End Stage Renal DiseaseEASYNCT04824885
Study of a Dialysate Without Acetate on Protein Energy Wasting Syndrome in Chronic Hemodialysis Patient (EASY)
A study testing Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device) in people with End Stage Renal Disease and Hemodialysis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
This work aims to study the effect of an acetate-free dialysate on protein-energy wasting syndrome in patients with chronic hemodialysis renal failure, in comparison to a conventional dialysate with acetate. The hypothesis is that a dialysate without acetate would improve patients nutritional status Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Hemodialysis
- What is being tested?
- Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2022to 6 Mar 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patient;
- Man or woman ;
- Treated with intermittent hemodialysis for chronic renal failure;
- Affiliated with a social security scheme;
- Having given a signed agreement after detailed explanation of the protocol on the basis of the information sheet and likely to comply with it
Who cannot join
- Patient with lower limb amputation more proximal than a transmetatarsal amputation (invalidity of the model for estimating body composition by BCM in this situation)
- Acute event in the 3 months preceding inclusion (infection, surgery).
- Having a neuromuscular pathology responsible for a motor deficit.
- Whose life expectancy does not exceed 6 months
- With a psychiatric pathology or cognitive impairment rendering him unable to give informed consent
- Pregnant women
- Patient under guardianship, curatorship or legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of a Dialysate Without Acetate on Protein Energy Wasting Syndrome in Chronic Hemodialysis Patient
This work aims to study the effect of an acetate-free dialysate on protein-energy wasting syndrome in patients with chronic hemodialysis renal failure, in comparison to a conventional dialysate with acetate. The hypothesis is that a dialysate without acetate would improve patients nutritional status
Read the detailed description
The dialysate usually used at the Clermont Ferrand CHU dialysis center is a dialysate containing acetate After inclusion, patients will be randomly divided into two groups. Patients in group 1 will first be treated with the acetate-free dialysate (A-D) for 6 months and then the acetate-containing dialysate (A + D) for 6 months. Group 2 patients will continue on the usual dialysate (A + D) for 6 months and then switch to A-D dialysate for the next 6 months. Patients will be blinded from study treatment.
Patients will be followed for 1 year.
A the beginning then every 3 months will be carried out:
- A measurement of body composition by multi-frequency bioimpedancemetry
- A measurement of the gripping force by a dynamometer (hand grip force )
- A 4-meter walk test
- A SARC-F Sarcopenia Assessment Questionnaire A blood test for the usual biological analyzes carried out as part of the recommendations for monitoring patients on hemodialysis will be carried out every month.
An additional blood sample (5.5 mL) for quantification of the levels of expression of potential blood biomarkers of muscle condition will be taken initially, at 6 months and at 12 months (i.e. 16.5 mL more compared to current practice). ).
- Conditions
- End Stage Renal Disease, Hemodialysis
- Being tested
- Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device)
- Keywords
- Acetate free dialysate, hemodialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device)Device
usual dialysate (A + D) for 6 months and then switch to A-D dialysate for the next 6 months
| Study group | Role | What they receive |
|---|---|---|
| Acetate free then acetate containing dialysate | Experimental | Patients in group 1 will first be treated with the acetate-free dialysate (A-D) for 6 months and then the acetate-containing dialysate (A + D) for 6 months. Receives: Device: Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device) |
| Acetate containing dialysate then acetate free dialysate | Experimental | Group 2 patients will continue on the usual dialysate (A + D) for 6 months and then switch to A-D dialysate for the next 6 months. Patients will be blinded from study treatment. Receives: Device: Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
prealbumin
biochemical measurement
Measured: change at 6 months from the start of Acetate free or acetate containing dialysate
Secondary outcomes (8)
Muscle mass
Lean Tissue Index or LTI from the spectral analysis of body bioimpedance according to the model of Chamney et al, creatine index according Desmeules et al
Measured: change at 6 months from the start of acetate free or acetate containing dialysate
Muscle performance
meter walk test
Measured: change at 6 months from the start of acetate free or acetate containing dialysate
Muscle performance with hand grip test
hand grip test
Measured: change at 6 months from the start of acetate free or acetate containing dialysate
SARC-F
Result of SARC-F survey
Measured: change at 6 months from the start of acetate free or acetate containing dialysate
muscle biomarkers
blood RNA
Measured: Month 6
muscle biomarkers
blood RNA
Measured: Year 1
mortality
Time to death
Measured: Year 1
morbidity
Time to cardiovascular events
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start15 Feb 2022
- Primary completion6 Mar 2025
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- INRAE
- Responsible party
- Sponsor
- Investigators
- Julien Aniort, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824885
- Sponsor's protocol ID
- AOI 2019 ANIORT
- Other IDs
- 2020-A00678-31
- Acronym
- EASY
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2021
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a Dialysate Without Acetate on Protein Energy Wasting Syndrome in Chronic Hemodialysis Patient
- ClinicalTrials.gov ID
- NCT04824885
- Acronym / sponsor ID
- EASY / AOI 2019 ANIORT
- Conditions
- End Stage Renal Disease, Hemodialysis
- Keywords
- Acetate free dialysate, hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- INRAE
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 1 Apr 2021 (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.
This work aims to study the effect of an acetate-free dialysate on protein-energy wasting syndrome in patients with chronic hemodialysis renal failure, in comparison to a conventional dialysate with acetate. The hypothesis is that a dialysate without acetate would improve patients nutritional status
Detailed description
The dialysate usually used at the Clermont Ferrand CHU dialysis center is a dialysate containing acetate After inclusion, patients will be randomly divided into two groups. Patients in group 1 will first be treated with the acetate-free dialysate (A-D) for 6 months and then the acetate-containing dialysate (A + D) for 6 months. Group 2 patients will continue on the usual dialysate (A + D) for 6 months and then switch to A-D dialysate for the next 6 months. Patients will be blinded from study treatment.
Patients will be followed for 1 year.
A the beginning then every 3 months will be carried out:
- A measurement of body composition by multi-frequency bioimpedancemetry
- A measurement of the gripping force by a dynamometer (hand grip force )
- A 4-meter walk test
- A SARC-F Sarcopenia Assessment Questionnaire A blood test for the usual biological analyzes carried out as part of the recommendations for monitoring patients on hemodialysis will be carried out every month.
An additional blood sample (5.5 mL) for quantification of the levels of expression of potential blood biomarkers of muscle condition will be taken initially, at 6 months and at 12 months (i.e. 16.5 mL more compared to current practice). ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetate free then acetate containing dialysate | Experimental | Device: Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device)Patients in group 1 will first be treated with the acetate-free dialysate (A-D) for 6 months and then the acetate-containing dialysate (A + D) for 6 months. |
| Acetate containing dialysate then acetate free dialysate | Experimental | Device: Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device)Group 2 patients will continue on the usual dialysate (A + D) for 6 months and then switch to A-D dialysate for the next 6 months. Patients will be blinded from study treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Major patient;
- Man or woman ;
- Treated with intermittent hemodialysis for chronic renal failure;
- Affiliated with a social security scheme;
- Having given a signed agreement after detailed explanation of the protocol on the basis of the information sheet and likely to comply with it
Key exclusion criteria (7 listed)
- Patient with lower limb amputation more proximal than a transmetatarsal amputation (invalidity of the model for estimating body composition by BCM in this situation)
- Acute event in the 3 months preceding inclusion (infection, surgery).
- Having a neuromuscular pathology responsible for a motor deficit.
- Whose life expectancy does not exceed 6 months
- With a psychiatric pathology or cognitive impairment rendering him unable to give informed consent
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 |
|---|---|---|
| Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device)usual dialysate (A + D) for 6 months and then switch to A-D dialysate for the next 6 months | Device | Acetate containing dialysate then acetate free dialysate, Acetate free then acetate containing dialysate |
Primary outcome
prealbumin
Time frame: change at 6 months from the start of Acetate free or acetate containing dialysate
biochemical measurement
8 secondary outcomes
Muscle mass
Time frame: change at 6 months from the start of acetate free or acetate containing dialysate
Muscle performance
Time frame: change at 6 months from the start of acetate free or acetate containing dialysate
Muscle performance with hand grip test
Time frame: change at 6 months from the start of acetate free or acetate containing dialysate
SARC-F
Time frame: change at 6 months from the start of acetate free or acetate containing dialysate
muscle biomarkers
Time frame: Month 6
muscle biomarkers
Time frame: Year 1
mortality
Time frame: Year 1
morbidity
Time frame: Year 1
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 12 Mar 2025.
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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.
Julien Aniort principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device) in people with End Stage Renal Disease and Hemodialysis, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 5 inclusion and 7 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 12 Mar 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 France. 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?
prealbumin (time frame: change at 6 months from the start of Acetate free or acetate containing dialysate). 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 12 Mar 2025.