Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-28 @ 11:14 AM
Study NCT ID:
NCT05224466
Status:
UNKNOWN
Last Update Posted:
2022-02-04
First Post:
2021-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characteristics and Clinical Outcomes of Peritoneal Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-03', 'studyFirstSubmitDate': '2021-12-14', 'studyFirstSubmitQcDate': '2022-02-03', 'lastUpdatePostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'baseline clinical characteristics before PD', 'timeFrame': 'within one month before the start of PD', 'description': 'clinical characteristics about age,sex,comorbidities before PD,laboratory data would be aggregated from the existing record to find out the differences between the long-term PD patients and the others that may affect their clinical outcome.'}], 'secondaryOutcomes': [{'measure': 'the factors that may lead to the termination of PD', 'timeFrame': 'up to 20 years', 'description': 'Some patients may end the PD early ,some late due to many reasons.To find out the factors that may influence survival rate of peritoneal dialysis technology at different time stages of peritoneal dialysis treatment, the investigators collect and record the reasons for termination of PD to analyze.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peritoneal Dialysis Complication']}, 'descriptionModule': {'briefSummary': 'Peritoneal dialysis patients worldwide account for about 11% of the global dialysis population. The global annual growth rate of peritoneal dialysis is estimated to be 8%, which is listed as the preferred method of renal replacement therapy in most countries. Although peritoneal dialysis has been widely used, due to complications such as peritoneal dialysis related infection, peritoneal ultrafiltration failure and EPS, the failure rate of peritoneal dialysis technology is high, and the 3-year technical survival rate is only 64%. Therefore, this study intends to explore clinical strategies for maintaining the long-term peritoneal dialysis by analyzing the clinical characteristics of patients , as well as the differences of risk factors affecting the survival rate of peritoneal dialysis technology at different time stages of peritoneal dialysis treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ESRD patients who start the PD at the first time', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ESRD patients\n* The first time of peritoneal dialysis\n\nExclusion Criteria:\n\n* Age \\<18 years at start of PD\n* Transfer or follow-up loss\n* Previous transplantation or HD history\n* Incomplete clinical data'}, 'identificationModule': {'nctId': 'NCT05224466', 'briefTitle': 'Characteristics and Clinical Outcomes of Peritoneal Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Characteristics and Clinical Outcomes of Peritoneal Dialysis Patients', 'orgStudyIdInfo': {'id': 'PD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'defined as patients survived on PD for more than 10 years'}, {'label': 'B', 'description': 'defined as patients survived on PD for 5-10 years'}, {'label': 'C', 'description': 'defined as patients survived on PD within 5 years'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200001', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Na Jiang, MD', 'role': 'CONTACT', 'email': 'Jiangjiang198311@163.com', 'phone': '+86-21-53882014'}], 'overallOfficials': [{'name': 'Wei Fang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'RenJi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Chief Physician of Nephrology', 'investigatorFullName': 'Na Jiang', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}