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New dialysis salt strategy aims to reduce fluid gain and dizziness

NCT ID NCT06341452

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a personalized sodium (salt) management feature on dialysis machines can help people with end-stage kidney disease. It compares the new approach to standard dialysis in 130 adults. The goal is to see if it reduces weight gain between sessions, improves fluid balance, and prevents drops in blood pressure during treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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: * 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). Exclusion Criteria: 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 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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fresenius Medical Care- DS, s.r.o.

    RECRUITING

    Mariánské Lázně, 35301, Czechia

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