Multimorbidity and Sarcopenia Feasibility Study in Chronic Kidney Disease

NCT06109662 | Active Not Recruiting

• 1 other identifier: 328554
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this research study is to look at the body composition (such as muscle and fat) in people with chronic kidney disease (CKD) and comparing it with body composition is people without CKD. The investigators currently understand loss of muscle function and mass (sarcopenia) affect the general health of people as they age, but this process seems to be more common, accelerated, and occurs earlier in people with CKD. There is limited evidence in this area, and we believe that if we understand when and how sarcopenia affects people with CKD, investigators can guide future trials and treatments to help treat sarcopenia, and in turn improve quality of life and health outcomes in people with CKD.

Conditions

Chronic Kidney Diseases; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Creatinine Muscle Index (mg/day per 1.73m2)

  Product of serum Creatinine and estimated glomerular filtration rate with Cystatin C (eGFRcys)

  Day 1 (day recruited) and at 1 year

Secondary Outcomes (2)

• Skeletal muscle mass (kg)

  At Day 1 (day recruited) and 1 year

• Multimorbidity Score

  Day 1 (day recruited) and 1 year

Study Arms (4)

Healthy volunteers

Normal renal function with no kidney disease. Participants with other comorbidities can be included as long as not listed on the exclusion criteria. They will have body composition measured, and eGFR measured.

Diagnostic Test: Cystatin C eGFR; Other: Bioimpedance Analysis (Body composition analysis)

Chronic Kidney Disease Stage 3

People with CKD Stage 3 (eGFR 30-59). They will have body composition measured, and eGFR measured.

Diagnostic Test: Cystatin C eGFR; Other: Bioimpedance Analysis (Body composition analysis)

Chronic Kidney Disease Stage 4

People with CKD 4 (eGFR 15-29). They will have body composition measured, and eGFR measured.

Diagnostic Test: Cystatin C eGFR; Other: Bioimpedance Analysis (Body composition analysis)

Chronic Kidney Disease Stage 5

People with CKD 5 (eGFR \<15), but not on dialysis. They will have body composition measured, and eGFR measured.

Diagnostic Test: Cystatin C eGFR; Other: Bioimpedance Analysis (Body composition analysis)

Interventions

Cystatin C eGFR DIAGNOSTIC_TEST

Cystatin C eGFR is not used routinely currently in clinical practice in the UK. It involved a blood test to analyse Cystatin C.

Chronic Kidney Disease Stage 3; Chronic Kidney Disease Stage 4; Chronic Kidney Disease Stage 5; Healthy volunteers

Bioimpedance Analysis (Body composition analysis) OTHER

Participants will stand on a bioimpedance analysis machine which will measure different components of body composition

Chronic Kidney Disease Stage 3; Chronic Kidney Disease Stage 4; Chronic Kidney Disease Stage 5; Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

80 participants with different levels of renal function (normal renal function, CKD3,4 and 5) to be recruited from secondary care renal department.

You may qualify if:

• Subjects capable of giving informed consent
• ≥18 years of age Chronic kidney disease stages 3-5 looked after in secondary care nephrology Healthy volunteers with normal kidney function (Control)

You may not qualify if:

• Pregnancy
• Subjects with known neuromuscular diseases, e.g. myopathy, muscular dystrophy, muscular atrophy
• Renal transplant recipients
• Patients with pacemakers

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust: lead

Study Sites (1)

University Hospitals of Derby and Burton NHS Foundation Trust

Derby, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Sarcopenia

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; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 31, 2023
• Study Start: February 12, 2024
• Primary Completion: November 2, 2025
• Study Completion: November 2, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)