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Chronic Kidney DiseasesNCT04714918

Chinese CKD-MBD Prevalence Survey (CRISS-MBD)

An observational study of Chronic Kidney Diseases and Chronic Kidney Disease-Mineral and Bone Disorder, run by Limeng Chen at 40 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
How many people
10,254 participants
Where
40 sitesChina
Study dates
29 Nov 2020to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

40 sites in 1 country.

Peng Xia, MD contact

+86-13811684903

7-xp@163.com

Xiaohong Fan, MD contact

+86-13811559757

fxhcmu@163.com

40 sites in 1 country

China40 sites, 40 recruiting
  • Anshan Central Hospital, Lishan District

    Anshan, Liaoning, 114000

    Cong Ma, BM, +86-13050031079, macong307@sina.com

    Ruiting Lv, BM, +86-13887921956, 273387890@qq.com

    Recruiting
  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070

    Jing Liu, MD, +86-18910390108, proprock@126.com

    Yin Zhang, PhD, +86-15801438634, Zhangyin1228@163.com

    Recruiting
  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100730

    Guojuan Zhang, MD, +86-10-58268488, guojuanzhang@163.com

    Kangkang Song, MD, +86-10-58268478, songkangkang0122@sina.com

    Recruiting
  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Peng Xia, MD, +86-1381168403, 7-xp@163.com

    Xiaohong Fan, MD, +86-13811559757, fxhcmu@163.com

    Recruiting
  • Beijing Lu-He Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101149

    Zhongxin Li, MD, +86-15117969360, 13621211613@139.com

    Chunxia Shi, MM, +86-18701377094, 422601904@qq.com

    Recruiting
  • The First Hospital of Fangshan District, Beijing

    Beijing, Beijing Municipality, 102400

    Xufang Yu, MM, +86-13621246651, yuxufang2@163.com

    Xin Jiang, BM, +86-13261156110, 1029379965@qq.com

    Recruiting
  • Beijing Daxing District People's Hospital

    Beijing, Beijing Municipality, 102600

    Peiyi Zhou, M.D., +86-13240985938, pyzhou81@163.com

    Peiyi Zhou, M.D.

    Recruiting
  • Benxi Steel General Hospital of Liaoning Health Industry Group

    Benxi, Liaoning, 117000

    Jia Liu, MM, +86-13274255531, 978470568@qq.com

    Wei Wei, MM, +86-18041440516, 974859394@qq.com

    Recruiting
  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

    Cuifang Li, MM, 15274987725, 810314451@qq.com

    Hui Xu, MD

    Recruiting
  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

    Enhao Yang, MD, PhD, +86-13983836679, 379239336@qq.com

    Wen Wen, MSc, +86-15683168986, 86140771@qq.com

    Recruiting
  • Chongqing Hospital of Traditional Chinese Medicine

    Chongqing, Chongqing Municipality, 400021

    Weijian Xiong, BM, +86-13628371818, xwj950806@126.com

    Ling Zhang, BM, +86-13370768750, 1648770473@qq.com

    Recruiting
  • The Ninth People's Hospital of Chongqing

    Chongqing, Chongqing Municipality, 400700

    Yuanjiang Liao, MM, +86-13272911037, lyj730225@163.com

    Yan Shi, MM, +86-13594161996, cqyuxiaoke@163.com

    Recruiting
  • The Third Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 401120

    Shuyu Gong, MM, +86-17380549355, 997283452@qq.com

    Jurong Yang, MD, +86-15802391006, 15802391006@163.com

    Recruiting
  • People's Hospital of Liangping District, Chongqing

    Chongqing, Chongqing Municipality, 405200

    Hongwen Zhou, MM, +86-13668488428, 910741512@qq.com

    Dongju Liu, BM, +86-13628460275, imagiczhou@163.com

    Recruiting
  • The People's Hospital of Fengdu County

    Chongqing, Chongqing Municipality, 408200

    Chenghui Tao, BM, +86-13509466553, 542505613@qq.com

    Yang Liu, +86-18372552345

    Recruiting
  • The People's Hospital of Nanchuan District, Chongqing

    Chongqing, Chongqing Municipality, 408400

    Jie Huo, BM, +86-13896624493, 3127075673@qq.com

    You Zhang, BM, +86-17323940871, 1464307302@qq.com

    Recruiting
  • Dalian University Affiliated Xinhua Hospital

    Dalian, Liaoning, 116001

    Lin Wang, MM, +86-13940804711, wanglinxinhua@126.com

    Qiangqiang Liu, MM, +86-13591717165, liuqiang0720@163.com

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

    Foshan, Guangdong, 528300

    Xianrui Dou, MD, +86-18825438838, betty9911@163.com

    Jianyi Pan, MM, +86-13929129228, 61962030@qq.com

    Recruiting
  • Fujian Provincial Hospital

    Fuzhou, Fujian, 350001

    Weihua Liu, MM, 13599394882, 305855638@qq.com

    Miao Lin, MD, 13506993517, 10151246@qq.com

    Recruiting
  • Panyu Central Hospital

    Guangzhou, Guangdong, 511400

    Rongjun Liu, MD, +86-15920596895, liuerita85@163.com

    Jieping Feng, MM, +86-13928786003, Fengjieping090206@126.com

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

    Guangzhou, Guangdong, 520120

    Qiongqiong Yang, MD, +86-13826204650, yangqq@mail.sysu.edu.cn

    Rong Huang, MD, +86-18825135993, huangr93@mail.sysu.edu.cn

    Recruiting
  • Traditional Chinese Hospital of Guyuan

    Guyuan, Ningxia, 756000

    Shiqiang Shi, BM, +86-13995049152, 290557010@qq.com

    Wei Ma, BM, +86-15209676228, 290557010@qq.com

    Recruiting
  • People's Hospital of Longde County

    Guyuan, Ningxia, 756300

    Kangzhong Zhang, BM, +86-18095402511, 351600801@qq.com

    Lang Luo, BM, +86-18295687489, 810830016@qq.com

    Recruiting
  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Lijun Mou, MD, PhD, +86-13757164624, tiantangmou@126.com

    Lijun Mou, MD, PhD

    Recruiting
  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

    Yunhua Liao, MM, +86-13878889238, 993237105@qq.com

    Zhenhua Yang, MD, +86-13978806396, 593456108@qq.com

    Recruiting
  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Xinwang Zhu, MD, PhD, +86-13804056472, zhuxinwang_cmu@126.com

    Li Yao, MD, PhD

    Recruiting
  • The Seventh Affiliated Hospital, Sun Yat-sen University

    Shenzhen, Guangdong, 518000

    Zhihua Zheng, MD, +86-13922298682, zhihuazheng@126.com

    Ting Zhu, PhD, +86-15521189331, ztzoe_093@163.com

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

    Shenzhen, Guangdong, 518109

    Mingliang Hu, MD, +86-15112555656, hubright@foxmail.com

    Liting Xu, MM, +86-15625043662, 2423377940@qq.com

    Recruiting
  • The Fifth People's Hospital of Ningxia Hui Autonomous Region

    Shizuishan, Ningxia, 753000

    Fengxia Wang, MM, +86-13139529067, wangfengxia1232006@126.com

    Yupu Dou, MM, +86-13619516696, douyupudyp@163.com

    Recruiting
  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 830001

    Xueqin Zhang, MM, +86-15899197875, 806593091@qq.com

    Jing Zhuang, MM, +86-13659928280, 2098602833@qq.com

    Not yet recruiting
  • People's Hospital of Wuzhong

    Wuzhong, Ningxia, 751100

    Hongyan Yan, MM, +86-13009722115, zwn080504@163.com

    Xiaoxia Luo, MM, +86-18795017564, 1260432244@qq.com

    Recruiting
  • People's Hospital of Tongxin County

    Wuzhong, Ningxia, 751300

    Weiquan Zhang, BM, +86-13995454338, 1207829520@qq.com

    Lingyan Ma, BM, +86-14760536533, 850862838@qq.com

    Recruiting
  • People's Hospital of Yanchi County

    Wuzhong, Ningxia, 751500

    Zhiwen Zhang, BM, +86-13909534706, ywkzzw@163.com

    Zhiwen Zhang, BM

    Recruiting
  • People's Hospital of Yuanzhou District

    Wuzhong, Ningxia, 756000

    Lili Ao, BM, +86-13389547533, sea.ao@163.com

    Bo Lu, BM, +86-15009648668

    Recruiting
  • Zhongshan Hospital Affiliated to Xiamen University

    Xiamen, Fujian, 361000

    Xiaodan Guo, MM, +86-15880272062, guoxiaodanzz@163.com

    Tianjun Guan, MD, +86-13950199068, guantianjun@aliyun.com

    Recruiting
  • Ningxia Chinese Medicine Research Center

    Yinchuan, Ningxia, 750001

    Jinhong Lu, BM, +86-13995116661, Lujinhong0608@126.com

    Jiaxiu Li, MM, +86-18298348565, 1054100560@qq.com

    Recruiting
  • People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, Ningxia, 750001

    Yali Zheng, MD, +86-13639505291, 424570556@qq.com

    Li Cao, MM, +86-18298348565, 1054100560@qq.com

    Recruiting
  • The First People's Hospital of Yinchuan

    Yinchuan, Ningxia, 750001

    Peng Zhang, BM, +86-13995412502, Zhangpeng990212@163.com

    Liyuan Ma, MM, +86-13619519668, 1135550734@qq.com

    Recruiting
  • Third People's Hospital of Yiyang

    Yiyang, Hunan, 413000

    Xiaoyan Hong, BM, +86-13617376578, 452688345@qq.com

    Sha Li, BM, +86-13487801219, 695133217@qq.com

    Recruiting
  • Zhangzhou People's Hospital

    Zhangzhou, Fujian, 363099

    Pengfei Huang, BM, +86-18750747718, 552302627@qq.com

    Rui Wu, BM

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Keywords
Chronic Kidney Diseases, Chronic Kidney Disease-Mineral and Bone Disorder, Hypocalcemia, Hyperphosphatemia, Secondary Hyperparathyroidism
Medical subject headings
Renal Insufficiency, Chronic, Chronic Kidney Disease-Mineral and Bone Disorder, Hypocalcemia, Hyperphosphatemia, Hyperparathyroidism, Secondary

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At the end of the enrollment.

Secondary outcomes (5)
  1. 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.

    Measured: At the end of the enrollment.

  2. 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.

    Measured: At the end of the enrollment.

  3. 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.

    Measured: At the end of the enrollment.

  4. The prevalence of bone fracture

    The prevalence of bone fracture in the whole study population and in participants with different CKD stages.

    Measured: At the end of the enrollment.

  5. 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.

    Measured: At the end of the enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2021
  2. Study start29 Nov 2020
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
10,254 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04714918
Sponsor's protocol ID
CRISS-MBD
Status last verified
Apr 2024
First submitted
14 Jan 2021
Last updated
10 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted.

Publications

  • 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.

    PubMed 27647184
  • 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.

    PubMed 22994525

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Diseases and Chronic Kidney Disease-Mineral and Bone Disorder, run by Limeng Chen at 40 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Peng Xia, MD (+86-13811684903, 7-xp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The prevalence of hyperphosphatemia (time frame: At the end of the enrollment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04714918, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.

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