Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 10:38 AM
Study NCT ID:
NCT05158959
Status:
UNKNOWN
Last Update Posted:
2021-12-15
First Post:
2021-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Renal Reserve Function and Progression of Renal Function to Predict CKD Risk in Thai Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-02', 'studyFirstSubmitDate': '2021-12-02', 'studyFirstSubmitQcDate': '2021-12-02', 'lastUpdatePostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of renal functional reserve per 12 months (mL/min)', 'timeFrame': '12 months', 'description': 'Renal functional reserve defined as the difference between baseline creatinine clearance and creatinine clearance achieved under stimulation with amino acid infusion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Renal functional reserve, CKD progression, Elderly'], 'conditions': ['Elder', 'Renal Function Abnormal']}, 'descriptionModule': {'briefSummary': 'This study investigates renal functional reserve in elderly.', 'detailedDescription': 'The prevalence of CKD in elder is high as age has been a variable in eGFR equation. eGFR by calculation always declines in parallel with age. The assumption that a persistent over 3 months of eGFR less than 60 mL/min/1.73m2 define CKD with risk of progression and need refer to nephrologist may not necessary true in aging population. We study renal functional reserve in elderly population who risk of CKD progression and ESRD is the highest prevalence in human life cycle and explore whether renal functional reserve can be used as ad additional marker of CKD progression in elderly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Elders age more than 60 years who are non-frail and has no limited life expectancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age \\> 60 years at screening\n* Patient willing to participate in the study and can provide inform consent\n* Patient have residual kidney function ≤ 90 ml/min/1.73m2 by CKD-EPI equation\n\nExclusion Criteria:\n\n* Patient active smoking\n* Patient have Charlson comorbidity index \\> .....\n* Patient active cancer\n* Patient contraindications for blood collection\n* Patients with a history of hypersensitivity to cimetidine or amino acid IV solution'}, 'identificationModule': {'nctId': 'NCT05158959', 'briefTitle': 'Association Between Renal Reserve Function and Progression of Renal Function to Predict CKD Risk in Thai Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Study of the Association Between Renal Reserve Function and Progression of Renal Function to Predict Chronic Kidney Disease Risk in Thai Elderly', 'orgStudyIdInfo': {'id': 'IRB NO.527/62'}}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Kearkiat Praditpornsilpa, MD', 'role': 'CONTACT', 'email': 'kearkiat@hotmail.com', 'phone': '6602564251'}], 'facility': 'Kearkiat Praditpornsilpa', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Kearkiat Praditpornsilpa', 'investigatorAffiliation': 'Chulalongkorn University'}}}}