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New dialysis tech aims to improve waste removal for kidney patients

NCT ID NCT06390592

Disease control Sponsor: Fresenius Medical Care Deutschland GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 2 times

Summary

This trial tests a new feature called FlexPoint on a peritoneal dialysis machine used at home. The feature adjusts fluid volume and dwell time during treatment. Researchers will compare three different settings in 24 adults with chronic kidney disease to see which works best for removing waste and excess fluid. The goal is to make nightly dialysis more effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PD cycler with FlexPoint technology (device)
What this could lead to
If successful, this could improve how well peritoneal dialysis removes waste and excess fluid, potentially leading to better daily management of kidney failure.
What could go wrong
This is a small, early-stage trial with only 24 participants, so results may not apply to everyone. The technology is a device adjustment, not a new drug or cure, so benefits are likely modest.

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 24 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

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: * Informed consent signed and dated by study patient and investigator/ authorised physician * Minimum age of 18 years * CKD patients with indication for renal replacement therapy * Patients being treated with APD for at least 3 months * Patients using the sleep•safe harmony PD cycler (version 3.1) * Fluid status regularly monitored with Body Composition Monitor (BCM) * Proper functioning catheter * Intraperitoneal Pressure (IPP) ≤ 18 cm H2O * Ability to understand the nature and requirements of the study Exclusion Criteria: * Any conditions which could interference with the patient's ability to comply with the study * Previous participation in the same study * Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg) * Patients receiving polyglucose containing PD solution * Respiratory or abdominal wall disease deemed to contraindicate intraperitoneal fill volume (FV) manipulation * Patients who suffer from peritonitis/exit site infection during the last 4 weeks * Women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period * Life expectancy \<3 months * Participation in an interventional clinical study during the preceding 90 days

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome kidney failure

As listed by the trial registrant

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

Chronic kidney disease Renal failure

How to take part

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

  1. 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 ↗

  2. A doctor treating you

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