Chinese CKD-MBD Prevalence Survey (CRISS-MBD)

Sponsor

Limeng Chen (Other)

Overall Status

Recruiting

CT.gov ID

NCT04714918

Collaborator

(none)

10,254

Enrollment

Locations

Anticipated Duration (Months)

256.4

Patients Per Site

10.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases Chronic Kidney Disease-Mineral and Bone Disorder

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 Design

Study Type:

Observational

Anticipated Enrollment :

10254 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Nov 29, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Kidney damage for ≥ 3 months, and one of the following criteria:

Glomerular filtration rate (GFR) <60 mL/min/1.73m2 for 3 months or more, irrespective of cause.
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)

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing	China	100070
2	Beijing Tongren Hospital, Capital Medical University	Beijing	Beijing	China	100730
3	Peking Union Medical College Hospital	Beijing	Beijing	China	100730
4	Beijing Lu-He Hospital, Capital Medical University	Beijing	Beijing	China	101149
5	The First Hospital of Fangshan District, Beijing	Beijing	Beijing	China	102400
6	Beijing Daxing District People's Hospital	Beijing	Beijing	China	102600
7	The First Affiliated Hospital, Chongqing Medical University	Chongqing	Chongqing	China	400016
8	Chongqing Hospital of Traditional Chinese Medicine	Chongqing	Chongqing	China	400021
9	The Ninth People's Hospital of Chongqing	Chongqing	Chongqing	China	400700
10	The Third Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing	China	401120
11	People's Hospital of Liangping District, Chongqing	Chongqing	Chongqing	China	405200
12	The People's Hospital of Fengdu County	Chongqing	Chongqing	China	408200
13	The People's Hospital of Nanchuan District, Chongqing	Chongqing	Chongqing	China	408400
14	Fujian Provincial Hospital	Fuzhou	Fujian	China	350001
15	Zhongshan Hospital Affiliated to Xiamen University	Xiamen	Fujian	China	361000
16	Zhangzhou People's Hospital	Zhangzhou	Fujian	China	363099
17	Shunde Hospital of Southern Medical University, The first People's Hospital of Shunde	Foshan	Guangdong	China	528300
18	Panyu Central Hospital	Guangzhou	Guangdong	China	511400
19	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong	China	520120
20	The Seventh Affiliated Hospital, Sun Yat-sen University	Shenzhen	Guangdong	China	518000
21	The People's Hospital of Longhua, The Affiliated Hospital of Southern Medical University	Shenzhen	Guangdong	China	518109
22	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi	China	530021
23	Xiangya Hospital of Central South University	Changsha	Hunan	China	410008
24	Third People's Hospital of Yiyang	Yiyang	Hunan	China	413000
25	Anshan Central Hospital, Lishan District	Anshan	Liaoning	China	114000
26	Benxi Steel General Hospital of Liaoning Health Industry Group	Benxi	Liaoning	China	117000
27	Dalian University Affiliated Xinhua Hospital	Dalian	Liaoning	China	116001
28	The First Hospital of China Medical University	Shenyang	Liaoning	China	110001
29	Traditional Chinese Hospital of Guyuan	Guyuan	Ningxia	China	756000
30	People's Hospital of Longde County	Guyuan	Ningxia	China	756300
31	The Fifth People's Hospital of Ningxia Hui Autonomous Region	Shizuishan	Ningxia	China	753000
32	People's Hospital of Wuzhong	Wuzhong	Ningxia	China	751100
33	People's Hospital of Tongxin County	Wuzhong	Ningxia	China	751300
34	People's Hospital of Yanchi County	Wuzhong	Ningxia	China	751500
35	People's Hospital of Yuanzhou District	Wuzhong	Ningxia	China	756000
36	Ningxia Chinese Medicine Research Center	Yinchuan	Ningxia	China	750001
37	People's Hospital of Ningxia Hui Autonomous Region	Yinchuan	Ningxia	China	750001
38	The First People's Hospital of Yinchuan	Yinchuan	Ningxia	China	750001
39	People's Hospital of Xinjiang Uygur Autonomous Region	Ürümqi	Xinjiang	China	830001
40	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310000