Chinese Chronic Renal Insufficiency Study: Based on Smartphone Platform

NCT04229485 | Unknown

• 1 other identifier: C-CRISS
• Study Type: observational
• Target: 3,360
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center prospective cohort study. The purpose of this study is to investigate the relationship between bone metabolic markers and other non-traditional risk factors with kidney function progression, cardiovascular and cerebrovascular diseases, and bone loss in patients with CKD G3-5ND. In the meantime, this study is to explore a new mode of management and complication monitoring through mobile communication in chronic kidney disease patients.

Conditions

Chronic Kidney Diseases

Keywords

chronic kidney diseae; mineral bone disease; cardiovascular events; mobile communication

Outcome Measures

Primary Outcomes (2)

• incidence of progression to ESRD

  begin to dialysis and kidney transplantation

  2 year

• cardiovascular event and all-cause mortality

  diagnose as myocardial infarction, heart failure, stroke and cerebral hemorrhage

  2 year

Secondary Outcomes (5)

• the rate of eGFR decline

  2 years

• bone mass change

  2 years

• Kidney Disease Outcomes Quality Initiative-Short Form 36

  2 years

• frailty

  2 years

• the way of dialysis initiation

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CKD patients stage 3-5ND

You may qualify if:

• at least two measurements of serum Cr (with a minimum interval of 3 months), , 10≤eGFR≤60ml/min/1.73m\^2

You may not qualify if:

• Unable or unwilling to provide informed consent
• Patients attending oncology, psychiatry, human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), viral hepatitis (HBV or HCV) services
• Acute mycardial infarction within the last six months
• NYHA Class III or IV heart failure at baseline
• Ongoing chemotherapy or immunosuppressive therapy (in the preceding 6 months to treat renal or immune disease)
• Current renal replacement therapy
• Current pregnancy or breastfeeding women
• Any organ transplantation
• Currently participation in an interventional clinical trial

Sponsors & Collaborators

• Limeng Chen: lead
• First Hospital of China Medical University: collaborator
• People's Hospital of Xinjiang Autonomous Region: collaborator
• Fujian Provincial Hospital: collaborator
• Qianfoshan Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• The Seventh Affiliated Hospital of Sun Yat-sen University: collaborator
• People's Hospital of Ningxia Hui Autonomous Region: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (4)

• Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl (2011). 2017 Jul;7(1):1-59. doi: 10.1016/j.kisu.2017.04.001. Epub 2017 Jun 21. No abstract available.

  PMID: 30675420 BACKGROUND

• Bello AK, Alrukhaimi M, Ashuntantang GE, Basnet S, Rotter RC, Douthat WG, Kazancioglu R, Kottgen A, Nangaku M, Powe NR, White SL, Wheeler DC, Moe O. Complications of chronic kidney disease: current state, knowledge gaps, and strategy for action. Kidney Int Suppl (2011). 2017 Oct;7(2):122-129. doi: 10.1016/j.kisu.2017.07.007. Epub 2017 Sep 20.

  PMID: 30675426 BACKGROUND

• Dienemann T, Fujii N, Orlandi P, Nessel L, Furth SL, Hoy WE, Matsuo S, Mayer G, Methven S, Schaefer F, Schaeffner ES, Sola L, Stengel B, Wanner C, Zhang L, Levin A, Eckardt KU, Feldman HI. International Network of Chronic Kidney Disease cohort studies (iNET-CKD): a global network of chronic kidney disease cohorts. BMC Nephrol. 2016 Sep 2;17(1):121. doi: 10.1186/s12882-016-0335-2.

  PMID: 27590182 BACKGROUND

• 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.

  PMID: 27647184 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood, 24 hour urine

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Limeng Chen, MD, PhD

  Division of Nephrology, Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohong Fan, MD

CONTACT

86-13811559757; fxhcmu@163.com

Xuehan Zhang, MD

CONTACT

86-18612550476; zxhzpp@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine, Associate Chief of Nephrology Division

Study Record Dates

• First Submitted: December 29, 2019
• First Posted: January 18, 2020
• Study Start: January 10, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)