Chronic Kidney Disease-Mineral and Bone Disorder, Chronic Kidney Diseases
Conditions
Keywords
Chronic Kidney Diseases, Chronic Kidney Disease-Mineral and Bone Disorder, Hypocalcemia, Hyperphosphatemia, Secondary Hyperparathyroidism
Brief summary
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
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.
Interventions
None listed
Sponsors
Limeng Chen
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Kidney damage for ≥ 3 months, and one of the following criteria: 1. Glomerular filtration rate (GFR) \<60 mL/min/1.73m2 for 3 months or more, irrespective of cause. 2. 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) 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The prevalence of hyperphosphatemia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The prevalence of hypocalcemia | At the end of the enrollment. | The prevalence of hypocalcemia (serum calcium \< 2.13mmol/L) in the whole study population and in participants with different CKD stages. |
| The prevalence of secondary hyperparathyroidism | At the end of the enrollment. | The prevalence of secondary hyperparathyroidism (iPTH \> 300pg/ml) in the whole study population and in participants with different CKD stages. |
| The prevalence of hypercalcemia | At the end of the enrollment. | The prevalence of hypercalcemia (serum calcium \> 2.70mmol/L) in the whole study population and in participants with different CKD stages. |
| The prevalence of bone fracture | At the end of the enrollment. | The prevalence of bone fracture in the whole study population and in participants with different CKD stages. |
| The prevalence of vascular calcification | At the end of the enrollment. | The prevalence of vascular calcification identified by CT scan or ultrasound in the whole study population and in participants with different CKD stages. |
Countries
China
Contacts
Primary ContactPeng Xia, MD
Backup ContactXiaohong Fan, MD
Outcome results
None listed