An observational study in Chronic Kidney Diseases and Chronic Kidney Disease-Mineral and Bone Disorder, sponsored by Limeng Chen. Recruiting at 40 sites in China. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by Limeng Chen · Observational
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.
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.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's planned enrollment of 10,254 is above the median of 213 across 834 observational studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Limeng Chen is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
This study plans to include hospitalized CKD patients who are not on dialysis and dialysis patients followed regularly in HD centers or PD centers.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Kidney damage for ≥ 3 months, and one of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: At the end of the enrollment.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At the end of the enrollment.
Plan to share: No — To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted.
Started Nov 2020 (actual). Primary completion is estimated for Dec 2024, 49 months after the start.
How these figures are worked out, and which studies are left out of them.
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