Strategies for Proactive Health in People With Kidney Function Decline
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Renal Insufficiency,Chronic, Dietary Intake Patterns, Malnutrition, Frailty. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exploring Approaches for Proactive Health in People With Kidney Function Decline: Insights From a Prospective Cohort Study
Overview
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.
Detailed description
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.
Primary outcome measures
- 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.]
Secondary outcome measures (6)
- 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).]
- Incidence of Cardiovascular Events [Time frame: Evaluated at baseline, at 6 months, at 1 year, and annually thereafter up to 10 years.]
- 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).]
- Cognitive Impairment [Time frame: Evaluated at baseline, 12 months, 24 months, 36 months, and every 2 years thereafter up to 10 years.]
- Frailty [Time frame: Measured at baseline, 12 months, 24 months, 36 months, and every 2 years thereafter up to 10 years.]
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Huashan hospital, Fudan university — Shanghai
Identifiers
NCT: NCT07245186 · KY2023-973