Assessment of Subclinical Renal Dysfunction in Rheumatoid Arthritis and Its Association With Disease Activity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Prevalence of subclinical renal dysfunction
研究概览
简要总结
This comparative cross-sectional study aims to determine the prevalence of subclinical renal dysfunction in patients with rheumatoid arthritis and to evaluate its association with disease activity and inflammatory markers compared with age- and sex-matched healthy controls at Assiut University Hospitals.
详细描述
Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease that may be associated with early renal involvement even before overt chronic kidney disease develops. Subclinical renal dysfunction refers to early impairment of renal function that is not detected by conventional serum creatinine alone.
This hospital-based comparative cross-sectional study will include two groups: patients with rheumatoid arthritis diagnosed according to the 2010 ACR/EULAR classification criteria, and age- and sex-matched apparently healthy controls. All participants will undergo clinical assessment, disease activity evaluation using DAS28, laboratory investigations including estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR), and renal ultrasonography. The study will determine the prevalence of subclinical renal dysfunction and assess its association with disease activity, inflammatory markers, serological markers, disease duration, and treatment-related factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •For patient group: Diagnosis of rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria
- •For control group: Age- and sex-matched apparently healthy individuals with no history of autoimmune disease or chronic kidney disease
- •Willingness to provide written informed consent
排除标准
- •Known chronic kidney disease
- •Acute kidney injury
- •Diabetes mellitus
- •Uncontrolled hypertension
- •Active urinary tract infection
- •Pregnancy
- •History of obstructive uropathy or renal stones
- •Systemic lupus erythematosus or other connective tissue diseases
- •Malignancy
- •Patients on maintenance hemodialysis
研究组 & 干预措施
Healthy controls (n=40)
Age- and sex-matched apparently healthy individuals with no history of autoimmune disease or chronic kidney disease.
Rheumatoid arthritis patients (n=80)
Adult patients diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria attending the Rheumatology outpatient clinic and inpatient wards at Assiut University Hospitals.
结局指标
主要结局
Prevalence of subclinical renal dysfunction
时间窗: Baseline
Proportion of participants with subclinical renal dysfunction, defined as the presence of reduced estimated glomerular filtration rate (eGFR \< 90 mL/min/1.73 m²) and/or elevated urine albumin-to-creatinine ratio (UACR ≥ 30 mg/g) in the absence of previously diagnosed chronic kidney disease.
次要结局
- Comparison of eGFR between groups(Baseline)
- Comparison of UACR between groups(Baseline)
- Association with disease activity(Baseline)
- Association with inflammatory markers(Baseline)
- Independent predictors of subclinical renal dysfunction(Baseline)
- Correlation of subclinical renal dysfunction with disease activity(Baseline)
- Correlation of subclinical renal dysfunction with inflammatory markers(Baseline)
研究者
Nermeen Ebrahim Barsoum
An internal medicine resident physician
Assiut University