Chronic Kidney DiseasesDISON-IRCNCT04809493
Study Evaluating the Effect of Isonatremic Dialysis Treatment in Chronic Kidney Disease Patients on Dialysis
An observational study of Chronic Kidney Diseases, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (Stage 5D), the effect of treatment with isonatremic dialysis (vs conventional dialysis), during an observational period of 2 months each, on: control of interdialytic weight gain perdialytic tolerance in terms of adverse… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Conventional dialysis treatment and Isonatremic dialysis treatment
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 31 Dec 2022
- Phase
- Observational
- 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
Study population: Patients issued from dialysis units (hospital, clinic, non profit dialysis centers)
Who may be able to join
- Chronic Kidney Disease patient on dialysis (stage 5D)
- With plasma sodium concentration between 130 and 140 mmol/L
- Anuric
- Patient dialysed with dialysis machine allowing isonatremic dialysis treatment
Who cannot join
- Patient with plasma sodium concentration below 130 or above 140 mmol/
- Pacemaker
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34290
Jean Paul Cristol, Prof, 4 67 33 83 15 ext. 33, jp-cristol@chu-montpellier.fr
Jean-Yves BOSC, MD, 430 781 868 ext. 33, j.bosc@aidersante.com
About this study
Official title: Evaluation of the Effect of Isonatremic (vs Conventional) Dialysis Treatment on the Control of Interdialytic Weight Gain in Chronic Kidney Disease Patients on Dialysis (Stage 5D)
Aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (Stage 5D), the effect of treatment with isonatremic dialysis (vs conventional dialysis), during an observational period of 2 months each, on:
- control of interdialytic weight gain
- perdialytic tolerance in terms of adverse events occurring during all of the sessions of the study
- body composition and thirst measured monthly during the 4 months of follow-up.
- tolerance to treatment.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Conventional dialysis treatment, Isonatremic dialysis treatment
- Keywords
- Chronic Kidney Disease patient on dialysis (stage 5D), Extracorporeal purification, Isonatremic dialysis, Sodium
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional dialysis treatmentProcedure or surgery
Conventional dialysis treatment
Isonatremic dialysis treatmentProcedure or surgery
Isonatremic dialysis treatment
| Study group | Role | What they receive |
|---|---|---|
| patients will be receiving conventional dialysis | Patients will be receiving conventional dialysis treatment followed by isonatremic dialysis treatment during an observational period of 2 months for each treatment Receives: Procedure: Conventional dialysis treatment; Procedure: Isonatremic dialysis treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of interdialytic weight gain during treatment
change of interdialytic weight gain during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.
Measured: 1, 2, 3 and 4 months after inclusion
Secondary outcomes (3)
Perdialytic tolerance in terms of adverse events occurring
Perdialytic tolerance in terms of adverse events occurring during all sessions of the study with isonatremic dialysis vs conventional dialysis for an observational period of 2 months each one.
Measured: 1, 2, 3 and 4 months after inclusion
Body composition
Body composition monthly during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.
Measured: 1, 2, 3 and 4 months after inclusion
Rate of Tolerance
Rate of Tolerance during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.
Measured: 1, 2, 3 and 4 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (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.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul CRISTOL, Prof, Study director, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809493
- Sponsor's protocol ID
- RECHMPL20_0659
- Acronym
- DISON-IRC
- Status last verified
- Apr 2022
- First submitted
- 17 Mar 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Isonatremic (vs Conventional) Dialysis Treatment on the Control of Interdialytic Weight Gain in Chronic Kidney Disease Patients on Dialysis (Stage 5D)
- ClinicalTrials.gov ID
- NCT04809493
- Acronym / sponsor ID
- DISON-IRC / RECHMPL20_0659
- Conditions
- Chronic Kidney Diseases
- Keywords
- Chronic Kidney Disease patient on dialysis (stage 5D), Extracorporeal purification, Isonatremic dialysis, Sodium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Mar 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.
Aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (Stage 5D), the effect of treatment with isonatremic dialysis (vs conventional dialysis), during an observational period of 2 months each, on:
- control of interdialytic weight gain
- perdialytic tolerance in terms of adverse events occurring during all of the sessions of the study
- body composition and thirst measured monthly during the 4 months of follow-up.
- tolerance to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients will be receiving conventional dialysis | – | Procedure: Conventional dialysis treatment, Procedure: Isonatremic dialysis treatmentPatients will be receiving conventional dialysis treatment followed by isonatremic dialysis treatment during an observational period of 2 months for each treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients issued from dialysis units (hospital, clinic, non profit dialysis centers)
Key inclusion criteria (4 listed)
- Chronic Kidney Disease patient on dialysis (stage 5D)
- With plasma sodium concentration between 130 and 140 mmol/L
- Anuric
- Patient dialysed with dialysis machine allowing isonatremic dialysis treatment
Key exclusion criteria (2 listed)
- Patient with plasma sodium concentration below 130 or above 140 mmol/
- Pacemaker
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 |
|---|---|---|
| Conventional dialysis treatmentConventional dialysis treatment | Procedure or surgery | patients will be receiving conventional dialysis |
| Isonatremic dialysis treatmentIsonatremic dialysis treatment | Procedure or surgery | patients will be receiving conventional dialysis |
Primary outcome
Change of interdialytic weight gain during treatment
Time frame: 1, 2, 3 and 4 months after inclusion
change of interdialytic weight gain during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.
3 secondary outcomes
Perdialytic tolerance in terms of adverse events occurring
Time frame: 1, 2, 3 and 4 months after inclusion
Body composition
Time frame: 1, 2, 3 and 4 months after inclusion
Rate of Tolerance
Time frame: 1, 2, 3 and 4 months after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
Jean-Paul CRISTOL, Prof study director
UH MONTPELLIER
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, run by University Hospital, Montpellier 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 4 inclusion and 2 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 14 Apr 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 Jean-Paul CRISTOL, Prof (+33(0)4 67 33 83 15, jp-cristol@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of interdialytic weight gain during treatment (time frame: 1, 2, 3 and 4 months after inclusion). 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 14 Apr 2022.