NCT04714918

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,254

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

40 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

4.1 years

First QC Date

January 14, 2021

Last Update Submit

April 9, 2024

Conditions

Keywords

Chronic Kidney DiseasesChronic Kidney Disease-Mineral and Bone DisorderHypocalcemiaHyperphosphatemiaSecondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • The prevalence of hypocalcemia

    At the end of the enrollment.

  • The prevalence of secondary hyperparathyroidism

    At the end of the enrollment.

  • The prevalence of hypercalcemia

    At the end of the enrollment.

  • The prevalence of bone fracture

    At the end of the enrollment.

  • The prevalence of vascular calcification

    At the end of the enrollment.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • no available test results within 3 months prior to this study
  • no available information of medication or past medical history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (40)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Beijing Lu-He Hospital, Capital Medical University

Beijing, Beijing Municipality, 101149, China

RECRUITING

The First Hospital of Fangshan District, Beijing

Beijing, Beijing Municipality, 102400, China

RECRUITING

Beijing Daxing District People's Hospital

Beijing, Beijing Municipality, 102600, China

RECRUITING

The First Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Chongqing Hospital of Traditional Chinese Medicine

Chongqing, Chongqing Municipality, 400021, China

RECRUITING

The Ninth People's Hospital of Chongqing

Chongqing, Chongqing Municipality, 400700, China

RECRUITING

The Third Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 401120, China

RECRUITING

People's Hospital of Liangping District, Chongqing

Chongqing, Chongqing Municipality, 405200, China

RECRUITING

The People's Hospital of Fengdu County

Chongqing, Chongqing Municipality, 408200, China

RECRUITING

The People's Hospital of Nanchuan District, Chongqing

Chongqing, Chongqing Municipality, 408400, China

RECRUITING

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

Zhangzhou People's Hospital

Zhangzhou, Fujian, 363099, China

RECRUITING

Shunde Hospital of Southern Medical University, The first People's Hospital of Shunde

Foshan, Guangdong, 528300, China

RECRUITING

Panyu Central Hospital

Guangzhou, Guangdong, 511400, China

RECRUITING

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 520120, China

RECRUITING

The Seventh Affiliated Hospital, Sun Yat-sen University

Shenzhen, Guangdong, 518000, China

RECRUITING

The People's Hospital of Longhua, The Affiliated Hospital of Southern Medical University

Shenzhen, Guangdong, 518109, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

Third People's Hospital of Yiyang

Yiyang, Hunan, 413000, China

RECRUITING

Anshan Central Hospital, Lishan District

Anshan, Liaoning, 114000, China

RECRUITING

Benxi Steel General Hospital of Liaoning Health Industry Group

Benxi, Liaoning, 117000, China

RECRUITING

Dalian University Affiliated Xinhua Hospital

Dalian, Liaoning, 116001, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

Traditional Chinese Hospital of Guyuan

Guyuan, Ningxia, 756000, China

RECRUITING

People's Hospital of Longde County

Guyuan, Ningxia, 756300, China

RECRUITING

The Fifth People's Hospital of Ningxia Hui Autonomous Region

Shizuishan, Ningxia, 753000, China

RECRUITING

People's Hospital of Wuzhong

Wuzhong, Ningxia, 751100, China

RECRUITING

People's Hospital of Tongxin County

Wuzhong, Ningxia, 751300, China

RECRUITING

People's Hospital of Yanchi County

Wuzhong, Ningxia, 751500, China

RECRUITING

People's Hospital of Yuanzhou District

Wuzhong, Ningxia, 756000, China

RECRUITING

Ningxia Chinese Medicine Research Center

Yinchuan, Ningxia, 750001, China

RECRUITING

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, 750001, China

RECRUITING

The First People's Hospital of Yinchuan

Yinchuan, Ningxia, 750001, China

RECRUITING

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830001, China

NOT YET RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Renal Insufficiency, ChronicChronic Kidney Disease-Mineral and Bone DisorderHypocalcemiaHyperphosphatemiaHyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRicketsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesCalcium Metabolism DisordersVitamin D DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersHyperparathyroidismParathyroid DiseasesEndocrine System DiseasesWater-Electrolyte ImbalancePhosphorus Metabolism Disorders

Study Officials

  • Limeng Chen, MD, PhD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Xia, MD

CONTACT

Xiaohong Fan, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Director, Department of Nephrology

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 20, 2021

Study Start

November 29, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted.

Locations