Chinese Chronic Renal Insufficiency Study: Based on Smartphone Platform

• Conditions: Chronic Kidney Diseases

• Registration Number: NCT04229485
• Lead Sponsor: Limeng Chen

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.

Study Timeline

• Study First Submitted: 2019-12-29
• Status Verified: 2020-01
• Study Start: 2020-01-10
• Study First Submitted QC: 2020-01-12
• Last Update Submitted: 2020-01-16
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-21
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3360

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of progression to ESRD	2 year	begin to dialysis and kidney transplantation
cardiovascular event and all-cause mortality	2 year	diagnose as myocardial infarction, heart failure, stroke and cerebral hemorrhage

Secondary Outcome Measures

Name	Time	Method
the rate of eGFR decline	2 years	the rate of eGFR decline
bone mass change	2 years	the bone mass change based on DXR
Kidney Disease Outcomes Quality Initiative-Short Form 36	2 years	the scores change of Kidney Disease Outcomes Quality Initiative- Short Form 36 The score of Kidney Disease Outcomes Quality Initiative-Short Form 36 is between 0 and 100. The higher score means a better self-evaluation.
frailty	2 years	A frailty phenotype was established with five variables: unintentional weight loss, self-reported exhaustion, low energy expenditure, weak grip strength and low gait speed. Those with three or more of the five factors were judged to be frail, those with one or two factors as pre-frail, and those with no factors as not frail.
the way of dialysis initiation	2 years	record if the patient start dialysis with urgency and mode of dialysis

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China