Chronic Kidney DiseasesMaSS-CKDNCT06109662
Multimorbidity and Sarcopenia Feasibility Study in Chronic Kidney Disease
An observational study of Chronic Kidney Diseases and Sarcopenia, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Sarcopenia
- What is being tested?
- Cystatin C eGFR and Bioimpedance Analysis (Body composition analysis)
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Feb 2024to 2 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Pregnancy
- Subjects with known neuromuscular diseases, e.g. myopathy, muscular dystrophy, muscular atrophy
- Renal transplant recipients
- Patients with pacemakers
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Derby and Burton NHS Foundation Trust
Derby
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases, Sarcopenia
- Being tested
- Cystatin C eGFR, Bioimpedance Analysis (Body composition analysis)
- Medical subject headings
- Renal Insufficiency, Chronic, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cystatin C eGFRDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Cystatin C eGFR; Other: Bioimpedance Analysis (Body composition analysis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinine Muscle Index (mg/day per 1.73m2)
Product of serum Creatinine and estimated glomerular filtration rate with Cystatin C (eGFRcys)
Measured: Day 1 (day recruited) and at 1 year
Secondary outcomes (2)
Skeletal muscle mass (kg)
Measured by Bioimpedance analysis
Measured: 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.
Measured: Day 1 (day recruited) and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start12 Feb 2024
- Primary completion2 Nov 2025 (estimated)
- Study completion2 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109662
- Sponsor's protocol ID
- 328554
- Acronym
- MaSS-CKD
- Status last verified
- Jun 2025
- First submitted
- 13 Oct 2023
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimorbidity and Sarcopenia Feasibility Study in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06109662
- Acronym / sponsor ID
- MaSS-CKD / 328554
- Conditions
- Chronic Kidney Diseases, Sarcopenia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 2 Nov 2025 (estimated)
- Study completion
- 2 Nov 2025 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Diagnostic Test: Cystatin C eGFR, Other: Bioimpedance Analysis (Body composition analysis)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. |
| Chronic Kidney Disease Stage 3 | – | Diagnostic Test: Cystatin C eGFR, Other: Bioimpedance Analysis (Body composition analysis)People with CKD Stage 3 (eGFR 30-59). They will have body composition measured, and eGFR measured. |
| Chronic Kidney Disease Stage 4 | – | Diagnostic Test: Cystatin C eGFR, Other: Bioimpedance Analysis (Body composition analysis)People with CKD 4 (eGFR 15-29). They will have body composition measured, and eGFR measured. |
| Chronic Kidney Disease Stage 5 | – | Diagnostic Test: Cystatin C eGFR, Other: Bioimpedance Analysis (Body composition analysis)People with CKD 5 (eGFR <15), but not on dialysis. They will have body composition measured, and eGFR measured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- Pregnancy
- Subjects with known neuromuscular diseases, e.g. myopathy, muscular dystrophy, muscular atrophy
- Renal transplant recipients
- Patients with pacemakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cystatin C eGFRCystatin C eGFR is not used routinely currently in clinical practice in the UK. It involved a blood test to analyse Cystatin C. | Diagnostic test | Chronic Kidney Disease Stage 3, Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 5, Healthy volunteers |
| Bioimpedance Analysis (Body composition analysis)Participants will stand on a bioimpedance analysis machine which will measure different components of body composition | Other | Chronic Kidney Disease Stage 3, Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 5, Healthy volunteers |
Primary outcome
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)
2 secondary outcomes
Skeletal muscle mass (kg)
Time frame: At Day 1 (day recruited) and 1 year
Multimorbidity Score
Time frame: Day 1 (day recruited) and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Diseases
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Sarcopenia, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creatinine Muscle Index (mg/day per 1.73m2) (time frame: Day 1 (day recruited) and at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.