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Trial record 10 of 528 for:    Recruiting, Not yet recruiting, Available Studies | "Renal Insufficiency, Chronic"

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

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ClinicalTrials.gov Identifier: NCT03041987
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : April 17, 2018
Sponsor:
Collaborators:
Peking University Third Hospital
Dongzhimen Hospital, Beijing
Beijing Hospital
Beijing Boai Hospital
Peking University Shenzhen Hospital
First Affiliated Hospital of Guangxi Medical University
Guizhou Provincial People's Hospital
the Affiliated Hospital of Chengde Medical Colledge
Affiliated Hospital of Hebei University
The Second Hospital of Hebei Medical University
The First Affiliated Hospital of Zhengzhou University
the Affiliated Hospital of Hubei Traditional Chinese Medical College
Xiangya Hospital of Central South University
The First Affiliated Hospital with Nanjing Medical University
The First Affiliated Hospital of Dalian Medical University
Chifeng Second Hospital
The First Affiliated Hospital of BaoTou Medical College
Qilu Hospital of Shandong University
Shandong Provincial Hospital
Qianfoshan Hospital
Second Hospital of Shanxi Medical University
Minhang Central Hospital
West China Hospital
Sichuan Provincial People's Hospital
Tianjin Medical University General Hospital
Tianjin Medical University Second Hospital
the First Affiliated Hospital of the Medical College of Shihezi University
First Affiliated Hospital of Xinjiang Medical University
The Second Affiliated Hospital of Kunming Medical University
Yuxi City People’s Hospital
Zhejiang University
Xinqiao Hospital of Chongqing
The Second Affiliated Hospital of Chongqing Medical University
First Affiliated Hospital of Chongqing Medical University
the Second Affiliated Hospital of Anhui Medical University
The First Affiliated Hospital of Anhui Medical University
General Hospital of Ningxia Medical University
Shengjing Hospital
Information provided by (Responsible Party):
Minghui Zhao, Peking University First Hospital

Brief 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. 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.

Condition or disease Intervention/treatment
Renal Insufficiency, Chronic Other: Demographic factors, biomedical measurements, drugs used for controlling metabolic disorders, etc

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
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chinese Cohort Study of Chronic Kidney Disease
Actual Study Start Date : January 1, 2012
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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

  2. 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.

  3. Death [ Time Frame: from date of baseline examination until the date of death from any cause, up to 60 months ]
    death from any cause


Biospecimen Retention:   Samples With DNA
Blood samples Urine samples DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041987


Contacts
Contact: Fang Wang, MD 011-86-10-83575535 wangfang@bjmu.edu.cn
Contact: Yunfei Bao, MS 011-86-10-83575535 ckdcohort@163.com

Locations
China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Yunfei Bao, MS    011-86-10-83575535    ckdcohort@163.com   
Principal Investigator: Luxia Zhang, MD, MPH         
Sponsors and Collaborators
Peking University First Hospital
Peking University Third Hospital
Dongzhimen Hospital, Beijing
Beijing Hospital
Beijing Boai Hospital
Peking University Shenzhen Hospital
First Affiliated Hospital of Guangxi Medical University
Guizhou Provincial People's Hospital
the Affiliated Hospital of Chengde Medical Colledge
Affiliated Hospital of Hebei University
The Second Hospital of Hebei Medical University
The First Affiliated Hospital of Zhengzhou University
the Affiliated Hospital of Hubei Traditional Chinese Medical College
Xiangya Hospital of Central South University
The First Affiliated Hospital with Nanjing Medical University
The First Affiliated Hospital of Dalian Medical University
Chifeng Second Hospital
The First Affiliated Hospital of BaoTou Medical College
Qilu Hospital of Shandong University
Shandong Provincial Hospital
Qianfoshan Hospital
Second Hospital of Shanxi Medical University
Minhang Central Hospital
West China Hospital
Sichuan Provincial People's Hospital
Tianjin Medical University General Hospital
Tianjin Medical University Second Hospital
the First Affiliated Hospital of the Medical College of Shihezi University
First Affiliated Hospital of Xinjiang Medical University
The Second Affiliated Hospital of Kunming Medical University
Yuxi City People’s Hospital
Zhejiang University
Xinqiao Hospital of Chongqing
The Second Affiliated Hospital of Chongqing Medical University
First Affiliated Hospital of Chongqing Medical University
the Second Affiliated Hospital of Anhui Medical University
The First Affiliated Hospital of Anhui Medical University
General Hospital of Ningxia Medical University
Shengjing Hospital
Investigators
Principal Investigator: Minghui Zhao, MD, Ph.D. Peking University First Hospital

Publications of Results:

Other Publications:
Responsible Party: Minghui Zhao, Director of Renal Division, Department of Medicine, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03041987     History of Changes
Other Study ID Numbers: 2011BAI10B01
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Minghui Zhao, Peking University First Hospital:
Cohort studies
Prognosis

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases