End Stage Renal DiseaseSODIAHNCT06341452
Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis
A study of End Stage Renal Disease, run by Fresenius Medical Care Deutschland GmbH at 1 site in Czechia.
Trial summary
The SODIAH study is designed with the aim to assess the impact of isonatremic dialysis on interdialytic weight gain, fluid status, intradialytic hemodynamic stability, and incidence of intradialytic morbid events in dialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteCzechia
- Study dates
- 16 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- General:
- Informed consent signed and dated by study patient and authorized physician
- Minimum age of 18 years
- The patient is legally competent and able to understand the nature, risks, meaning, and consequences of the clinical trial and can subsequently declare her/his consent for participation in the clinical trial
- Patients with a chronic kidney disease stage 5D (end stage renal disease with a glomerular filtration rate of 15 ml/min or less) on dialysis as extracorporeal renal replacement therapy.
- Study-specific:
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- Patients on dialysis (HD/HDF), at least 4h treatment time thrice weekly ≥ 3 months using a standard dialysate with a prescribed sodium concentration of 136 mmol/L
- Anuric patients (<300mL/d; 1 measurement within last 4 weeks)
- Patient fulfils one of the four following criteria:
- interdialytic weight gain over 4% of dry weight (mean value during run-in period) OR pre-dialytic systolic blood pressure over 180 mmHg (mean value during run-in period) OR intradialytic morbid events (hypotension, hypertension, cramps, headache) in at least three sessions during run-in period OR volume overload according to BCM (FO ≥2.5 L pre-dialysis or relative FO pre-dialysis ≥15% for men and ≥13% for women; one measurement during run-in period)
- Patients with a diffusive Na load of at least 1 mmoL/(L TBW) or 0.06g NaCl/(L TBW) (mean value during the run-in period).
Who cannot join
- General:
- Any conditions which could interfere with the patient's ability to comply with the study
- Patient is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
- In case of female patients: pregnancy (pregnancy test will be conducted at start and end of study with female patients aged ≤55 years) or lactation period
- Participation in an interventional clinical study during the preceding 30 days
- Previous participation in the same study
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- Study-specific:
- Patients treated with individualized sodium management over the last 3 months
- Severe hypoalbuminemia (≤30 g/L; 1 measurement within last 4 weeks)
- Hypernatremia (pre-dialytic plasma sodium concentration ≥145mmol/L; 1 measurement within last 4 weeks)
- Uncontrolled diabetic patients with glycated hemoglobin (HbA1C) >8%; 1 measurement within last 4 weeks
- Impossible reliable measurement of the different compartments by bioimpedance due to lower limb amputation or wearing of a unipolar pacemaker or metallic prostheses
- Life expectancy less than 6 months
- ONLINEplus HF treatments/hemofiltration treatments
- Single-needle treatments
- Dry weight < 40kg
- Active or chronic infections (HIV, SARS-CoV-2, HBV, HCV)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Fresenius Medical Care- DS, s.r.o.
Mariánské Lázně, 35301
Martin Jirovec, Dr., Martin-jirovec@freseniusmedicalcare.com
About this study
The SODIAH study is designed with the aim to assess the impact of isonatremic dialysis on interdialytic weight gain, fluid status, intradialytic hemodynamic stability, and incidence of intradialytic morbid events in dialysis patients. The study will be comparing the Na management option on the 6008 HD dialysis machines with the same machine without the Na management option turned on. Relevant performance and clinical data will be collected as well as information on patients' quality of life and wellbeing.
- Conditions
- End Stage Renal Disease
- Being tested
- Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control
- Keywords
- 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.
Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-controlDevice
Patients will be treated for 12 weeks thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient.
| Study group | Role | What they receive |
|---|---|---|
| Na zero-diffusive treatment | Other | Patients will be treated for 12 weeks sodium zero-diffusive prescription thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient. Receives: Device: Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control |
| standard treatment without Na-control | Other | Patients will be treated for 12 weeks either with standard dialysate prescription thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient. Receives: Device: Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interdialytic weight gain
Evaluation of the impact of sodium zero-diffusive dialysis on interdialytic weight gain will be analyzed in kg and % of dry weight
Measured: 12 weeks after start of study
Intradialytic hemodynamic stability
Evaluation of the impact of sodium zero-diffusive dialysis on intradialytic hemodynamic stability will be analyzed based on frequency of intradialytic hypotensive episodes
Measured: 12 weeks after start of study
Intradialytic hemodynamic stability
Evaluation of the impact of sodium zero-diffusive dialysis on intradialytic hemodynamic stability will be analyzed based on frequency of intradialytic hypertensive episodes
Measured: 12 weeks after start of study
Intradialytic morbid events
Evaluation of the impact of sodium zero-diffusive dialysis on the frequency of intradialytic morbid events will be analyzed
Measured: 12 weeks after start of study
Fluid status
Evaluation of the impact of sodium zero-diffusive dialysis on fluid status will be analyzed with regard to overhydration (L)
Measured: 12 weeks after start of study
Fluid status
Evaluation of the impact of sodium zero-diffusive dialysis on fluid status will be analyzed with regard to dry weight (kg)
Measured: 12 weeks after start of study
Secondary outcomes (6)
PRO: Thirst feeling
Evaluation of thirst feeling will be assessed via the Dialysis Thirst Inventory
Measured: 12 weeks after start of study
PRO: Thirst feeling
Evaluation of thirst feeling will be assessed via the Xerostomia Inventory
Measured: 12 weeks after start of study
PRO: Fatigue
Evaluation of fatigue will be assessed via the CONVINCE Dialysis Fatigue Scale (CFDS-10)
Measured: 12 weeks after start of study
PRO: Hypotensive episodes
Evaluation of hypotensive episodes will be assessed via the CONVINCE intradialytic symptoms (IDS) Scale - hypotensive episodes items
Measured: 12 weeks after start of study
PRO: HRQOL
Evaluation of health related quality of life (HRQOL) will be assessed using the validated Kidney Disease Quality of Life (KDQOL) survey KDQOL-36
Measured: 12 weeks after start of study
PRO: Health status
Evaluation of health status will be assessed via the validated EQ-5D-5L survey by EuroQol group
Measured: 12 weeks after start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start16 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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.
- 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
- Parallel groups
- Model description
- Prospective, open, controlled, parallel, randomized, interventional, multi-center, explorative
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Jirovec, Dr., Principal investigator, Fresenius Medical Care - DS, s.r.o., Marianske Lazne; Czech RepublicBjörn Meijers, Prof. Dr., Principal investigator, Universitaire Ziekenhuizen Leuven, Leuven, BelgiumMaria Jesus Izquierdo Ortiz, Dr., Principal investigator, Burgos University Hospital, Burgos, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341452
- Sponsor's protocol ID
- HD-NaM-01-EU
- Acronym
- SODIAH
- Status last verified
- Dec 2025
- First submitted
- 30 Jul 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis
- ClinicalTrials.gov ID
- NCT06341452
- Acronym / sponsor ID
- SODIAH / HD-NaM-01-EU
- Conditions
- End Stage Renal Disease
- Keywords
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Apr 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 SODIAH study is designed with the aim to assess the impact of isonatremic dialysis on interdialytic weight gain, fluid status, intradialytic hemodynamic stability, and incidence of intradialytic morbid events in dialysis patients. The study will be comparing the Na management option on the 6008 HD dialysis machines with the same machine without the Na management option turned on. Relevant performance and clinical data will be collected as well as information on patients' quality of life and wellbeing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, open, controlled, parallel, randomized, interventional, multi-center, explorative
| Arm | Type | Receives |
|---|---|---|
| Na zero-diffusive treatment | Other | Device: Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-controlPatients will be treated for 12 weeks sodium zero-diffusive prescription thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient. |
| standard treatment without Na-control | Other | Device: Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-controlPatients will be treated for 12 weeks either with standard dialysate prescription thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Informed consent signed and dated by study patient and authorized physician
- Minimum age of 18 years
- The patient is legally competent and able to understand the nature, risks, meaning, and consequences of the clinical trial and can subsequently declare her/his consent for participation in the clinical trial
- Patients with a chronic kidney disease stage 5D (end stage renal disease with a glomerular filtration rate of 15 ml/min or less) on dialysis as extracorporeal renal replacement therapy.
- Patients on dialysis (HD/HDF), at least 4h treatment time thrice weekly ≥ 3 months using a standard dialysate with a prescribed sodium concentration of 136 mmol/L
Key exclusion criteria (17 listed)
- Any conditions which could interfere with the patient's ability to comply with the study
- Patient is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
- In case of female patients: pregnancy (pregnancy test will be conducted at start and end of study with female patients aged ≤55 years) or lactation period
- Participation in an interventional clinical study during the preceding 30 days
- Previous participation in the same study
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 |
|---|---|---|
| Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-controlPatients will be treated for 12 weeks thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient. | Device | Na zero-diffusive treatment, standard treatment without Na-control |
Primary outcome
Interdialytic weight gain
Time frame: 12 weeks after start of study
Evaluation of the impact of sodium zero-diffusive dialysis on interdialytic weight gain will be analyzed in kg and % of dry weight
Intradialytic hemodynamic stability
Time frame: 12 weeks after start of study
Evaluation of the impact of sodium zero-diffusive dialysis on intradialytic hemodynamic stability will be analyzed based on frequency of intradialytic hypotensive episodes
Intradialytic hemodynamic stability
Time frame: 12 weeks after start of study
Evaluation of the impact of sodium zero-diffusive dialysis on intradialytic hemodynamic stability will be analyzed based on frequency of intradialytic hypertensive episodes
Intradialytic morbid events
Time frame: 12 weeks after start of study
Evaluation of the impact of sodium zero-diffusive dialysis on the frequency of intradialytic morbid events will be analyzed
Fluid status
Time frame: 12 weeks after start of study
Evaluation of the impact of sodium zero-diffusive dialysis on fluid status will be analyzed with regard to overhydration (L)
Fluid status
Time frame: 12 weeks after start of study
Evaluation of the impact of sodium zero-diffusive dialysis on fluid status will be analyzed with regard to dry weight (kg)
6 secondary outcomes
PRO: Thirst feeling
Time frame: 12 weeks after start of study
PRO: Thirst feeling
Time frame: 12 weeks after start of study
PRO: Fatigue
Time frame: 12 weeks after start of study
PRO: Hypotensive episodes
Time frame: 12 weeks after start of study
PRO: HRQOL
Time frame: 12 weeks after start of study
PRO: Health status
Time frame: 12 weeks after start of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Martin Jirovec, Dr. principal investigator
Fresenius Medical Care - DS, s.r.o., Marianske Lazne; Czech Republic
Björn Meijers, Prof. Dr. principal investigator
Universitaire Ziekenhuizen Leuven, Leuven, Belgium
Maria Jesus Izquierdo Ortiz, Dr. principal investigator
Burgos University Hospital, Burgos, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of End Stage Renal Disease, run by Fresenius Medical Care Deutschland GmbH at 1 site in Czechia.
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 11 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 22 Dec 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 Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Braun, Dr. (+49 6172 608 93488, Jennifer.Braun@freseniusmedicalcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interdialytic weight gain (time frame: 12 weeks after start of study). The study lists 6 primary outcomes in all. 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 22 Dec 2025.