Clinical trial NCT04229485: Chinese Chronic Renal Insufficiency Study: Based on Smartphone Platform
Official title: The Chinese Cohort Study of Chronic Kidney Disease Patients Followed on Smartphone Platform, a Multi-center Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Diseases
Keywords: chronic kidney diseae
mineral bone disease
cardiovascular events
mobile communication
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: First Hospital of China Medical University
name: People's Hospital of Xinjiang Autonomous Region
name: Fujian Provincial Hospital
name: Qianfoshan Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: The Seventh Affiliated Hospital of Sun Yat-sen University
name: People's Hospital of Ningxia Hui Autonomous Region
First posted: 2020-01-18
Enrollment: 3360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CKD patients stage 3-5ND

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.

Detailed description: Abnormal mineral bone metabolism of chronic kidney disease (CKD-MBD) is the most common complication of CKD. It involves kidney, bone metabolism, parathyroid gland, cardiovascular and cerebrovascular organs. It is an independent risk factor for progression of CKD to end-stage renal disease (ESRD), vascular and cardiac valve calcification, and cardiovascular and cerebrovascular events. However, less data concerning the relationship between bone metabolic index, such as high blood phosphorus and cardiovascular diseases, bone mass reduction and fracture is available in Chinese adult patients. This study is a multi-center prospective cohort study to explore the relationship between bone metabolic markers and other non-traditional risk factors with renal function progression, cardiovascular and cerebrovascular diseases, and bone loss in patients with CKD G3-5ND. Based on the sample size estimation, 3360 subjects should be enrolled in this study. The primary outcome is progression to ESRD (start dialysis or kidney transplantation) or doubling of serum creatinine, as well as cardiovascular events and all-cause mortality.

At present, the follow-up and the management of complications of CKD patients are not enough. The popularity of mobile communication in China provide the possibility to strengthen the follow-up and complications management in CKD patients and save human resources. This study is to explore a new mode of collecting datas through mobile communication in chronic kidney disease patients.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: incidence of progression to ESRD
timeFrame: 2 year
measure: cardiovascular event and all-cause mortality
timeFrame: 2 year
Secondary outcomes:
measure: the rate of eGFR decline
timeFrame: 2 years
measure: bone mass change
timeFrame: 2 years
measure: Kidney Disease Outcomes Quality Initiative-Short Form 36
timeFrame: 2 years
measure: frailty
timeFrame: 2 years
measure: the way of dialysis initiation
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Division of Nephrology, Peking Union Medical College Hospital
name: Limeng Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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.