Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-03-02 @ 6:07 PM
Study NCT ID:
NCT05623033
Status:
RECRUITING
Last Update Posted:
2022-11-22
First Post:
2022-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Predictive Value of Dynamic Changes of CD4+T Lymphocytes in Primary Nephrotic Syndrome With Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009404', 'term': 'Nephrotic Syndrome'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D009401', 'term': 'Nephrosis'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 156}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-20', 'studyFirstSubmitDate': '2022-11-07', 'studyFirstSubmitQcDate': '2022-11-17', 'lastUpdatePostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dynamic changes of CD4+T cells', 'timeFrame': '3 years after the project starts', 'description': 'Whether the change of CD4+T lymphocytes count can predict infections in patients with primary nephrotic syndrome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nephrotic Syndrome', 'Infections', 'Lymphocyte']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to test whether the dynamic changes of CD4+T lymphocytes can predict infections in patients with primary nephrotic syndrome . The main questions it aims to answer are:\n\n* whether the dynamic changes of CD4+T lymphocytes can predict infections in patients with primary nephrotic syndrome\n* effect of different immunosuppressive therapy on the number and function of T lymphocyte subsets in patients with primary nephrotic syndrome\n\nParticipants will be divided into infection group and non-infection group according to whether they are infected'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with primary nephrotic syndrome', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 14 years and\\<75 years.\n2. It meets the diagnostic criteria of primary nephrotic syndrome, i.e. a. A large amount of proteinuria (24h urine protein quantity \\> 3.5g/d); b. Hypoalbuminemia (liver function: albumin\\<30g/L); c. Edema; d. The blood lipid is elevated. Among them, item a and b are necessary conditions for diagnosis.\n3. Nephrocentesis pathology indicates the pathological type of nephrotic syndrome (minimal change glomerulonephritis, membranous nephropathy, focal segmental glomerulonephritis, membranous proliferative glomerulonephritis, mesangial proliferative glomerulonephritis).\n4. Glucocorticoids or corticosteroids combined with immunosuppressants should be used clinically.\n\nExclusion Criteria:\n\n1. Secondary nephrotic syndrome, such as secondary to systemic lupus erythematosus, hepatitis B, hepatitis C, tumor, organic solvent , heavy metal poisoning, etc.\n2. Patients with tumor and chronic infectious diseases, such as HIV infection, cardiac insufficiency, acute hepatitis, transaminase increase more than twice the normal value, deep vein thrombosis.\n3. The subjects were pregnant and lactating women.\n4. Patients with serious primary diseases such as heart, brain, liver and hematopoietic system.\n5. Those who can not cooperate, such as the mentally ill.\n6. It is known that it is allergic to or has contraindications to any component in glucocorticoid, FK506, MMF and CTX.\n7. Serum creatinine (SCR) \\> 265.2 μ mol/L（3mg/dl）。'}, 'identificationModule': {'nctId': 'NCT05623033', 'briefTitle': 'The Predictive Value of Dynamic Changes of CD4+T Lymphocytes in Primary Nephrotic Syndrome With Infection', 'organization': {'class': 'OTHER', 'fullName': 'Fifth Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'The Predictive Value of Dynamic Changes of CD4+T Lymphocytes in Primary Nephrotic Syndrome With Infection', 'orgStudyIdInfo': {'id': 'WPZhu'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'infection group', 'interventionNames': ['Other: The study is an observational study without intervention']}, {'label': 'non-infection group', 'interventionNames': ['Other: The study is an observational study without intervention']}], 'interventions': [{'name': 'The study is an observational study without intervention', 'type': 'OTHER', 'description': 'The study is an observational study without intervention', 'armGroupLabels': ['infection group', 'non-infection group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '519000', 'city': 'Zhuhai', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ZHU weiping, associate chief physician', 'role': 'CONTACT', 'email': '292428893@qq.com', 'phone': '13926927805', 'phoneExt': '13926927805'}], 'facility': 'the fifth affiliated hospital of SUN YAT-SEN university', 'geoPoint': {'lat': 22.27694, 'lon': 113.56778}}], 'centralContacts': [{'name': 'Wei Ping Zhu', 'role': 'CONTACT', 'email': 'zhuwp@mail.sysu.edu.cn', 'phone': '13926927805', 'phoneExt': '0756-2528701'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fifth Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, {'name': 'Guangdong traditional Chinese medicine hospital, Zhuhai', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}