New dialysis device for kids: a safer way to clean blood?

NCT ID NCT06603324

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

First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study tests a special dialysis machine, the MultiFiltratePRO, in children with acute kidney failure. The goal is to see if it can deliver at least 80% of the prescribed treatment within 72 hours while being safe. About 43 children weighing between 8 and 40 kilograms will be treated for up to 10 days, and doctors will watch for side effects like low blood pressure or electrolyte problems.

What this could mean

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

Active substance: MultiFiltratePRO device for continuous venovenous hemodiafiltration (CVVHD)
What this could lead to: If successful, this could confirm that the MultiFiltratePRO device safely and effectively delivers dialysis to children, improving care for pediatric kidney failure.
What could go wrong: This is a small, early-stage study with only 43 participants, so results may not apply to all children. Risks include side effects like low blood pressure or electrolyte imbalances.

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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 43 people

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

Started

Oct 2025

Expected to finish

Dec 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

Up to 18 years

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: * Paediatric Patients: * Informed consent signed and dated by legal representative and investigator/ authorized physician. * The minors have received the information referred to in Article 63(2) MDR in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children. * The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) MDR to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator. Study-specific: * Estimated life expectancy greater than 3 days * Children under 18 years * Body weight ≥8kg and \<40kg * Patients with clinical indication for CVVHD Exclusion criteria: General: * Any conditions which could interfere with the patient's ability to comply with the study * Patient or legal representative is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations * In case of female patients: pregnancy or lactation period * Participation in an interventional clinical study during the preceding 30 days * Previous participation in the same study Study-specific: * Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT Type II) * Uncontrolled bleeding and coagulation disorders * Decision to limit therapeutic interventions * Inability to establish the required vascular access

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Conditions

The condition(s) this trial relates to.

acute kidney injury kidney failure

As listed by the trial registrant

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

CVVHD Renal failure

How to take part

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

The places running it

2 sites in 2 countries. The list below names each one and where it is.
The official record

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

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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.

New dialysis device for kids: a safer way to clean blood?

What the study statuses mean