Multimorbidity and Sarcopenia Feasibility Study in Chronic Kidney Disease (MaSS-CKD)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Kidney Diseases; Sarcopenia
• Intervention / Treatment: Diagnostic test: Cystatin C eGFR; Other: Bioimpedance Analysis (Body composition analysis)

Detailed Description

In this study, the investigators will follow up people with CKD in two visits a year apart. In both visits, the investigators will measure the participants body composition and estimated kidney function using 2 different testing methods - Cystatin C eGFR and Creatinine eGFR. Using both the results in a formula, the creatinine muscle index can be calculated. If this index correlated with sarcopenia, it will be helpful tool in the care of people with CKD as will be a easy to use screening tool for sarcopenia in this population.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

Study Locations

• United Kingdom
  • Derby, United Kingdom
    • University Hospitals of Derby and Burton NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Cystatin C eGFR is not used routinely currently in clinical practice in the UK. It involved a blood test to analyse Cystatin C.; Other: Bioimpedance Analysis (Body composition analysis); Participants will stand on a bioimpedance analysis machine which will measure different components of body composition
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; Cystatin C eGFR is not used routinely currently in clinical practice in the UK. It involved a blood test to analyse Cystatin C.; Other: Bioimpedance Analysis (Body composition analysis); Participants will stand on a bioimpedance analysis machine which will measure different components of body composition
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; Cystatin C eGFR is not used routinely currently in clinical practice in the UK. It involved a blood test to analyse Cystatin C.; Other: Bioimpedance Analysis (Body composition analysis); Participants will stand on a bioimpedance analysis machine which will measure different components of body composition
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; Cystatin C eGFR is not used routinely currently in clinical practice in the UK. It involved a blood test to analyse Cystatin C.; Other: Bioimpedance Analysis (Body composition analysis); Participants will stand on a bioimpedance analysis machine which will measure different components of body composition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal muscle mass (kg)	Measured by Bioimpedance analysis	At Day 1 (day recruited) and 1 year
Multimorbidity Score	The Cambridge Multimorbidity Score is a UK validated index to score the comorbidities of participants. One can score from 0 to 20 on this index. Higher scores are associated with worse clinical outcomes.	Day 1 (day recruited) and 1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Estimated): November 2, 2025
• Study Completion (Estimated): November 2, 2025

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Male Urogenital Diseases; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sarcopenia; Renal Insufficiency, Chronic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Cysteine Proteinase Inhibitors; Cystatins
• Other Study ID Numbers: 328554

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No