Chinese Chronic Renal Insufficiency Study: Based on Smartphone Platform

Chronic Kidney Diseases Clinical Trial

— C-CRISS  

Official title:

The Chinese Cohort Study of Chronic Kidney Disease Patients Followed on Smartphone Platform, a Multi-center Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04229485
• Other study ID #: C-CRISS
• Status: Not yet recruiting
• Start date: January 10, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2020
• Source: Peking Union Medical College Hospital
• Contact: Xiaohong Fan, MD
• Phone: 86-13811559757
• Email: fxhcmu[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3360
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (8)

Lead Sponsor	Collaborator
Limeng Chen	First Affiliated Hospital Xi'an Jiaotong University, First Hospital of China Medical University, Fujian Provincial Hospital, People's Hospital of Ningxia Hui Autonomous Region, People's Hospital of Xinjiang Autonomous Region, Seventh Affiliated Hospital of Sun Yat-sen University, Shandong Provincial Qianfoshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Bello AK, Alrukhaimi M, Ashuntantang GE, Basnet S, Rotter RC, Douthat WG, Kazancioglu R, Köttgen 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. Review. — View Citation

Dienemann T, Fujii N, Orlandi P, Nessel L, Furth SL, Hoy WE, Matsuo S, Mayer G, Methven S, Schaefer F, Schaeffner ES, Solá 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. — View 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. Erratum in: Kidney Int Suppl (2011). 2017 Dec;7(3):e1. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of progression to ESRD	begin to dialysis and kidney transplantation	2 year
Primary	cardiovascular event and all-cause mortality	diagnose as myocardial infarction, heart failure, stroke and cerebral hemorrhage	2 year
Secondary	the rate of eGFR decline	the rate of eGFR decline	2 years
Secondary	bone mass change	the bone mass change based on DXR	2 years
Secondary	Kidney Disease Outcomes Quality Initiative-Short Form 36	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.	2 years
Secondary	frailty	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.	2 years
Secondary	the way of dialysis initiation	record if the patient start dialysis with urgency and mode of dialysis	2 years