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NCT Number: NCT05188885

A Real World, Multi-centric, Observational Registry Study of Chronic Kidney Diseases

Chronic kidney disease (CKD) refers to a variety of different diseases characterized by impairment of kidney structure and/or renal function. The prevalence of CKD in China is as high as 10.8%. With a population of more than 150 million, China has the largest number of CKD patients all over the world. People with CKD would not only progress to uremia and need renal replace treatment, it also significantly increases risk of cardiovascular disease than non-CKD population. It has created a heavy burden on people's health and national economy. There is an urgent need to establish an effective system for CKD prevention and control in China. Evidences from large sample cohort and real world based research are still rare. This study will provide good experience for reducing the occurrence and development of CKD.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second People's Hospital of Nanhai District in Foshan City, Foshan, Guangdong, China

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About this study

This study is designed as an investigator-initiated, multi-center, prospective and observational real world study based on mainland Chinese population. The investigators aimed to investigate the occurrence, development, treatment, prognosis state and related risk factors of CKD in China.

This study based on the standardized data network, which provides efficient data collection, integration and analysis for researchers and clinicians in multi-centers.

The sample size of this study was estimated by statisticians, epidemiologists and clinicians. Real-world studies adopted an open standard for inclusion and exclusion, larger sample size could cover a wider group of patients and take the possibility of loss of follow-up into account. Subgroup analysis can be performed in a heterogeneous population and expand the significance of the study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with CKD as defined in the KDIGO Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease 2012 Edition;
  • Non-CKD patients with hypertension, diabetes, hyperlipidemia, hyperuricemia, eGFR (CKD-EPI formula) of 60-89 ml/min/1.73m^2 and other risk factors for CKD;
  • Healthy population.
  • Signed the informed consent voluntarily.

Exclusion criteria

。Patients identified to be unsuitable for enrollment by the study physician.

Treatment and study plan

Primary outcomes

  1. The occurrence of chronic kidney diseases in non-CKD participants

    Time frame: up to 5 years

    The occurrence of chronic kidney disease is defined by KDIGO (Kidney Disease: Improving Global Outcomes) in 2012.

  2. The progression of chronic kidney diseases in CKD participants

    Time frame: up to 5 years

    The progression of chronic kidney disease is defined as: Patients with baseline estimated glomerular filtration rate (eGFR) ≥60 ml /min/1.73m2 had an eGFR decrease of 30% or more, and decreased to <60 ml /min/1.73m2; Or a 50% or greater decrease in baseline eGFR <60 ml /min/1.73m2; Or end-stage renal disease (eGFR <15 ml /min/1.73m2, or initiation of renal replacement therapy)

Secondary outcomes

  1. Progression in albuminuria

    Time frame: up to 5 years

    Progression in albuminuria: Patients with baseline urinary albumin to creatinine Ratio (uACR) <30 mg/g had uACR doubled and increased to ≥30 mg/g; or patients with baseline uACR <300 mg/g had a doubling of uACR and an increase to ≥300 mg/g.

  2. New onset of albuminuria

    Time frame: up to 5 years

    Onset of albuminuria: Patients with baseline uACR <30 mg/g increased to ≥30 mg/g.

  3. New onset of macroalbuminuria

    Time frame: up to 5 years

    Onset of macroalbuminuria: Patients with baseline uACR <300 mg/g increased to ≥300 mg/g.

  4. Composite endpoints of progression of chronic kidney disease and progression of albuminuria

    Time frame: up to 5 years

    Composite endpoints of progression of chronic kidney disease and progression of albuminuria.

  5. Composite endpoint of progression of chronic kidney disease, progression of albuminuria, and all-cause death.

    Time frame: up to 5 years

    Composite endpoint of progression of chronic kidney disease, progression of albuminuria, and all-cause death.

  6. Change of estimated eGFR

    Time frame: up to 5 years

    Change rate per year.

  7. change of uACR

    Time frame: up to 5 years

    Change rate per year.

  8. Rapid decrease of renal function

    Time frame: up to 5 years

    The annual decrease rate of eGFR was > 5mL/min/1.73m2.

Other outcomes

  1. The occurrence and development of complications of chronic renal disease

    Time frame: up to 5 years

    Renal anemia, renal hypertension, mineral bone metabolism disorders, etc.

  2. Rate of Participants with cardiovascular events.

    Time frame: up to 5 years

    Rate of Participants with cardiovascular events.

  3. Rate of Participants with cerebrovascular events.

    Time frame: up to 5 years

    Rate of Participants with cerebrovascular events.

  4. All causes mortality

    Time frame: up to 5 years

    All causes mortality.

  5. Rate of Participants with hospitalization.

    Time frame: up to 5 years

    Rate of Participants with hospitalization.

  6. Changes in cognitive function score.

    Time frame: up to 5 years

    Changes in cognitive function score by questionnaire.

  7. Rate of Participants with new-onset diabetes

    Time frame: up to 5 years

    Rate of Participants with new-onset diabetes.

  8. Rate of Participants with severe infection

    Time frame: up to 5 years

    Rate of Participants with infections that need intravenous injections or hospitalization.

  9. Rate of Participants with bone fracture

    Time frame: up to 5 years

    Rate of Participants with bone fracture.

  10. Rate of Participants with tumor

    Time frame: up to 5 years

    Rate of Participants with tumors.

  11. Rate of Participants with malnutrition

    Time frame: up to 5 years

    A decrease of body weight more than 15%, and/or serum albumin decreased to less than 30 g/L.

  12. Rate of Participants with pregnancy

    Time frame: up to 5 years

    Rate of Participants with pregnancy and birth

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Wen, MD

CONTACT

[email protected]

+86-20-83827812

Xueqing Yu, MD

CONTACT

[email protected]

+86-20-83827812

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2028
First posted
Jan 12, 2022
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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