Daily Home HemodialysisCIMHBaDDNCT05419271
Controlled Internal Convection in Low Flow Hemodialysis of Dialysate: Removal of Beta-2-microglobulin
A study testing home hemodialysis session with 9L internal convection in people with Daily Home Hemodialysis, run by University Hospital, Caen at 1 site in France.
Trial summary
Since 2013 daily home hemodialysis allows low volumes of convection. This study is a prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Daily Home Hemodialysis
- What is being tested?
- home hemodialysis session with 9L internal convection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 9 May 2022to Sep 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- home hemodialysis since at least 2 weeks
- hemodialysis since at least 3 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Caen Normandie
Caen, 14000
Maxence FICHEUX, ficheux-m@chu-caen.fr
About this study
Since 2013 daily home hemodialysis allows low volumes of convection. This study is a prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis.
Read the detailed description
Daily home hemodialysis with low dialysate volume system does not normally allow convection. Middle molecular weight toxins clearance is therefore lower. Beta2-microglobulin is considered representative of these middle molecules and contributes to the uremic toxic state.
Since 2013 daily home hemodialysis allows low volumes of convection ranging from 0 to 9L per session. This technology is called "push pulls" and uses internal convection.
This study is a prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis.
Intradialytic fall of B2m levels is compared in 16 patients treated by one session of dialysis with 9L internal convection and one usual session with free internal convection.
The Kt/V of urea, the phosphorus and sodium removal, the plasma fall of myoglobin, prolactin, kappa and lambda free light chains, intradialytic fall of orosomucoid will be compared between the two session as secondary objectives.
- Conditions
- Daily Home Hemodialysis
- Being tested
- home hemodialysis session with 9L internal convection
- Keywords
- daily dialysis, home hemodialysis, Middle-molecular weight toxins, Beta2-microglobulin, Push-Pull
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home hemodialysis session with 9L internal convectionProcedure or surgery
home hemodialysis session with 9L internal convection
| Study group | Role | What they receive |
|---|---|---|
| experimental convection | Experimental | session of dialysis with 9L internal convection Receives: Procedure: home hemodialysis session with 9L internal convection |
| free internal convection | No intervention | session of dialysis with free internal convection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Middle molecular weight toxins clearance
Beta2-microglobulin levels
Measured: during hemodialysis procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start9 May 2022
- Primary completionJun 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Daily Home HemodialysisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- A prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis, intradialytic fall of B2m levels is compared in 16 patients treated by one session of dialysis with 9L internal convection and one usual session with free internal convection.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419271
- Sponsor's protocol ID
- 22-0017
- Acronym
- CIMHBaDD
- Status last verified
- May 2022
- First submitted
- 16 May 2022
- Last updated
- 15 Jun 2022
- 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 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Internal Convection in Low Flow Hemodialysis of Dialysate: Removal of Beta-2-microglobulin
- ClinicalTrials.gov ID
- NCT05419271
- Acronym / sponsor ID
- CIMHBaDD / 22-0017
- Conditions
- Daily Home Hemodialysis
- Keywords
- daily dialysis, home hemodialysis, Middle-molecular weight toxins, Beta2-microglobulin, Push-Pull
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 15 Jun 2022 (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.
Since 2013 daily home hemodialysis allows low volumes of convection. This study is a prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis.
Detailed description
Daily home hemodialysis with low dialysate volume system does not normally allow convection. Middle molecular weight toxins clearance is therefore lower. Beta2-microglobulin is considered representative of these middle molecules and contributes to the uremic toxic state.
Since 2013 daily home hemodialysis allows low volumes of convection ranging from 0 to 9L per session. This technology is called "push pulls" and uses internal convection.
This study is a prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis.
Intradialytic fall of B2m levels is compared in 16 patients treated by one session of dialysis with 9L internal convection and one usual session with free internal convection.
The Kt/V of urea, the phosphorus and sodium removal, the plasma fall of myoglobin, prolactin, kappa and lambda free light chains, intradialytic fall of orosomucoid will be compared between the two session as secondary objectives.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis, intradialytic fall of B2m levels is compared in 16 patients treated by one session of dialysis with 9L internal convection and one usual session with free internal convection.
| Arm | Type | Receives |
|---|---|---|
| experimental convection | Experimental | Procedure: home hemodialysis session with 9L internal convectionsession of dialysis with 9L internal convection |
| free internal convection | No intervention | –session of dialysis with free internal convection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- home hemodialysis since at least 2 weeks
- hemodialysis since at least 3 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| home hemodialysis session with 9L internal convectionhome hemodialysis session with 9L internal convection | Procedure or surgery | experimental convection |
Primary outcome
Middle molecular weight toxins clearance
Time frame: during hemodialysis procedure
Beta2-microglobulin levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home hemodialysis session with 9L internal convection in people with Daily Home Hemodialysis, run by University Hospital, Caen 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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 15 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maxence FICHEUX (0231063106, ficheux-m@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Middle molecular weight toxins clearance (time frame: during hemodialysis procedure). 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 15 Jun 2022.