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Active, Not Recruiting

NCT Number: NCT06109662

Multimorbidity and Sarcopenia Feasibility Study in Chronic Kidney Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Kidney Diseases Atrophy Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Sarcopenia Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of Derby and Burton NHS Foundation Trust

Derby, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Bioimpedance Analysis (Body composition analysis)

Other

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

Primary outcomes

  1. Creatinine Muscle Index (mg/day per 1.73m2)

    Time frame: Day 1 (day recruited) and at 1 year

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

Secondary outcomes

  1. Skeletal muscle mass (kg)

    Time frame: At Day 1 (day recruited) and 1 year

    Measured by Bioimpedance analysis

  2. Multimorbidity Score

    Time frame: Day 1 (day recruited) and 1 year

    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.

Sponsors and collaborators

Lead sponsor

University Hospitals of Derby and Burton NHS Foundation Trust

Other

Registry information

Acronym: MaSS-CKD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 31, 2023
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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