Chinese Chronic Renal Insufficiency Study: Based on Smartphone Platform (C-CRISS)

January 16, 2020 updated by: Limeng Chen

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

3360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaohong Fan, MD
  • Phone Number: 86-13811559757
  • Email: fxhcmu@163.com

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

CKD patients stage 3-5ND

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate of eGFR decline
Time Frame: 2 years
the rate of eGFR decline
2 years
bone mass change
Time Frame: 2 years
the bone mass change based on DXR
2 years
Kidney Disease Outcomes Quality Initiative-Short Form 36
Time Frame: 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.
2 years
frailty
Time Frame: 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.
2 years
the way of dialysis initiation
Time Frame: 2 years
record if the patient start dialysis with urgency and mode of dialysis
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Limeng Chen

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 10, 2020

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 29, 2019

First Submitted That Met QC Criteria

January 12, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

January 21, 2020

Last Update Submitted That Met QC Criteria

January 16, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-CRISS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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