Chinese CKD-MBD Prevalence Survey (CRISS-MBD)

Recruiting

• Conditions: Chronic Kidney Disease-Mineral and Bone Disorder; Chronic Kidney Diseases

• Registration Number: NCT04714918
• Lead Sponsor: Limeng Chen

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.

Study Timeline

• Study Start: 2020-11-29
• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10254

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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.

Trial Locations

Locations (40)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Tongren Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Lu-He Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

The First Hospital of Fangshan District, Beijing; 🇨🇳 Beijing, Beijing, China

Beijing Daxing District People's Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital, Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

Chongqing Hospital of Traditional Chinese Medicine; 🇨🇳 Chongqing, Chongqing, China

The Ninth People's Hospital of Chongqing; 🇨🇳 Chongqing, Chongqing, China

The Third Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

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