Chinese Cohort Study of Chronic Kidney Disease (C-STRIDE)

November 14, 2023 updated by: Minghui Zhao, Peking University First Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital

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 to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.
  • 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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic Kidney Disease
Specified 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.
Other: Demographic factors, biomedical measurements, drugs used for controlling metabolic disorders, etc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
Cardiovascular events
Time Frame: 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
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.
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
Death
Time Frame: from date of baseline examination until the date of death from any cause, up to 60 months
death from any cause
from date of baseline examination until the date of death from any cause, up to 60 months

Collaborators and Investigators

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

Sponsor

Peking University First Hospital

Collaborators

The First Affiliated Hospital with Nanjing Medical University
The First Affiliated Hospital of Anhui Medical University
Xiangya Hospital of Central South University
The Second Hospital of Hebei Medical University
Peking University Third Hospital
West China Hospital
Qilu Hospital of Shandong University
Shengjing Hospital
Shandong Provincial Hospital
Beijing Hospital
The First Affiliated Hospital of Zhengzhou University
Affiliated Hospital of Hebei University
Guizhou Provincial People's Hospital
Qianfoshan Hospital
Tianjin Medical University General Hospital
Dongzhimen Hospital, Beijing
Zhejiang University
Xinqiao Hospital of Chongqing
The Second Affiliated Hospital of Chongqing Medical University
Peking University Shenzhen Hospital
General Hospital of Ningxia Medical University
Tianjin Medical University Second Hospital
First Affiliated Hospital of Xinjiang Medical University
Sichuan Provincial People's Hospital
First Affiliated Hospital of Chongqing Medical University
Beijing Boai Hospital
The First Affiliated Hospital of Dalian Medical University
Second Hospital of Shanxi Medical University
The Second Hospital of Anhui Medical University
First Affiliated Hospital of Chengdu Medical College
The Second Affiliated Hospital of Kunming Medical University
The First Affiliated Hospital of BaoTou Medical College
First Affiliated Hospital of Guangxi Medical University
the Affiliated Hospital of Hubei Traditional Chinese Medical College
Chifeng Second Hospital
Minhang Central Hospital
the First Affiliated Hospital of the Medical College of Shihezi University
Yuxi City People's Hospital

Investigators

  • Principal Investigator: Minghui Zhao, MD, Ph.D., Peking University First Hospital

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 (Actual)

January 1, 2012

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 2, 2017

First Submitted That Met QC Criteria

February 2, 2017

First Posted (Estimated)

February 3, 2017

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011BAI10B01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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