Chronic Kidney DiseasesC-CRISSNCT04229485
Chinese Chronic Renal Insufficiency Study: Based on Smartphone Platform
An observational study of Chronic Kidney Diseases, run by Limeng Chen at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- How many people
- 3,360 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CKD patients stage 3-5ND
Who may be able to join
- at least two measurements of serum Cr (with a minimum interval of 3 months), , 10≤eGFR≤60ml/min/1.73m^2
Who cannot join
- 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
Show all 9Show fewer
- Current pregnancy or breastfeeding women
- Any organ transplantation
- Currently participation in an interventional clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Xiaohong Fan, MD, 86-13811559757, fxhcmu@163.com
Limeng Chen, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Keywords
- chronic kidney diseae, mineral bone disease, cardiovascular events, mobile communication
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of progression to ESRD
begin to dialysis and kidney transplantation
Measured: 2 year
cardiovascular event and all-cause mortality
diagnose as myocardial infarction, heart failure, stroke and cerebral hemorrhage
Measured: 2 year
Secondary outcomes (5)
the rate of eGFR decline
the rate of eGFR decline
Measured: 2 years
bone mass change
the bone mass change based on DXR
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
the way of dialysis initiation
record if the patient start dialysis with urgency and mode of dialysis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start10 Jan 2020 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limeng Chen
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor-investigator, Limeng Chen, Peking Union Medical College Hospital
- Investigators
- Limeng Chen, MD, PhD, Principal investigator, Division of Nephrology, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229485
- Sponsor's protocol ID
- C-CRISS
- Acronym
- C-CRISS
- Status last verified
- Jan 2020
- First submitted
- 29 Dec 2019
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted
Publications
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.
PubMed 30675420Bello 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.
PubMed 30675426Dienemann 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.
PubMed 27590182Zhou 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.
PubMed 27647184
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chinese Cohort Study of Chronic Kidney Disease Patients Followed on Smartphone Platform, a Multi-center Observational Study
- ClinicalTrials.gov ID
- NCT04229485
- Acronym / sponsor ID
- C-CRISS / C-CRISS
- Conditions
- Chronic Kidney Diseases
- Keywords
- chronic kidney diseae, mineral bone disease, cardiovascular events, mobile communication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,360 participants (estimated)
- Lead sponsor
- Limeng ChenUniversity, hospital or other
- Collaborators
- 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
- Study start
- 10 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CKD patients stage 3-5ND
Key inclusion criteria (1 listed)
- at least two measurements of serum Cr (with a minimum interval of 3 months), , 10≤eGFR≤60ml/min/1.73m^2
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of progression to ESRD
Time frame: 2 year
begin to dialysis and kidney transplantation
cardiovascular event and all-cause mortality
Time frame: 2 year
diagnose as myocardial infarction, heart failure, stroke and cerebral hemorrhage
5 secondary outcomes
the rate of eGFR decline
Time frame: 2 years
bone mass change
Time frame: 2 years
Kidney Disease Outcomes Quality Initiative-Short Form 36
Time frame: 2 years
frailty
Time frame: 2 years
the way of dialysis initiation
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Background: PubMed 30675420Kidney 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.
- Background: PubMed 30675426Bello 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.
- Background: PubMed 27590182Dienemann 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.
- Background: PubMed 27647184Zhou 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.
- Individual participant dataSharing planned: No. To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Limeng Chen, MD, PhD principal investigator
Division of Nephrology, Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by Limeng Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohong Fan, MD (86-13811559757, fxhcmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of progression to ESRD (time frame: 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04229485, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2020.