Chinese CKD-MBD Prevalence Survey (CRISS-MBD)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Chinese Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) Prevalence Survey

Conditions
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Chronic Kidney Diseases, Chronic Kidney Disease-Mineral and Bone Disorder

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: no available test results within 3 months prior to this study no available information of medication or past medical history
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of hyperphosphatemia | The prevalence of hyperphosphatemia (serum phosphate > 1.45mmol/L) in the whole study population and in participants with different CKD stages. | At the end of the enrollment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of hypocalcemia | The prevalence of hypocalcemia (serum calcium < 2.13mmol/L) in the whole study population and in participants with different CKD stages. | At the end of the enrollment. | 
| The prevalence of secondary hyperparathyroidism | The prevalence of secondary hyperparathyroidism (iPTH > 300pg/ml) in the whole study population and in participants with different CKD stages. | At the end of the enrollment. | 
| The prevalence of hypercalcemia | The prevalence of hypercalcemia (serum calcium > 2.70mmol/L) in the whole study population and in participants with different CKD stages. | At the end of the enrollment. | 
| The prevalence of bone fracture | The prevalence of bone fracture in the whole study population and in participants with different CKD stages. | At the end of the enrollment. | 
| The prevalence of vascular calcification | The prevalence of vascular calcification identified by CT scan or ultrasound in the whole study population and in participants with different CKD stages. | At the end of the enrollment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Diseases, Chronic Kidney Disease-Mineral and Bone Disorder, Hypocalcemia, Hyperphosphatemia, Secondary Hyperparathyroidism