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Enrolling by Invitation

NCT Number: NCT07245186

Strategies for Proactive Health in People With Kidney Function Decline

This prospective cohort study aims to investigate how kidney function decline affects multiple body systems and how personalized nutrition can help maintain health and slow disease progression. About 1,800 adults with reduced kidney function but not on dialysis will be followed over time at Huashan Hospital, Fudan University. The study will collect information on nutrition, heart and bone health, cognition, and daily functioning through hospital records and a patient mobile app. The goal is to understand the links between nutrition, metabolism, and organ function, and to develop integrated strategies for early prevention and management of chronic kidney disease.

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Key information

Conditions

Renal Insufficiency,Chronic Avitaminosis Bone Diseases Bone Diseases, Metabolic CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder Calcium Metabolism Disorders Chronic Disease Chronic Kidney Disease-Mineral and Bone Disorder Cognition Disorders Cognitive Dysfunction Deficiency Diseases Dietary Intake Patterns Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Frailty Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Male Urogenital Diseases Malnutrition Mental Disorders Metabolic Diseases Musculoskeletal Diseases Neurocognitive Disorders Nutrition Disorders Nutritional and Metabolic Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Rickets Urogenital Diseases Urologic Diseases Vitamin D Deficiency

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Huashan hospital, Fudan university

Shanghai, Shanghai Municipality, 20040, China

About this study

Kidney function often declines gradually with age or chronic conditions, even before chronic kidney disease is formally diagnosed. This decline can disturb the body's overall balance, leading to changes in heart and blood vessel health, bone metabolism, muscle strength, and cognitive performance. Nutrition and metabolism play central roles in these processes, but how they interact during kidney function decline remains unclear.

This prospective cohort study, conducted at Huashan Hospital, Fudan University, aims to understand the multisystem changes that occur during kidney function decline and to explore how individualized, nutrition-integrated management can help maintain health and slow disease progression. Approximately 1,800 adults with an estimated glomerular filtration rate (eGFR) below 90 mL/min/1.73 m² and not receiving dialysis will be enrolled and followed for up to ten years.

Comprehensive information on participants' diet, biochemical markers, heart and bone health, cognition, and physical function will be collected through hospital systems and a mobile nutrition management app. The study seeks to identify how nutritional status and metabolic adaptation relate to outcomes such as kidney function decline, cardiovascular disease, frailty, and cognitive impairment. Findings from this research will help develop an integrated, multidisciplinary approach to prevent complications and improve the overall health and quality of life of people with reduced kidney function.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Non-dialysis patients with chronic kidney disease (CKD) stages 1-5.
  • Aged 18 to 90 years, no restriction on gender.
  • Sufficient health literacy or a family member with adequate literacy to comply with dietary diary recording and other study procedures.
  • Stable primary disease of CKD at the time of enrollment.

Exclusion criteria

  • Patients with malignancies, severe cardiovascular diseases, osteoporosis, or severe hematological disorders.
  • Active infections (CRP >10 mg/L) or current use of nephrotoxic drugs.
  • Limb paralysis or amputation.
  • Use of immunosuppressants (cyclosporine, tacrolimus) within the past 3 months or steroid therapy equivalent to prednisone >10 mg/day.
  • Severe gastrointestinal diseases affecting nutrient absorption.
  • Participation in other diet- or drug-related clinical studies within the past month or ongoing.
  • Any other condition deemed inappropriate for participation by the investigators.

Treatment and study plan

Primary outcomes

  1. Rapid decline in renal function

    Time frame: eGFR will be measured at baseline and at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, and 36 months after enrollment, and subsequently every 6 months thereafter up to 10 years of follow-up.

    The primary outcome is the occurrence of a rapid decline in kidney function, defined as a ≥40% decrease in estimated glomerular filtration rate (eGFR) from baseline during the follow-up period. eGFR will be calculated using the CKD-EPI formula based on serum creatinine measurements obtained during scheduled clinical visits.

Secondary outcomes

  1. End-Stage Renal Disease (ESRD)

    Time frame: Assessed at baseline and every follow-up visit (1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, 36 months, and every 6 months thereafter up to 10 years).

    The occurrence of end-stage renal disease (ESRD), defined as initiation of renal replacement therapy, including maintenance dialysis (hemodialysis or peritoneal dialysis) or receipt of kidney transplantation. ESRD events will be confirmed through clinical records and verified by treating nephrologists.

  2. Incidence of Cardiovascular Events

    Time frame: Evaluated at baseline, at 6 months, at 1 year, and annually thereafter up to 10 years.

    Composite incidence of cardiovascular and cerebrovascular events, including coronary artery disease, cardiac arrhythmia, stroke, heart failure, and sudden cardiac death. All events will be confirmed through medical records, imaging examinations, and classified according to international diagnostic standards.

  3. All-Cause Mortality

    Time frame: Assessed at baseline and every follow-up visit (1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, 36 months, and every 6 months thereafter up to 10 years).

    All-cause mortality includes death due to any cause, with a specific focus on deaths related to kidney disease progression and its complications, particularly cardiovascular disease, infections, and other related conditions. Deaths will be verified through medical records and official documentation.

  4. Cognitive Impairment

    Time frame: Evaluated at baseline, 12 months, 24 months, 36 months, and every 2 years thereafter up to 10 years.

    Cognitive function will be assessed using the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA). MMSE scores <27 and MoCA scores <26 indicate cognitive impairment. Severity will be classified as mild, moderate, or severe based on standardized score ranges and adjusted for education level.

  5. Frailty

    Time frame: Measured at baseline, 12 months, 24 months, 36 months, and every 2 years thereafter up to 10 years.

    Frailty will be determined using the Fried frailty phenotype, defined by the presence of three or more of the following criteria: unintentional weight loss (≥4.5 kg or ≥5% within one year), self-reported exhaustion, weakness (grip strength adjusted for sex and BMI), slow walking speed (adjusted for sex and height), and low physical activity level assessed by the Minnesota Leisure Time Activity Questionnaire.

  6. Malnutrition and Protein-Energy Wasting (PEW)

    Time frame: Assessed at baseline, 6 months, 12 months, 24 months, 36 months, and every 12 months thereafter up to 10 years.

    Nutritional status will be evaluated according to both the GLIM criteria and the ISRNM definition of protein-energy wasting (PEW). GLIM diagnosis requires at least one phenotypic criterion (unintentional weight loss, low BMI, or reduced muscle mass by BIA or ultrasound) and one etiologic criterion (reduced food intake/absorption or disease burden/inflammation). PEW is defined by abnormalities in at least three of four domains: biochemical markers, body composition, muscle mass, and dietary intake, according to ISRNM standards.

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Collaborators

  • Jingan District Central Hospital of Shanghai (Jingan Branch of Huashan Hospital Affiliated to Fudan University)
  • Shanghai Changfeng community Healthcare center, Putuo, Shanghai, China

Registry information

Official study title

Exploring Approaches for Proactive Health in People With Kidney Function Decline: Insights From a Prospective Cohort Study

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

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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