--- title: Strategies for Proactive Health in People With Kidney Function Decline nct_id: NCT07245186 overall_status: ENROLLING_BY_INVITATION sponsor: Huashan Hospital study_type: OBSERVATIONAL primary_condition: Renal Insufficiency,Chronic countries: China canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07245186.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07245186" ct_last_update_post_date: 2025-11-24 last_seen_at: "2026-05-12T06:18:24.685Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Strategies for Proactive Health in People With Kidney Function Decline **Official Title:** Exploring Approaches for Proactive Health in People With Kidney Function Decline: Insights From a Prospective Cohort Study **NCT ID:** [NCT07245186](https://clinicaltrials.gov/study/NCT07245186) ## Key Facts - **Status:** ENROLLING_BY_INVITATION - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 1800 - **Lead Sponsor:** Huashan Hospital - **Collaborators:** Jingan District Central Hospital of Shanghai (Jingan Branch of Huashan Hospital Affiliated to Fudan University), Shanghai Changfeng community Healthcare center, Putuo, Shanghai, China - **Conditions:** Renal Insufficiency,Chronic, Dietary Intake Patterns, Malnutrition, Frailty, Cognitive Dysfunction, CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder - **Start Date:** 2021-01-01 - **Completion Date:** 2029-12-30 - **CT.gov Last Update:** 2025-11-24 ## 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. ## 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. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 90 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: 1. Non-dialysis patients with chronic kidney disease (CKD) stages 1-5. 2. Aged 18 to 90 years, no restriction on gender. 3. Sufficient health literacy or a family member with adequate literacy to comply with dietary diary recording and other study procedures. 4. Stable primary disease of CKD at the time of enrollment. Exclusion Criteria: 1. Patients with malignancies, severe cardiovascular diseases, osteoporosis, or severe hematological disorders. 2. Active infections (CRP \>10 mg/L) or current use of nephrotoxic drugs. 3. Limb paralysis or amputation. 4. Use of immunosuppressants (cyclosporine, tacrolimus) within the past 3 months or steroid therapy equivalent to prednisone \>10 mg/day. 5. Severe gastrointestinal diseases affecting nutrient absorption. 6. Participation in other diet- or drug-related clinical studies within the past month or ongoing. 7. Any other condition deemed inappropriate for participation by the investigators. ``` ## Arms - **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. ## Primary Outcomes - **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 - **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.)_ ## Locations (1) - Huashan hospital, Fudan university, Shanghai, Shanghai Municipality, China ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.huashan hospital, fudan university|shanghai|shanghai municipality|china` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT07245186.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT07245186* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*