Chronic Kidney Diseases
Conditions
Keywords
chronic kidney diseae, mineral bone disease, cardiovascular events, mobile communication
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.
Interventions
None listed
Sponsors
First Hospital of China Medical University
People's Hospital of Xinjiang Autonomous Region
Fujian Provincial Hospital
Qianfoshan Hospital
First Affiliated Hospital Xi'an Jiaotong University
The Seventh Affiliated Hospital of Sun Yat-sen University
People's Hospital of Ningxia Hui Autonomous Region
Limeng Chen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| the rate of eGFR decline | 2 years | the rate of eGFR decline |
| the way of dialysis initiation | 2 years | record if the patient start dialysis with urgency and mode of dialysis |
| 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. |
| bone mass change | 2 years | the bone mass change based on DXR |
Countries
China
Contacts
Primary ContactXiaohong Fan, MD
Backup ContactXuehan Zhang, MD
Outcome results
None listed