Chinese CKD-MBD Prevalence Survey (CRISS-MBD)

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04714918
• Other study ID #: CRISS-MBD
• Status: Recruiting
• Start date: November 29, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Peking Union Medical College Hospital
• Contact: Peng Xia, MD
• Phone: +86-13811684903
• Email: 7-xp[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10254
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases
• Chronic Kidney Disease-Mineral and Bone Disorder
• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
China	Anshan Central Hospital, Lishan District	Anshan	Liaoning
China	Beijing Daxing District People's Hospital	Beijing	Beijing
China	Beijing Lu-He Hospital, Capital Medical University	Beijing	Beijing
China	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	The First Hospital of Fangshan District, Beijing	Beijing	Beijing
China	Benxi Steel General Hospital of Liaoning Health Industry Group	Benxi	Liaoning
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	Chongqing Hospital of Traditional Chinese Medicine	Chongqing	Chongqing
China	People's Hospital of Liangping District, Chongqing	Chongqing	Chongqing
China	The First Affiliated Hospital, Chongqing Medical University	Chongqing	Chongqing
China	The Ninth People's Hospital of Chongqing	Chongqing	Chongqing
China	The People's Hospital of Fengdu County	Chongqing	Chongqing
China	The People's Hospital of Nanchuan District, Chongqing	Chongqing	Chongqing
China	The Third Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Dalian University Affiliated Xinhua Hospital	Dalian	Liaoning
China	Shunde Hospital of Southern Medical University, The first People's Hospital of Shunde	Foshan	Guangdong
China	Fujian Provincial Hospital	Fuzhou	Fujian
China	Panyu Central Hospital	Guangzhou	Guangdong
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	People's Hospital of Longde County	Guyuan	Ningxia
China	Traditional Chinese Hospital of Guyuan	Guyuan	Ningxia
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The People's Hospital of Longhua, The Affiliated Hospital of Southern Medical University	Shenzhen	Guangdong
China	The Seventh Affiliated Hospital, Sun Yat-sen University	Shenzhen	Guangdong
China	The Fifth People's Hospital of Ningxia Hui Autonomous Region	Shizuishan	Ningxia
China	People's Hospital of Xinjiang Uygur Autonomous Region	Ürümqi	Xinjiang
China	People's Hospital of Tongxin County	Wuzhong	Ningxia
China	People's Hospital of Wuzhong	Wuzhong	Ningxia
China	People's Hospital of Yanchi County	Wuzhong	Ningxia
China	People's Hospital of Yuanzhou District	Wuzhong	Ningxia
China	Zhongshan Hospital Affiliated to Xiamen University	Xiamen	Fujian
China	Ningxia Chinese Medicine Research Center	Yinchuan	Ningxia
China	People's Hospital of Ningxia Hui Autonomous Region	Yinchuan	Ningxia
China	The First People's Hospital of Yinchuan	Yinchuan	Ningxia
China	Third People's Hospital of Yiyang	Yiyang	Hunan
China	Zhangzhou People's Hospital	Zhangzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Limeng Chen

Country where clinical trial is conducted

China, 

References & Publications (2)

Kong X, Zhang L, Zhang L, Chen N, Gu Y, Yu X, Liu W, Chen J, Peng L, Yuan W, Wu H, Chen W, Fan M, He L, Ding F, Chen X, Xiong Z, Zhang J, Jia Q, Shi W, Xing C, Tang X, Hou F, Shu G, Mei C, Wang L, Xu D, Ni Z, Zuo L, Wang M, Wang H. Mineral and bone disord — View Citation

Zhou C, Wang F, Wang JW, Zhang LX, Zhao MH. Mineral and Bone Disorder and Its Association with Cardiovascular Parameters in Chinese Patients with Chronic Kidney Disease. Chin Med J (Engl). 2016 Oct 5;129(19):2275-80. doi: 10.4103/0366-6999.190678. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.