Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT05353660
Status:
RECRUITING
Last Update Posted:
2025-06-15
First Post:
2022-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Kidney Disease-related Sarcopenia With Poor Prognosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'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': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2022-04-25', 'studyFirstSubmitQcDate': '2022-04-25', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sarcopenia', 'timeFrame': '1 year', 'description': 'The sarcopenia is defined as: Patients with low strength: handgrip \\<28kg for male or \\<18kg for female; Or low muscle mass: appendicular skeletal muscle mass/height2 \\<7kg/m2 for male or \\<5.7kg/m2 for female; Or low performance: 6-metre walk: \\<1.0 m/s or 5-time chair stand test: ≥12 s'}, {'measure': 'The progression of chronic kidney diseases in CKD patients', 'timeFrame': '1 year', 'description': 'The progression of chronic kidney disease is defined as: Patients had a 50% or greater decrease in baseline eGFR \\<60 ml /min/1.73m2; Or end-stage renal disease (eGFR \\<15 ml /min/1.73m2, or initiation of renal replacement therapy)'}, {'measure': 'All-cause mortality in maintenance hemodialysis patients', 'timeFrame': '1 year', 'description': 'All-cause mortality is defined as the death due to any reasons.'}], 'secondaryOutcomes': [{'measure': 'CVD mortality', 'timeFrame': '1 year', 'description': 'CVD mortality included cerebrovascular accidents, heart failure, myocardial infarction, cardiac arrest, death caused by malignant arrhythmias, and sudden death.'}, {'measure': 'cardiovascular events', 'timeFrame': '1 year', 'description': 'Cardiovascular events included stroke, myocardial infarction, angina, congestive heart failure and other cardiovascular events.'}, {'measure': 'Rate of participants with hospitalization.', 'timeFrame': '1 year', 'description': 'Hospitalization for any reason'}, {'measure': 'Rate of participants with fall.', 'timeFrame': '1 year', 'description': 'Rate of participants with fall.'}, {'measure': 'Rate of participants with bone fracture.', 'timeFrame': '1 year', 'description': 'Rate of participants with bone fracture.'}, {'measure': 'Change of quality of life', 'timeFrame': '1 year', 'description': 'The quality of life is assessd by 12-item Short-Form Health Survey Questionnaire (SF-12) Survey Questionnaire (SF-12)'}, {'measure': 'Frailty', 'timeFrame': '1 year', 'description': 'Frailty is assessed by The FRAIL Scale. The FRAIL Scale consists of five items: fatigue, resistance, ambulation, illness, and loss of weight. The scores range from 0 to 5,with 3 to 5 as frail, 1 to 2 as pre-frail, and 0 as normal.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Diseases', 'Sarcopenia']}, 'descriptionModule': {'briefSummary': 'Chronic kidney disease (CKD) has become a global public health priority over the past few decades, affecting 10-12% of the adult population and has received increasing attention. Sarcopenia describes a generalizes degenerative skeletal muscle disorder involving the loss of muscle mass, muscle function and/or physical performance. Indeed, Sarcopenia is a condition with many causes and it can be considered "primary sarcopenia" when no other cause is evident but ageing. While in the clinical practice, it also occurs in patients with chronic diseases, such as chronic kidney disease, which can be considered "secondary sarcopenia". Notably, the occurrence of sarcopenia in CKD patients is not only related with ageing, the accumulation of uremic toxins, inflammation, insulin resistance, malnutrition and oxidative stress also contribute to the muscle depletion. Moreover, sarcopenia increased risk of falls and fractures, impaired ability to perform activities of daily living, disabilities, loss of independence and increased risk of death. Hence, it is of great significance to prevent the occurrence and development of sarcopenia in patients with CKD. The purposes of this project were to investigate the prevalence of sarcopenia, further explore the risk factors for sarcopenia and detect the relationship between sarcopenia and outcomes in CKD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participants will be recruited from department of Nephrology, Nanfang Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1.aged ≥18 years and \\<80 years 2.eGFR\\<60ml/min/1.73m2 or had received maintenance dialysis for at least 3 months.\n\nExclusion Criteria:\n\n* 1.Patients with neuromuscular diseases: such as muscular dystrophy, amyotrophic lateral sclerosis, spinal cord injury, stroke, and myasthenia gravis; 2.Patients with neurodegenerative diseases: such as Alzheimer's disease, Parkinson's disease and Huntington's disease; 3.patients with advanced malignant tumors; 4.Patients with acute infectious diseases in the past 3 months; 5. Patients with serious cardiovascular or cerebrovascular disease; 6.Moderate to severe edema; 7.Patients with rheumatoid arthritis, multiple sclerosis, or acute gout that limit joint mobility; 8.Pregnant ; 9.Patients identified to be unsuitable for enrollment by the study physician"}, 'identificationModule': {'nctId': 'NCT05353660', 'briefTitle': 'Chronic Kidney Disease-related Sarcopenia With Poor Prognosis', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Risk Factors of Chronic Kidney Disease-related Sarcopenia and Its Relationship With Poor Prognosis', 'orgStudyIdInfo': {'id': 'NFEC-2022-122'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic kidney disease', 'interventionNames': ['Other: No intervention']}, {'label': 'maintenance hemodialysis', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['chronic kidney disease', 'maintenance hemodialysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Liang, MD', 'role': 'CONTACT', 'email': 'nyyylm@163.com', 'phone': '+86-20-61686217'}, {'name': 'Yaya Yang', 'role': 'CONTACT', 'email': 'yangyy0951@163.com', 'phone': '+86-20-62786327'}], 'facility': 'Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Min Liang, MD', 'role': 'CONTACT', 'email': 'nfyylm@163.com', 'phone': '+86-20-61686217'}, {'name': 'Yaya Yang', 'role': 'CONTACT', 'email': 'yangyy0951@163.com', 'phone': '+86-20-62786327'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will be available from the corresponding author upon request, after the request is submitted and formally reviewed and approved by the Ethics Committee of Nanfang Hospital.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}