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Renal Insufficiency, ChronicC-STRIDENCT03041987

Chinese Cohort Study of Chronic Kidney Disease

An observational study of Renal Insufficiency, Chronic, run by Peking University First Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study aimed to explore underlying mechanisms of chronic kidney disease progression and its association with adverse consequences. It will enroll approximately 5000 pre-dialysis chronic kidney disease patients aged between 18 and 74 years in mainland China and follow-up for at least 5 years. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Renal Insufficiency, Chronic
How many people
5,000 participants
Where
1 siteChina
Study dates
1 Jan 2012to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 74 years
  • All sexes
  • Adult, Older adult

Study population: The study enrolled chronic kidney disease patients with a broad spectrum of renal diseases with various severities and phenotypes.

Who may be able to join

  • Participants should meet the following criteria of enrollment according to their etiology of nephrology.
  • For glomerular nephrology patients, the estimated glomerular filtration rate (eGFR) should be ≥15 ml/minute per 1.73m(2).
  • For diabetic nephrology patients, the defining eligibility was 15 ml/minute per 1.73m(2) ≤eGFR<60 ml/minute per 1.73m(2) or eGFR≥ 60 ml/minute per 1.73m(2) with "nephrotic range" proteinuria, which is defined as 24-hour urinary protein ≥3.5 g or urinary albumin creatinine ratio (ACR) ≥2 000 mg/g or corresponding values of urine dipstick test or urinary protein creatinine ratio (PCR).
  • For non-glomerular nephrology and non-diabetic nephrology patients, 15 ml/minute per 1.73m(2)≤eGFR<60 ml/minute per 1.73m(2) is set for enrollment.

Who cannot join

  • Participants meeting even one of the listed items should be excluded.
  • NYHA Class III or IV heart failure.
  • Chronic kidney disease caused by systemic inflammatory illness or autoimmune disease, such as lupus erythematosus.
  • Treated with immunosuppressive agents in the preceding 6 months to treat renal or immune disease.
  • Self-reported or known diagnosis of HIV infection and/or AIDS.
  • Isolated hematuria.
Show all 12Show fewer
  • Self-reported or known diagnosis of cirrhosis.
  • Pregnant or breast-feeding women.
  • Malignancy treated with chemotherapy within last 2 years.
  • Renal or other transplantation.
  • Hereditary kidney disease.
  • Participation in interventional clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

Other trials in China

About this study

This study aimed to explore underlying mechanisms of chronic kidney disease progression and its association with adverse consequences. It will enroll approximately 5000 pre-dialysis chronic kidney disease patients aged between 18 and 74 years in mainland China and follow-up for at least 5 years. Questionnaires, anthropometric measures, laboratory tests, and biomaterials will be collected at baseline and annually. The principal clinical outcomes of the study consist of renal disease events, cardiovascular events, and death.

Read the detailed description

The study is a multicenter prospective cohort study, aimed to explore underlying mechanisms of chronic kidney disease progression and its association with adverse consequences. The study will establish a baseline cohort of 5000 Chinese pre-dialysis chronic kidney disease patients, who will be followed up until death or dropout or starting renal replacement therapy. The follow-up will be conducted for at least 5 years. Their clinical information and biomaterials will be collected at baseline and then annually during follow-up.

The baseline visit includes the following items: detailed demographics; socioeconomic and health care services information; medical and family history; medication history; and questionnaires concerning quality of life, health behaviors, depressive and anxiety symptoms, cognitive function, and physical activity. Anthropometric measures (height, weight, waist circumference, hip circumference, resting blood pressure, heart rate, grip strength, and 15-feet measured walk) will also be collected. The laboratory parameters of chemistry test, intact parathyroid hormone, 24-hour urine electrolytes, protein creatinine ratio, and albumin creatinine ratio should also be collected for each participant and measured in the central laboratory. After the baseline visit, participants will return annually for follow-up visits and evaluation. The evaluating items of follow-up visits are similar to the baseline visit, and sample collection.

The principal clinical outcomes of the study can be broadly categorized as renal disease events, cardiovascular events, and death. Renal disease events include the incident end stage renal disease or significant loss of renal function.Cardiovascular events include acute myocardial infarction, unstable angina, hospitalization for congestive heart failure, incident serious cardiac arrhythmia, cerebrovascular events, and peripheral vascular diseases. Death is further clarified as cardiac, cerebrovascular, renal, others, or unknown.

Being tested
Demographic factors, biomedical measurements, drugs used for controlling metabolic disorders, etc
Keywords
Cohort studies, Prognosis
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Demographic factors, biomedical measurements, drugs used for controlling metabolic disorders, etcOther

Study groups in NCT03041987
Study groupRoleWhat they receive
Chronic Kidney DiseaseSpecified estimated glomerular filtration rate (eGFR) range according to different CKD etiologies. For glomerular nephrology patients, the eGFR should be ≥15 ml/minute per 1.73m(2). For diabetic nephrology patients, the defining eligibility was 15 ml/minute per 1.73m(2)≤eGFR <60 ml/minute per 1.73m(2) or eGFR≥ 60 ml/minute per 1.73m(2) with "nephrotic range" proteinuria, which is defined as 24-hour urinary protein ≥3.5 g or urinary albumin creatinine ratio ≥2 000 mg/g or corresponding values of urine dipstick test or urinary protein creatinine ratio. For non-glomerular nephrology and non-diabetic nephrology patients, 15 ml/minute per 1.73m(2) ≤eGFR<60 ml/minute per 1.73m(2) is set for enrollment.
Receives: Other: Demographic factors, biomedical measurements, drugs used for controlling metabolic disorders, etc

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. End stage renal disease or significant loss of renal function

    start of chronic dialysis or renal transplantation or irreversible development of glomerular filtration rate <15 ml/minute per 1.73m(2) or halving of estimated glomerular filtration rate or doubling of serum creatinine compared with the value of study entry

    Measured: from date of baseline examination until the date of first documented end stage renal disease or significant loss of renal function or date of death from any cause, whichever came first, up to 60 months

  2. Cardiovascular events

    acute myocardial infarction, unstable angina, hospitalization for congestive heart failure, incident serious cardiac arrhythmia (resuscitated cardiac arrest, ventricular fibrillation, sustained ventricular tachycardia, paroxysmal ventricular tachycardia, an initial episode of atrial fibrillation or flutter, severe bradycardia or heart block), cerebrovascular events (intraparenchymal hemorrhage, subarachnoid hemorrhage, cerebral infarction, cardioembolic cerebral infarction, etc.), and peripheral vascular diseases.

    Measured: from date of baseline examination until the date of first documented cardiovascular events or date of death from any cause, whichever came first, up to 60 months

  3. Death

    death from any cause

    Measured: from date of baseline examination until the date of death from any cause, up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2017 (estimated)
  2. Study start1 Jan 2012
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03041987
Sponsor's protocol ID
2011BAI10B01
Acronym
C-STRIDE
Status last verified
Nov 2023
First submitted
2 Feb 2017
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Gao B, Zhang L, Wang H, Zhao M. Chinese cohort study of chronic kidney disease: design and methods. Chin Med J (Engl). 2014;127(11):2180-5.

    PubMed 24902678
  • 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.

    PubMed 27647184
  • Yuan J, Zou XR, Han SP, Cheng H, Wang L, Wang JW, Zhang LX, Zhao MH, Wang XQ; C-STRIDE study group. Prevalence and risk factors for cardiovascular disease among chronic kidney disease patients: results from the Chinese cohort study of chronic kidney disease (C-STRIDE). BMC Nephrol. 2017 Jan 14;18(1):23. doi: 10.1186/s12882-017-0441-9.

    PubMed 28088175
  • Peng Z, Wang J, Yuan Q, Xiao X, Xu H, Xie Y, Wang W, Huang L, Zhong Y, Ao X, Zhang L, Zhao M, Tao L, Zhou Q; C-STRIDE study group. Clinical features and CKD-related quality of life in patients with CKD G3a and CKD G3b in China: results from the Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). BMC Nephrol. 2017 Oct 13;18(1):311. doi: 10.1186/s12882-017-0725-0.

    PubMed 29029600
  • Yan Z, Wang Y, Li S, Wang J, Zhang L, Tan H, Li S, Yang L, Pei H, Zhang L, Wang Y, Duan J, Jiao S, Zhao M, Fu S; China National Survey of Chronic Kidney Disease Working Group. Hypertension Control in Adults With CKD in China: Baseline Results From the Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). Am J Hypertens. 2018 Mar 10;31(4):486-494. doi: 10.1093/ajh/hpx222.

    PubMed 29304216
  • Zhang JJ, Yang L, Huang JW, Liu YJ, Wang JW, Zhang LX, Zhao MH, Liu ZS. Characteristics and comparison between diabetes mellitus and non-diabetes mellitus among chronic kidney disease patients: A cross-sectional study of the Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). Oncotarget. 2017 Nov 10;8(63):106324-106332. doi: 10.18632/oncotarget.22368. eCollection 2017 Dec 5.

    PubMed 29290951
  • Lv L, Wang F, Wu L, Wang JW, Cui Z, Hayek SS, Wei C, Reiser J, He K, Zhang L, Chen M, Zhao MH. Soluble urokinase-type plasminogen activator receptor and incident end-stage renal disease in Chinese patients with chronic kidney disease. Nephrol Dial Transplant. 2020 Mar 1;35(3):465-470. doi: 10.1093/ndt/gfy265.

    PubMed 30124995
  • Lv L, Wang J, Gao B, Wu L, Wang F, Cui Z, He K, Zhang L, Chen M, Zhao MH. Serum uromodulin and progression of kidney disease in patients with chronic kidney disease. J Transl Med. 2018 Nov 19;16(1):316. doi: 10.1186/s12967-018-1693-2.

    PubMed 30454063
  • Yuan Q, Wang J, Peng Z, Zhou Q, Xiao X, Xie Y, Wang W, Huang L, Tang W, Sun D, Zhang L, Wang F, Zhao MH, Tao L, He K, Xu H; C-STRIDE study group. Neutrophil-to-lymphocyte ratio and incident end-stage renal disease in Chinese patients with chronic kidney disease: results from the Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). J Transl Med. 2019 Mar 15;17(1):86. doi: 10.1186/s12967-019-1808-4.

    PubMed 30876475
  • Wu L, Li XQ, Chang DY, Zhang H, Li JJ, Wu SL, Zhang LX, Chen M, Zhao MH. Associations of urinary epidermal growth factor and monocyte chemotactic protein-1 with kidney involvement in patients with diabetic kidney disease. Nephrol Dial Transplant. 2020 Feb 1;35(2):291-297. doi: 10.1093/ndt/gfy314.

    PubMed 30357416
  • Liu B, Wang Q, Wang Y, Wang J, Zhang L, Zhao M; C-STRIDE study group. Utilization of antihypertensive drugs among chronic kidney disease patients: Results from the Chinese cohort study of chronic kidney disease (C-STRIDE). J Clin Hypertens (Greenwich). 2020 Jan;22(1):57-64. doi: 10.1111/jch.13761. Epub 2019 Dec 9.

    PubMed 31816171
  • Pu L, Zou Y, Wu SK, Wang F, Zhang Y, Li GS, Wang JW, Zhang LX, Zhao MH, Wang L; C-STRIDE study group. Prevalence and associated factors of depressive symptoms among chronic kidney disease patients in China: Results from the Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). J Psychosom Res. 2020 Jan;128:109869. doi: 10.1016/j.jpsychores.2019.109869. Epub 2019 Nov 13.

    PubMed 31739085
  • Chen L, Wang J, Huang X, Wang F, Liang W, He Y, Liao Y, Zhang L, Zhao M, Xiong Z; C-STRIDE study group. Association between diabetes mellitus and health-related quality of life among patients with chronic kidney disease: results from the Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). Health Qual Life Outcomes. 2020 Aug 3;18(1):266. doi: 10.1186/s12955-020-01519-5.

    PubMed 32746855
  • Wang Q, Wang Y, Wang J, Zhang L, Zhao MH; Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE). White-coat hypertension and incident end-stage renal disease in patients with non-dialysis chronic kidney disease: results from the C-STRIDE Study. J Transl Med. 2020 Jun 15;18(1):238. doi: 10.1186/s12967-020-02413-w.

    PubMed 32539728
  • Wang Q, Wang Y, Wang J, Zhang L, Zhao MH; C-STRIDE (Chinese Cohort Study of Chronic Kidney Disease)* dagger. Short-Term Systolic Blood Pressure Variability and Kidney Disease Progression in Patients With Chronic Kidney Disease: Results From C-STRIDE. J Am Heart Assoc. 2020 Jun 16;9(12):e015359. doi: 10.1161/JAHA.120.015359. Epub 2020 Jun 6.

    PubMed 32508195

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Insufficiency, Chronic, run by Peking University First Hospital 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 4 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2023. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

End stage renal disease or significant loss of renal function (time frame: from date of baseline examination until the date of first documented end stage renal disease or significant loss of renal function or date of death from any cause, whichever came first, up to 60 months). The study lists 3 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 NCT03041987, which also lists 24 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 18 Nov 2023.

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