Clinical trial NCT04714918: Chinese CKD-MBD Prevalence Survey (CRISS-MBD)
Official title: Chinese Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) Prevalence Survey
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
Chronic Kidney Disease-Mineral and Bone Disorder
Keywords: Chronic Kidney Diseases
Chronic Kidney Disease-Mineral and Bone Disorder
Hypocalcemia
Hyperphosphatemia
Secondary Hyperparathyroidism
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 10254
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study plans to include hospitalized CKD patients who are not on dialysis and dialysis patients followed regularly in HD centers or PD centers.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The prevalence of hyperphosphatemia
timeFrame: At the end of the enrollment.
Secondary outcomes:
measure: The prevalence of hypocalcemia
timeFrame: At the end of the enrollment.
measure: The prevalence of secondary hyperparathyroidism
timeFrame: At the end of the enrollment.
measure: The prevalence of hypercalcemia
timeFrame: At the end of the enrollment.
measure: The prevalence of bone fracture
timeFrame: At the end of the enrollment.
measure: The prevalence of vascular calcification
timeFrame: At the end of the enrollment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Lu-He Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: The First Hospital of Fangshan District, Beijing
state: Beijing
city: Beijing
country: China
facility: Beijing Daxing District People's Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital, Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Hospital of Traditional Chinese Medicine
state: Chongqing
city: Chongqing
country: China
facility: The Ninth People's Hospital of Chongqing
state: Chongqing
city: Chongqing
country: China
facility: The Third Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: People's Hospital of Liangping District, Chongqing
state: Chongqing
city: Chongqing
country: China
facility: The People's Hospital of Fengdu County
state: Chongqing
city: Chongqing
country: China
facility: The People's Hospital of Nanchuan District, Chongqing
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Xiamen
country: China
facility: Zhongshan Hospital Affiliated to Xiamen University
state: Fujian
city: Zhangzhou
country: China
facility: Zhangzhou People's Hospital
state: Fujian
city: Foshan
country: China
facility: Shunde Hospital of Southern Medical University, The first People's Hospital of Shunde
state: Guangdong
city: Guangzhou
country: China
facility: Panyu Central Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
city: Shenzhen
country: China
facility: The Seventh Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: The People's Hospital of Longhua, The Affiliated Hospital of Southern Medical University
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Yiyang
country: China
facility: Third People's Hospital of Yiyang
state: Hunan
city: Anshan
country: China
facility: Anshan Central Hospital, Lishan District
state: Liaoning
city: Benxi
country: China
facility: Benxi Steel General Hospital of Liaoning Health Industry Group
state: Liaoning
city: Dalian
country: China
facility: Dalian University Affiliated Xinhua Hospital
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Guyuan
country: China
facility: Traditional Chinese Hospital of Guyuan
state: Ningxia
city: Guyuan
country: China
facility: People's Hospital of Longde County
state: Ningxia
city: Shizuishan
country: China
facility: The Fifth People's Hospital of Ningxia Hui Autonomous Region
state: Ningxia
city: Wuzhong
country: China
facility: People's Hospital of Wuzhong
state: Ningxia
city: Wuzhong
country: China
facility: People's Hospital of Tongxin County
state: Ningxia
city: Wuzhong
country: China
facility: People's Hospital of Yanchi County
state: Ningxia
city: Wuzhong
country: China
facility: People's Hospital of Yuanzhou District
state: Ningxia
city: Yinchuan
country: China
facility: Ningxia Chinese Medicine Research Center
state: Ningxia
city: Yinchuan
country: China
facility: People's Hospital of Ningxia Hui Autonomous Region
state: Ningxia
city: Yinchuan
country: China
facility: The First People's Hospital of Yinchuan
state: Ningxia
city: Ürümqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Peking Union Medical College Hospital
name: Limeng Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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 disorder in Chinese dialysis patients: a multicenter study. BMC Nephrol. 2012 Sep 21;13:116. doi: 10.1186/1471-2369-13-116.