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임상시험 NCT07494526은(는) Chronic Kidney Diease, 당뇨병, 고혈압, 고지혈증, 고요산혈증에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
Chronic Kidney Disease and Metabolic Disorders in the Elderly 100,000 고령자 관찰 연구
The main questions it aims to answer are:
Do metabolic diseases (diabetes, hypertension, hyperlipidemia, hype...
더 보기Research on the Prevention, Control, and Intelligent Management Decision-Making for Comorbidities of Chronic Kidney Disease and Metabolic Disorders in the Elderly
- 2024YFC3607400
- 2024YFC3607400 (기타 보조금/자금 번호) (National Key Research and Development Program of China)
elderly
metabolic disorders
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
Sub-cohort 1 - Elderly Adults without chronic kidney disease (CKD) at Baseline | 해당 없음 |
Sub-cohort 2 - Elderly Patients with chronic kidney disease (CKD) | 해당 없음 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
incident CKD | For Sub-cohort 1 in Elderly Adults without CKD at Baseline, the primary outcome is incident CKD, which is defined as glomerular filtration rate (eGFR) \< 60 ml/(min·1.73m²) or positive urine protein; or the presence of a clear ICD-10 diagnostic code for CKD in medical records. | through study completion, an average of 1 year |
All-cause mortality | From date of enrollment until death from any cause, assessed up to 5 years | |
Progression to ESRD. | From date of enrollment until progression to ESRD or death from any cause, whichever came first, assessed up to 5 years |
INCLUSION CRITERIA:
- Baseline age ≥ 65 years.
- Availability of baseline data on serum creatinine and at least one urinary protein measurement.
- Urinary protein measurements include: UACR, UPCR, 24-hour urine protein quantification, and urine protein dipstick test.
- Baseline date requirement: Between January 1, 2010, and December 31, 2025.
- Follow-up requirement meeting at least one of the following: At least one serum creatinine measurement with an interval of ≥ 6 months after baseline. Occurrence of a primary endpoint event (new-onset CKD).
Exclusion Criteria:
Presence of CKD at baseline, defined as: Glomerular filtration rate (eGFR) < 60 ml/(min·1.73m²) or positive urine protein; or the presence of an ICD-10 diagnostic code for CKD in medical records.
For Sub-cohort 2 (CKD Patients), the inclusion and exclusion criteria are as follows:
Inclusion Criteria:
- Baseline age ≥ 65 years.
- Meeting the diagnostic criteria for CKD: Glomerular filtration rate (eGFR) < 60 ml/(min·1.73m²) or urine protein (UACR ≥ 30 mg/g); or based on ICD-10 codes.
- Baseline date requirement: Between January 1, 2010, and December 31, 2025.
- Follow-up requirement meeting at least one of the following:
Occurrence of a primary endpoint event (mortality, ESRD); At least one serum creatinine measurement with an interval of ≥ 6 months after baseline.
Exclusion Criteria:
- End-stage renal disease (ESRD) at baseline (eGFR < 15 ml/(min·1.73m²), or prior receipt of kidney transplant or dialysis), based on ICD codes).
- Diagnosis of acute kidney injury (AKI) within the preceding 3 months.
- New York Heart Association (NYHA) Class III or IV heart failure or occurrence of acute myocardial infarction within the preceding 6 months.
- Child-Pugh Class B or C liver cirrhosis.
- Malignant neoplasm.
Beijing Municipality