Chinese Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) Prevalence Survey
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,254
- 试验地点
- 40
- 主要终点
- The prevalence of hyperphosphatemia
研究概览
简要总结
This is a multi-center cross sectional epidemiological study. The purpose of this study is to investigate the prevalence of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) in Chinese population.
详细描述
The prevalence of Chronic Kidney Disease (CKD) in Chinese population is over 10% and increasing rapidly. Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) is a constellation of conditions secondary to CKD, including 1) metabolic disorders of calcium, phosphorus and Parathyroid Hormone (PTH), 2) bone diseases and 3) calcifications in blood vessels and soft tissues. CKD-MBD could increase the risks of cardiovascular diseases and bone fracture and overall mortality. However, the data of prevalence of CKD-MBD in Chinese population with different CKD stages is lacking. This is a multi-center cross sectional epidemiological study. The purpose of this study is to investigate the prevalence of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) in Chinese population.This is a multi-center cross sectional epidemiological study. The purpose of this study is to investigate the prevalence of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) in Chinese population. A questionnaire was designed to collect the information of demographic data, medical history, laboratory test results and medications from the patients. Multistage stratified cluster sampling method will be used. Based on the sample size estimation, a total of 14-28 tertiary hospitals and 42-56 level II hospitals distributed in seven different geographic regions across China will be included. At least 9863 subjects will be enrolled. The primary outcome is the prevalence of CKD-MBD, including the prevalence of hypocalcemia, hyperphosphatemia and secondary hyperparathyroidism.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney damage for ≥ 3 months, and one of the following criteria:
- •Glomerular filtration rate (GFR) <60 mL/min/1.73m2 for 3 months or more, irrespective of cause.
- •proteinuria (>30 mg of urinary albumin excretion per gram of urinary creatinine, > 50 mg of urinary protein excretion per gram of urinary creatinine, >1+ for proteinuria in dipstick, > 0.3g of 24 hour urine protein)
- •structural renal abnormalities
- •hospitalized patients not on dialysis or dialysis patients followed regularly in Hemodialysis centers or Peritoneal Dialysis centers
排除标准
- •no available test results within 3 months prior to this study
- •no available information of medication or past medical history
结局指标
主要结局
The prevalence of hyperphosphatemia
时间窗: At the end of the enrollment.
The prevalence of hyperphosphatemia (serum phosphate \> 1.45mmol/L) in the whole study population and in participants with different CKD stages.
次要结局
- The prevalence of hypocalcemia(At the end of the enrollment.)
- The prevalence of secondary hyperparathyroidism(At the end of the enrollment.)
- The prevalence of bone fracture(At the end of the enrollment.)
- The prevalence of hypercalcemia(At the end of the enrollment.)
- The prevalence of vascular calcification(At the end of the enrollment.)
研究者
Limeng Chen
Deputy Director, Department of Nephrology
Peking Union Medical College Hospital