Terminal Renal InsufficiencyEHDXTRQVNCT05689801
Describe the Effect of the Optimized Hemodialysis Technique (HDx) With Medium Cut-Off Membrane on Recovery Time and Quality of Life
A study testing Questionnaire "recovery time after a dialysis session"., SF-12 questionnaire and EQ-5D-5L Questionnaire in people with Terminal Renal Insufficiency, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
In this study, the effect of optimizing the dialytic technique using simple questionnaires carried out in clinical routine will be described. More specifically, the conventional dialysis technique will be combined with biofeedback software called HemoControl™. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Terminal Renal Insufficiency
- What is being tested?
- Questionnaire "recovery time after a dialysis session"., SF-12 questionnaire and EQ-5D-5L Questionnaire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2022to 18 Oct 2024
- 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
- Patient, male or female (using contraceptives, if of childbearing age), over 18 years of age
- Patient on conventional hemodialysis with synthetic membrane for at least 3 months
- Patient with a recovery time after the dialysis session ≥ 4 hours
- Informed patient who has signed a written consent to participate in the study
- Affiliated patient or beneficiary of a social security scheme
Who cannot join
- Patient whose seniority of dialysis is less than 3 months
- Pregnant woman
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Patient with severe cognitive impairment
- Medically unstable or frail patient
- Patient who did not sign an informed consent form accepting this research (refusal of consent or absence of signature).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study: Describe the Effect of the Optimized Hemodialysis Technique (HDx) With Medium Cut-Off Membrane on Recovery Time and Quality of Life
In this study, the effect of optimizing the dialytic technique using simple questionnaires carried out in clinical routine will be described.
More specifically, the conventional dialysis technique will be combined with biofeedback software called HemoControl™. The recovery time and quality of life of patients who will use a polyethersulfone membrane (Revaclear®) and a Medium Cut-Off (MCO) membrane (Theranova®) will be observed.
The main objective is to describe the evolution of recovery time after a dialysis session in conventional hemodialysis (HD) on Revaclear® membrane and in so-called optimized hemodialysis (HDx) on MCO membrane, Theranova®.
- Conditions
- Terminal Renal Insufficiency
- Being tested
- Questionnaire "recovery time after a dialysis session"., SF-12 questionnaire, EQ-5D-5L Questionnaire, Pittman, John et McIntyre questionnaire, Conventional hemodialysis
- Keywords
- terminal renal insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire "recovery time after a dialysis session".Other
A very short questionnaire just after the dialysis session
SF-12 questionnaireOther
Questionnaire about quality of life of the patient
EQ-5D-5L QuestionnaireOther
Questionnaire about quality of life of the patient
Pittman, John et McIntyre questionnaireOther
Questionnaire about quality of life of the patient under dialysis
Conventional hemodialysisProcedure or surgery
patient on polyethersulfone membrane dialysis (Revaclear®, Baxter) with HemoControl™ for 12 weeks
Optimized hemodialysisProcedure or surgery
patient on Medium Cut-Off membrane dialysis (Theranova®, Baxter) with HemoControl™ for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Patient on conventional hemodialysis then on optimized hemodialysis | Experimental | Not described Receives: Other: Questionnaire "recovery time after a dialysis session".; Other: SF-12 questionnaire; Other: EQ-5D-5L Questionnaire; Other: Pittman, John et McIntyre questionnaire; Procedure: Conventional hemodialysis; Procedure: Optimized hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Result of the questionnaire "recovery time after a dialysis session"
only one question : how long time recovering after a dialysis session (hours)
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start14 Dec 2022
- Primary completion13 Jul 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Terminal Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689801
- Sponsor's protocol ID
- 2022-A01511-42
- Acronym
- EHDXTRQV
- Status last verified
- Jul 2026
- First submitted
- 22 Dec 2022
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Describe the Effect of the Optimized Hemodialysis Technique (HDx) With Medium Cut-Off Membrane on Recovery Time and Quality of Life
- ClinicalTrials.gov ID
- NCT05689801
- Acronym / sponsor ID
- EHDXTRQV / 2022-A01511-42
- Conditions
- Terminal Renal Insufficiency
- Keywords
- terminal renal insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 13 Jul 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 19 Jan 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.
In this study, the effect of optimizing the dialytic technique using simple questionnaires carried out in clinical routine will be described.
More specifically, the conventional dialysis technique will be combined with biofeedback software called HemoControl™. The recovery time and quality of life of patients who will use a polyethersulfone membrane (Revaclear®) and a Medium Cut-Off (MCO) membrane (Theranova®) will be observed.
The main objective is to describe the evolution of recovery time after a dialysis session in conventional hemodialysis (HD) on Revaclear® membrane and in so-called optimized hemodialysis (HDx) on MCO membrane, Theranova®.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient on conventional hemodialysis then on optimized hemodialysis | Experimental | Other: Questionnaire "recovery time after a dialysis session"., Other: SF-12 questionnaire, Other: EQ-5D-5L Questionnaire, Other: Pittman, John et McIntyre questionnaire, Procedure: Conventional hemodialysis, Procedure: Optimized hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient, male or female (using contraceptives, if of childbearing age), over 18 years of age
- Patient on conventional hemodialysis with synthetic membrane for at least 3 months
- Patient with a recovery time after the dialysis session ≥ 4 hours
- Informed patient who has signed a written consent to participate in the study
- Affiliated patient or beneficiary of a social security scheme
Key exclusion criteria (6 listed)
- Patient whose seniority of dialysis is less than 3 months
- Pregnant woman
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Patient with severe cognitive impairment
- Medically unstable or frail patient
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 |
|---|---|---|
| Questionnaire "recovery time after a dialysis session".A very short questionnaire just after the dialysis session | Other | Patient on conventional hemodialysis then on optimized hemodialysis |
| SF-12 questionnaireQuestionnaire about quality of life of the patient | Other | Patient on conventional hemodialysis then on optimized hemodialysis |
| EQ-5D-5L QuestionnaireQuestionnaire about quality of life of the patient | Other | Patient on conventional hemodialysis then on optimized hemodialysis |
| Pittman, John et McIntyre questionnaireQuestionnaire about quality of life of the patient under dialysis | Other | Patient on conventional hemodialysis then on optimized hemodialysis |
| Conventional hemodialysispatient on polyethersulfone membrane dialysis (Revaclear®, Baxter) with HemoControl™ for 12 weeks | Procedure or surgery | Patient on conventional hemodialysis then on optimized hemodialysis |
| Optimized hemodialysispatient on Medium Cut-Off membrane dialysis (Theranova®, Baxter) with HemoControl™ for 12 weeks. | Procedure or surgery | Patient on conventional hemodialysis then on optimized hemodialysis |
Primary outcome
Result of the questionnaire "recovery time after a dialysis session"
Time frame: 7 months
only one question : how long time recovering after a dialysis session (hours)
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 16 Jul 2026.
Related trials for Terminal Renal Insufficiency
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
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?
A study testing Questionnaire "recovery time after a dialysis session"., SF-12 questionnaire and EQ-5D-5L Questionnaire in people with Terminal Renal Insufficiency, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 6 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 16 Jul 2026. 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?
Result of the questionnaire "recovery time after a dialysis session" (time frame: 7 months). 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 16 Jul 2026.