Strategies for Proactive Health in People With Kidney Function Decline

NCT07245186 | Enrolling By Invitation

• 1 other identifier: KY2023-973
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Insufficiency,Chronic; Dietary Intake Patterns; Malnutrition; Frailty; Cognitive Dysfunction; CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder

Keywords

Kidney Function Decline; Nutritional Intake; Dietary Assessment; Health Outcomes; Cohort Study

Outcome Measures

Primary Outcomes (1)

• Rapid decline in renal function

  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.

  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 Outcomes (6)

• End-Stage Renal Disease (ESRD)

  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

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

• All-Cause Mortality

  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

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

• Frailty

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

Study Arms (1)

Patients with renal function decline (non-dialysis cohort)

This is a multi-center prospective cohort study led by Huashan Hospital, Fudan University, with collaboration from several other hospitals. The study aims to recruit at least1800 participants, primarily older adults, with varying degrees of kidney function decline, with enrollment ongoing from January 2021 to December 2029. Participants undergo baseline assessments, including dietary intake surveys, biochemical and metabolic testing, body composition analysis, and clinical evaluations. Follow-up assessments are conducted at predetermined intervals to monitor kidney function, cardiovascular health, metabolic status, and overall well-being. This cohort provides a structured platform for long-term observational research on the relationship between nutrition, metabolism, and health outcomes in aging populations. The findings will support the development of precision nutrition strategies and proactive aging health management.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 years or older with reduced kidney function (eGFR \< 90 mL/min/1.73 m²) who are not receiving dialysis. Participants are recruited from outpatient clinics at Huashan Hospital, Fudan University.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Huashan hospital, Fudan university

Shanghai, Shanghai Municipality, 20040, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Malnutrition; Frailty; Cognitive Dysfunction; Chronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Jing Chen, PhD, MD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 24, 2025
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)