End-stage Renal DiseaseMIMOSANCT06327750
The Microcirculation, Dialysis Modality and Sequestered Salt
A study testing Hemodialysis (DNa = PNa), Hemodialysis (DNa<PNa) and Hemodialysis after isolated ultrafiltration (DNa=PNa) in people with End-stage Renal Disease, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
Trial summary
The aim of this clinical trial is to investigate the effect of 5 different dialysis treatments (combinations of dialysis mode and dialysis fluid sodium content) on the microcirculation (MC) and sequestered sodium content (SSC) in adult prevalent end-stage kidney disease (ESKD) patients treated with hemodialysis (HD)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Hemodialysis (DNa = PNa), Hemodialysis (DNa<PNa) and Hemodialysis after isolated ultrafiltration (DNa=PNa)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesNetherlands
- Study dates
- 2 Jun 2026to May 2028
- 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
- Age ≥18 years
- Treatment with HD or HDF 3 x per week during at least 4 hours for at least 3 months
- Blood flow rate feasiblity of ≥350 ml/min
- Residual diuresis <200 ml/day
- Plasma Na before dialysis 137-145 mmol/L at baseline
- spKt/Vurea ≥ 1.2
- Ability to understand study procedures and willingness to provide informed consent
Who cannot join
- Severe incompliance to dialysis procedure and accompanying prescriptions, especially frequency and duration of dialysis treatment
- Life expectancy < 3 months due to non-renal disease
- Expected transplantation within 6 months
- Access recirculation > 10%
- Participation in another clinical intervention trial
- Metal implants (e.g. implantable cardioverter defibrillators)
- Severe obesity (MRI Ø 60 cm ≈ abdominal circumference ≤ 188 cm)
- Claustrophobia
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Niercentrum aan de Amstel (Elyseklinieken)
Amstelveen, North Holland, 1186AM
Fenna G.F. van Breda, MD PhD, +31205669111, g.vanbreda@amsterdamumc.nl
- Recruiting
Dianet Amsterdam
Amsterdam, North Holland, 1105 AZ
Muriel P.C. Grooteman, MD PhD, +312-7320908, mpc.grooteman@amsterdamumc.nl
Lily Jakulj, MD PhD, +31650100023, l.jakulj@amsterdamumc.nl
About this study
The aim of this clinical trial is to investigate the effect of 5 different dialysis treatments (combinations of dialysis mode and dialysis fluid sodium content) on the microcirculation (MC) and sequestered sodium content (SSC) in adult prevalent end-stage kidney disease (ESKD) patients treated with hemodialysis (HD) or hemodiafiltration (HDF). The main questions it aims to answer are:
- What are the effects on the sequestered sodium content and microcirculation after 4 weeks of treatment with the following dialysis modes?
Read more
- HDF with an expected zero diffusive sodium balance (Dialysate sodium concentration (DNa)= Plasma sodium concentration (PNa)) compared to
- HDF with an expected diffusive sodium efflux (DNa < PNa, difference 3 mmol/L) compared to
- HD with an expected zero diffusive sodium balance (DNa = PNa) compared to
- HD with an expected diffusive sodium efflux (DNa < PNa, difference 3 mmol/L) compared to
- Isolated ultrafiltration for 30 minutes followed by HD with an expected zero diffusive sodium balance (DNa = PNa)
- Are the SSC and MC interrelated in this patient group?
This study is a randomized cross-over trial. Participants will be subjected to the abovementioned dialysis treatment modes in random order.
Read the detailed description
The life expectancy of patients with end-stage kidney disease (ESKD) is poor. Post-dilution online hemodiafiltration (HDF) is associated with a lower mortality than standard hemodialysis (HD), especially when a high convection volume is achieved (high-volume HDF; hvHDF). It is unclear, however, why (hv)HDF improves survival. Neither an increased clearance of middle molecular weight uremic toxins, nor an improved bio-incompatibility can explain the difference. As the effects are already observed within 2.5 years, recovery of a functional disorder is more likely than restoration of structural alterations. The recuperation of vascular dysfunction may be the missing piece of the puzzle. Previous literature showed (1) that the microcirculation (MC) is severely disturbed in dialysis patients, (2) excess sodium can bind to glycosaminoglycans in the interstitium and in the glycocalyx of blood vessels without commensurate water retention (sequestered sodium content [SSC]) and (3) that in patients with non-dialysis dependent chronic kidney disease, a disturbed SSC is related to capillary rarefaction and dysfunction. Therefore, the present study aims to assess the influences of both the modality (HD and HDF) and the dialysate sodium concentration (DNa) on the SSC and the MC.
Therefore the following hypotheses will be evaluated: (1, 2) treatment with hvHDF improves the SSC and MC, if compared to HD; (3, 4) disorders of the SSC and the MC are influenced by differences between the dialysate sodium [DNa] and plasma sodium [PNa] concentrations; (5) SSC and MC are interrelated in this patient group.
- Conditions
- End-stage Renal Disease
- Being tested
- Hemodialysis (DNa = PNa), Hemodialysis (DNa<PNa), Hemodialysis after isolated ultrafiltration (DNa=PNa), High volume hemodiafiltration (DNa=PNa), High volume hemodiafiltration (DNa<PNa)
- Keywords
- Hemodialysis, Hemodiafiltration, Microcirculation, Sequestered salt content, isolated ultrafiltration, dialysate sodium
- 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 (DNa = PNa)Device
High-flux hemodialysis with an expected zero diffusive sodium balance (DNa = PNa)
Hemodialysis (DNa<PNa)Device
High-flux hemodialysis with expected diffusive sodium efflux (DNa<PNa, difference: 3 mmol/L)
Hemodialysis after isolated ultrafiltration (DNa=PNa)Device
High-flux hemodialysis after isolated ultrafiltration with an expected zero diffusive sodium balance (DNa=PNa)
High volume hemodiafiltration (DNa=PNa)Device
High volume hemodiafiltration with an expected zero diffusive sodium balance (DNa=PNa) Convection volume: ≥23L/session
High volume hemodiafiltration (DNa<PNa)Device
High volume hemodiafiltration with expected diffusive sodium efflux (DNa<PNa, difference: 3 mmol/L) Convection volume: ≥23L/session
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis (DNa=PNa) | Active comparator | High-flux hemodialysis with expected diffusive zero sodium balance (DNa=PNa) Receives: Device: Hemodialysis (DNa<PNa); Device: Hemodialysis after isolated ultrafiltration (DNa=PNa); Device: High volume hemodiafiltration (DNa=PNa); Device: High volume hemodiafiltration (DNa<PNa) |
| Hemodialysis (DNa<PNa) | Active comparator | High-flux hemodialysis with expected diffusive sodium efflux (DNa<PNa, difference: 3 mmol/L) Receives: Device: Hemodialysis (DNa = PNa); Device: Hemodialysis after isolated ultrafiltration (DNa=PNa); Device: High volume hemodiafiltration (DNa=PNa); Device: High volume hemodiafiltration (DNa<PNa) |
| Hemodialysis after isolated ultrafiltration (DNa=PNa) | Active comparator | High-flux hemodialysis after isolated ultrafiltration with expected zero sodium balance (DNa=PNa) Receives: Device: Hemodialysis (DNa = PNa); Device: Hemodialysis (DNa<PNa); Device: High volume hemodiafiltration (DNa=PNa); Device: High volume hemodiafiltration (DNa<PNa) |
| High volume hemodiafiltration (DNa=PNa) | Active comparator | High volume hemodiafiltration with expected diffusive zero sodium balance (DNa=PNa) Receives: Device: Hemodialysis (DNa = PNa); Device: Hemodialysis (DNa<PNa); Device: Hemodialysis after isolated ultrafiltration (DNa=PNa); Device: High volume hemodiafiltration (DNa<PNa) |
| High volume hemodiafiltration (DNa<PNa) | Active comparator | High volume hemodiafiltration with expected diffusive sodium efflux (DNa<PNa, difference: 3 mmol/L) Receives: Device: Hemodialysis (DNa = PNa); Device: Hemodialysis (DNa<PNa); Device: Hemodialysis after isolated ultrafiltration (DNa=PNa); Device: High volume hemodiafiltration (DNa=PNa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sequestered salt content (SSC) in muscle
SSC in muscle tissue measured with a 7 Tesla 23-Sodium MRI
Measured: up to 20 weeks; assessed every 4 weeks before the last dialysis session of each treatment period (i.e. 5 times in total)
Secondary outcomes (19)
Sequestered salt content (SSC) in the skin
SSC in the skin measured with a 7 Tesla 23-Sodium MRI
Measured: up to 20 weeks; assessed every 4 weeks before the last dialysis session of each treatment period (i.e. 5 times in total)
Skin microcirculation
Skin microcirculatory perfusion/vasoreactivity (arbitrary units) measured with a laser speckle contrast analysis (LASCA) perfusion imager
Measured: up to 20 weeks; assessed every 4 weeks before the last dialysis session of each treatment period (i.e. 5 times in total)
Intradialytic hypotension
A systolic blood pressure (SBP) ≤ 90 mmHg in patients with a pre-dialysis SBP < 160 mmHg and a SBP < 100 mmHg in patients with a pre-dialysis SBP ≥ 160 mmHg.
Measured: up to 4 hours (=one dialysis treatment); assessed during all dialysis sessions (12 treatments per intervention, measured 4x/hour)
Change in intradialytic blood pressure
Change in systolic and diastolic blood pressure (mmHg) during one dialysis session
Measured: up to 4 hours (=one dialysis treatment); assessed during all dialysis sessions (12 treatments per intervention, measured 4x/hour)
Peridialytic blood pressure
Change in systolic and diastolic blood pressure (mmHg) between dialysis sessions
Measured: up to 24 hours (=one interdialytic day): measured 3x/day every 4 weeks during the last interdialytic day of each treatment period (i.e. 5 times in total)
Change in CK-MB
Marker of cardiac damage, assessment in blood from arterial line of extracorporeal circuit
Measured: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in high sensitivity C-reactive protein (hs-CRP)
Marker of inflammation, assessment in blood from arterial line of extracorporeal circuit
Measured: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in interleukin-6 receptor (IL-6R)
Marker of inflammation, assessment in blood from arterial line of extracorporeal circuit
Measured: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in soluble CD163 (sCD163)
Marker of inflammation, assessment in blood from arterial line of extracorporeal circuit
Measured: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in soluble intercellular adhesion molecule-1 (s-ICAM-1)
Marker of inflammation, assessment in blood from arterial line of extracorporeal circuit
Measured: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in serum glycosaminoglycans
Marker related to sequestered sodium content, assessment in blood from arterial line of extracorporeal circuit
Measured: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in syndecan-1
Marker related to sequestered sodium content, assessment in blood from arterial line of extracorporeal circuit
Measured: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in vascular endothelial growth factor C (VEGF-C)
Marker related to sequestered sodium content, assessment in blood from arterial line of extracorporeal circuit
Measured: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in extracellular vesicles (EVs)
Marker for tissue-injury and inflammation, assessment in blood from arterial line of extracorporeal circuit
Measured: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in skin microcirculation
Change in skin microcirculatory perfusion/vasoreactivity (arbitrary units) measured with a laser speckle contrast analysis (LASCA) perfusion imager during one dialysis session. This will be assessed in 5 patients only.
Measured: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in sequestered salt content (SSC)
Change in SSC measured with a 7 Tesla 23-Sodium MRI during one dialysis session. This will be assessed in 5 patients only.
Measured: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
modified Dialysis symptom index (mDSI)
Standardized questionnaire for the evaluation of physical symptoms and recovery time in dialysis patients, consisting of 13 items. Participants rate the severity of each item on a 5-point likert scale, ranging from 0 ('not at all') to 4 ('very much'). Higher scores indicate a greater perceived severity of symptoms.
Measured: up to 20 weeks; evaluated every 4 weeks, during/after the last dialysis session of each treatment period
Thirst distress scale (TDS)
The thirst distress scale is a 6-item questionnaire that measures thirst distress on a scale from 1 to 5, where 1 corresponds to 'Strongly disagree' and 5 to 'Strongly agree'. Higher scores indicate greater perceived thirst distress.
Measured: up to 20 weeks; evaluated every 4 weeks, during/after the last dialysis session of each treatment period
EQ Visual analogue scale (EQ VAS)
The EQ VAS records the patients's self-rated health-related quality of life on a vertical visual analogue scale where 0 means 'the worst health you can imagine' and 100 means 'the best health you can imagine'. Higher scores indicate a better perceived health-related quality of life.
Measured: up to 20 weeks; evaluated every 4 weeks, during/after the last dialysis session of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start2 Jun 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (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
- Crossover
- Model description
- Randomized cross-over trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Kidney Foundation, Niercentrum aan de Amstel, B Braun Medical supplies trial fluids
- Responsible party
- Principal investigator, Muriel P.C. Grooteman, Amsterdam UMC, location VUmc
- Investigators
- Muriel PC Grooteman, MD PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327750
- Sponsor's protocol ID
- NL-007008
- Other IDs
- METC NedMec+
- Acronym
- MIMOSA
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and/or analysed during the current study are not publicly available due to patient privacy and confidentiality restrictions, but are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Microcirculation, Dialysis Modality and Sequestered Salt
- ClinicalTrials.gov ID
- NCT06327750
- Acronym / sponsor ID
- MIMOSA / NL-007008
- Conditions
- End-stage Renal Disease
- Keywords
- Hemodialysis, Hemodiafiltration, Microcirculation, Sequestered salt content, isolated ultrafiltration, dialysate sodium
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Dutch Kidney Foundation, Niercentrum aan de Amstel, B Braun Medical supplies trial fluids
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 25 Mar 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 aim of this clinical trial is to investigate the effect of 5 different dialysis treatments (combinations of dialysis mode and dialysis fluid sodium content) on the microcirculation (MC) and sequestered sodium content (SSC) in adult prevalent end-stage kidney disease (ESKD) patients treated with hemodialysis (HD) or hemodiafiltration (HDF). The main questions it aims to answer are:
- What are the effects on the sequestered sodium content and microcirculation after 4 weeks of treatment with the following dialysis modes?
- HDF with an expected zero diffusive sodium balance (Dialysate sodium concentration (DNa)= Plasma sodium concentration (PNa)) compared to
- HDF with an expected diffusive sodium efflux (DNa < PNa, difference 3 mmol/L) compared to
- HD with an expected zero diffusive sodium balance (DNa = PNa) compared to
- HD with an expected diffusive sodium efflux (DNa < PNa, difference 3 mmol/L) compared to
- Isolated ultrafiltration for 30 minutes followed by HD with an expected zero diffusive sodium balance (DNa = PNa)
- Are the SSC and MC interrelated in this patient group?
This study is a randomized cross-over trial. Participants will be subjected to the abovementioned dialysis treatment modes in random order.
Detailed description
The life expectancy of patients with end-stage kidney disease (ESKD) is poor. Post-dilution online hemodiafiltration (HDF) is associated with a lower mortality than standard hemodialysis (HD), especially when a high convection volume is achieved (high-volume HDF; hvHDF). It is unclear, however, why (hv)HDF improves survival. Neither an increased clearance of middle molecular weight uremic toxins, nor an improved bio-incompatibility can explain the difference. As the effects are already observed within 2.5 years, recovery of a functional disorder is more likely than restoration of structural alterations. The recuperation of vascular dysfunction may be the missing piece of the puzzle. Previous literature showed (1) that the microcirculation (MC) is severely disturbed in dialysis patients, (2) excess sodium can bind to glycosaminoglycans in the interstitium and in the glycocalyx of blood vessels without commensurate water retention (sequestered sodium content [SSC]) and (3) that in patients with non-dialysis dependent chronic kidney disease, a disturbed SSC is related to capillary rarefaction and dysfunction. Therefore, the present study aims to assess the influences of both the modality (HD and HDF) and the dialysate sodium concentration (DNa) on the SSC and the MC.
Therefore the following hypotheses will be evaluated: (1, 2) treatment with hvHDF improves the SSC and MC, if compared to HD; (3, 4) disorders of the SSC and the MC are influenced by differences between the dialysate sodium [DNa] and plasma sodium [PNa] concentrations; (5) SSC and MC are interrelated in this patient group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- Randomized cross-over trial
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis (DNa=PNa) | Active comparator | Device: Hemodialysis (DNa<PNa), Device: Hemodialysis after isolated ultrafiltration (DNa=PNa), Device: High volume hemodiafiltration (DNa=PNa), Device: High volume hemodiafiltration (DNa<PNa)High-flux hemodialysis with expected diffusive zero sodium balance (DNa=PNa) |
| Hemodialysis (DNa<PNa) | Active comparator | Device: Hemodialysis (DNa = PNa), Device: Hemodialysis after isolated ultrafiltration (DNa=PNa), Device: High volume hemodiafiltration (DNa=PNa), Device: High volume hemodiafiltration (DNa<PNa)High-flux hemodialysis with expected diffusive sodium efflux (DNa<PNa, difference: 3 mmol/L) |
| Hemodialysis after isolated ultrafiltration (DNa=PNa) | Active comparator | Device: Hemodialysis (DNa = PNa), Device: Hemodialysis (DNa<PNa), Device: High volume hemodiafiltration (DNa=PNa), Device: High volume hemodiafiltration (DNa<PNa)High-flux hemodialysis after isolated ultrafiltration with expected zero sodium balance (DNa=PNa) |
| High volume hemodiafiltration (DNa=PNa) | Active comparator | Device: Hemodialysis (DNa = PNa), Device: Hemodialysis (DNa<PNa), Device: Hemodialysis after isolated ultrafiltration (DNa=PNa), Device: High volume hemodiafiltration (DNa<PNa)High volume hemodiafiltration with expected diffusive zero sodium balance (DNa=PNa) |
| High volume hemodiafiltration (DNa<PNa) | Active comparator | Device: Hemodialysis (DNa = PNa), Device: Hemodialysis (DNa<PNa), Device: Hemodialysis after isolated ultrafiltration (DNa=PNa), Device: High volume hemodiafiltration (DNa=PNa)High volume hemodiafiltration with expected diffusive sodium efflux (DNa<PNa, difference: 3 mmol/L) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- Treatment with HD or HDF 3 x per week during at least 4 hours for at least 3 months
- Blood flow rate feasiblity of ≥350 ml/min
- Residual diuresis <200 ml/day
- Plasma Na before dialysis 137-145 mmol/L at baseline
Key exclusion criteria (8 listed)
- Severe incompliance to dialysis procedure and accompanying prescriptions, especially frequency and duration of dialysis treatment
- Life expectancy < 3 months due to non-renal disease
- Expected transplantation within 6 months
- Access recirculation > 10%
- Participation in another clinical intervention trial
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 (DNa = PNa)High-flux hemodialysis with an expected zero diffusive sodium balance (DNa = PNa) | Device | Hemodialysis (DNa<PNa), Hemodialysis after isolated ultrafiltration (DNa=PNa), High volume hemodiafiltration (DNa<PNa), High volume hemodiafiltration (DNa=PNa) |
| Hemodialysis (DNa<PNa)High-flux hemodialysis with expected diffusive sodium efflux (DNa<PNa, difference: 3 mmol/L) | Device | Hemodialysis (DNa=PNa), Hemodialysis after isolated ultrafiltration (DNa=PNa), High volume hemodiafiltration (DNa<PNa), High volume hemodiafiltration (DNa=PNa) |
| Hemodialysis after isolated ultrafiltration (DNa=PNa)High-flux hemodialysis after isolated ultrafiltration with an expected zero diffusive sodium balance (DNa=PNa) | Device | Hemodialysis (DNa<PNa), Hemodialysis (DNa=PNa), High volume hemodiafiltration (DNa<PNa), High volume hemodiafiltration (DNa=PNa) |
| High volume hemodiafiltration (DNa=PNa)High volume hemodiafiltration with an expected zero diffusive sodium balance (DNa=PNa) Convection volume: ≥23L/session | Device | Hemodialysis (DNa<PNa), Hemodialysis (DNa=PNa), Hemodialysis after isolated ultrafiltration (DNa=PNa), High volume hemodiafiltration (DNa<PNa) |
| High volume hemodiafiltration (DNa<PNa)High volume hemodiafiltration with expected diffusive sodium efflux (DNa<PNa, difference: 3 mmol/L) Convection volume: ≥23L/session | Device | Hemodialysis (DNa<PNa), Hemodialysis (DNa=PNa), Hemodialysis after isolated ultrafiltration (DNa=PNa), High volume hemodiafiltration (DNa=PNa) |
Primary outcome
Sequestered salt content (SSC) in muscle
Time frame: up to 20 weeks; assessed every 4 weeks before the last dialysis session of each treatment period (i.e. 5 times in total)
SSC in muscle tissue measured with a 7 Tesla 23-Sodium MRI
19 secondary outcomes
Sequestered salt content (SSC) in the skin
Time frame: up to 20 weeks; assessed every 4 weeks before the last dialysis session of each treatment period (i.e. 5 times in total)
Skin microcirculation
Time frame: up to 20 weeks; assessed every 4 weeks before the last dialysis session of each treatment period (i.e. 5 times in total)
Intradialytic hypotension
Time frame: up to 4 hours (=one dialysis treatment); assessed during all dialysis sessions (12 treatments per intervention, measured 4x/hour)
Change in intradialytic blood pressure
Time frame: up to 4 hours (=one dialysis treatment); assessed during all dialysis sessions (12 treatments per intervention, measured 4x/hour)
Peridialytic blood pressure
Time frame: up to 24 hours (=one interdialytic day): measured 3x/day every 4 weeks during the last interdialytic day of each treatment period (i.e. 5 times in total)
Change in CK-MB
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in high sensitivity C-reactive protein (hs-CRP)
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in interleukin-6 receptor (IL-6R)
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in soluble CD163 (sCD163)
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in soluble intercellular adhesion molecule-1 (s-ICAM-1)
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in serum glycosaminoglycans
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in syndecan-1
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in vascular endothelial growth factor C (VEGF-C)
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in extracellular vesicles (EVs)
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in skin microcirculation
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in sequestered salt content (SSC)
Time frame: up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
modified Dialysis symptom index (mDSI)
Time frame: up to 20 weeks; evaluated every 4 weeks, during/after the last dialysis session of each treatment period
Thirst distress scale (TDS)
Time frame: up to 20 weeks; evaluated every 4 weeks, during/after the last dialysis session of each treatment period
EQ Visual analogue scale (EQ VAS)
Time frame: up to 20 weeks; evaluated every 4 weeks, during/after the last dialysis session of each treatment period
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 11 Sep 2026.
- Individual participant dataSharing planned: No. The datasets generated and/or analysed during the current study are not publicly available due to patient privacy and confidentiality restrictions, but are available from the corresponding author on reasonable request.
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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.
Muriel PC Grooteman, MD PhD principal investigator
Amsterdam UMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodialysis (DNa = PNa), Hemodialysis (DNa<PNa) and Hemodialysis after isolated ultrafiltration (DNa=PNa) in people with End-stage Renal Disease, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
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 7 inclusion and 8 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 Muriel PC Grooteman, MD PhD (+3120 566 5990, mpc.grooteman@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sequestered salt content (SSC) in muscle (time frame: up to 20 weeks; assessed every 4 weeks before the last dialysis session of each treatment period (i.e. 5 times in total)). 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 11 Sep 2026.