End-stage Kidney DiseaseNCT06477978
The Prevalence of Sarcopenia in a Cohort of Haemodialysis Patients and Its Correlation With Mortality
A study testing Hand grip function testing in people with End-stage Kidney Disease and End-stage Renal Disease, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The study aims to explore the correlation between the prevalence of sarcopenia and one year mortality amongst patients on maintenance hemodialysis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End-stage Kidney Disease, End-stage Renal Disease, Dialysis Dependent Chronic Kidney Disease
- What is being tested?
- Hand grip function testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2021to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with End stage kidney disease on maintenance dialysis
Who cannot join
- unable to consent or terminal malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence of Sarcopenia in a Cohort of Patients With End Stage Kidney Disease on Haemodialysis Patients and Its Correlation With Mortality
The study aims to explore the correlation between the prevalence of sarcopenia and one year mortality amongst patients on maintenance hemodialysis
Read the detailed description
In our study , we aim to explore the correlation between the prevalence of sarcopenia and one year mortality among patients on maintenance hemodialysis The lean muscle mass was measured using bio-impedance analysis (BIA ). The hand-grip test was used to measure the function .
Sarcopenia was defined using European Working Group on Sarcopenia in Older people (EWGSOP) definition which involves reduced muscle function and reduced muscle mass
- Conditions
- End-stage Kidney Disease, End-stage Renal Disease, Dialysis Dependent Chronic Kidney Disease, Sarcopenia
- Being tested
- Hand grip function testing
- Keywords
- sarcopenia, end stage renal disease, end stage kidney disease, dialysis dependent end stage renal disease
- Medical subject headings
- Kidney Failure, Chronic, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand grip function testingDiagnostic test
Also called Measuring skeletal body mass using bio-impedance analysis ( BIA)
The use of Bio-impedance to measure the skeletal muscle mass
| Study group | Role | What they receive |
|---|---|---|
| End stage kidney disease patient on maintenance hemodialysis | Other | All patient that have been recruited with have the lean body mass index measured sing the Bio-impedance analysis ( BIA ) Receives: Diagnostic Test: Hand grip function testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
One year mortality
All cause mortality of patients with end stage kidney disease on hemodialysis
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start15 Feb 2021
- Primary completion13 May 2022
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Kidney DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is cohort prospective study of end stage kidney disease patients on hemodialysis
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Samy Abdelaziz, Kasr El Aini Hospital
- Investigators
- Tarek Abdelaziz, PhD, Principal investigator, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477978
- Sponsor's protocol ID
- MD-119-2020
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Sarcopenia in a Cohort of Patients With End Stage Kidney Disease on Haemodialysis Patients and Its Correlation With Mortality
- ClinicalTrials.gov ID
- NCT06477978
- Acronym / sponsor ID
- MD-119-2020
- Conditions
- End-stage Kidney Disease, End-stage Renal Disease, Dialysis Dependent Chronic Kidney Disease, Sarcopenia
- Keywords
- sarcopenia, end stage renal disease, end stage kidney disease, dialysis dependent end stage renal disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 27 Jun 2024 (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 study aims to explore the correlation between the prevalence of sarcopenia and one year mortality amongst patients on maintenance hemodialysis
Detailed description
In our study , we aim to explore the correlation between the prevalence of sarcopenia and one year mortality among patients on maintenance hemodialysis The lean muscle mass was measured using bio-impedance analysis (BIA ). The hand-grip test was used to measure the function .
Sarcopenia was defined using European Working Group on Sarcopenia in Older people (EWGSOP) definition which involves reduced muscle function and reduced muscle mass
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is cohort prospective study of end stage kidney disease patients on hemodialysis
| Arm | Type | Receives |
|---|---|---|
| End stage kidney disease patient on maintenance hemodialysis | Other | Diagnostic Test: Hand grip function testingAll patient that have been recruited with have the lean body mass index measured sing the Bio-impedance analysis ( BIA ) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with End stage kidney disease on maintenance dialysis
Key exclusion criteria (1 listed)
- unable to consent or terminal malignancy
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 |
|---|---|---|
| Hand grip function testingAlso: Measuring skeletal body mass using bio-impedance analysis ( BIA)The use of Bio-impedance to measure the skeletal muscle mass | Diagnostic test | End stage kidney disease patient on maintenance hemodialysis |
Primary outcome
One year mortality
Time frame: One year
All cause mortality of patients with end stage kidney disease on hemodialysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No. Upon reasonable request
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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.
Tarek Abdelaziz, PhD principal investigator
Kasr El Aini Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand grip function testing in people with End-stage Kidney Disease and End-stage Renal Disease, run by Kasr El Aini Hospital at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Jun 2024. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
One year mortality (time frame: One 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 27 Jun 2024.