiaotong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Aiwu Lin', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}