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RecruitingNCT06603324ECHOpedUpdated Sep 4, 2026

Analysis of Paediatric Treatments With multiFiltratePRO

An interventional study of CVVHD treatment in paediatric mode with multiFiltratePRO in Renal Failure and CVVHD, sponsored by Fresenius Medical Care Deutschland GmbH. Recruiting at 2 sites in 2 countries. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Fresenius Medical Care Deutschland GmbH (part of Fresenius Medical Care) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Not applicable
Ages
Up to 18 Years
Sex
All
01

Study summary

This clinical study evaluates the performance of the MultifiltratePro in pediatric mode for Continuous Venovenous Hemodiafiltration (CVVHD) in children. Its primary aim is to assess the efficacy of the MultifiltratePro in paediatric mode, specifically in achieving at least 80% of the prescribed effluent dose within 72 hours. Additionally, the study focuses on the safety of this mode in a paediatric setting, closely monitoring for clinical adverse events, hemodynamic instability, and electrolyte imbalances. Paediatric patients with body weights between 8kg and 40kg will be treated with the MultifiltratePro for a period of up to 10 days, with the treatment duration and approach being tailored to the severity of each patient's condition.

02

Conditions studied

  • Renal Failure
  • CVVHD

Keywords

  • Acute Kidney Injury
  • Renal Replacement Therapy
  • Haemodiafiltration
  • Contintious kidney replacement therapy
  • Paediatric
03

In context

Renal Insufficiency

1,409 studies on the registry are indexed under Renal Insufficiency; 143 are open to participants now.

This study's planned enrollment of 43 is close to the median of 40 across 1,058 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Fresenius Medical Care Deutschland GmbH is the lead sponsor of 36 studies on the registry; 7 are open to participants now.

Browse Fresenius Medical Care Deutschland GmbH studies →All Fresenius Medical Care studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

General:

  • Paediatric Patients:
  • 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 greater than 3 days
  • Children under 18 years
  • Body weight ≥8kg and \<40kg
  • Patients with clinical indication for CVVHD

Exclusion criteria

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 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:

  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (estimated)

Study arms

  • Experimental
    CVVHD treatment in paediatric mode with multiFiltratePRO

    Treatment of acute kidney injury paediatric patients with continuous veno-venous haemodiafiltration (CVVHD) in paediatric mode with multiFiltratePRO

    Device: CVVHD treatment in paediatric mode with multiFiltratePRO

Interventions

  • DeviceCVVHD treatment in paediatric mode with multiFiltratePRO

    Treatment of acute kidney injury paediatric patients with continuous veno-venous haemodiafiltration (CVVHD) in paediatric mode with multiFiltratePRO

06

What researchers measure

Primary outcomes

  1. Effluent dose

    Performance parameters of the paediatric treatment mode of multiFiltratePRO based on the effluent dose (prescribed vs achieved effluent dose) at 72 hours (at least 80% of the machine prescribed dose) are analysed

    Time frame: 0 hours and 72 hours after start of treatment

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Dec 2027, 26 months after the start.

Of 31 industry-sponsored interventional studies with no phase under Renal Insufficiency, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's planned 26 months is above that.

Counting every sponsor, half of 149 studies reached it within 22 months; a quarter within 8 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 22, 2024
First posted
Sep 19, 2024
StartActual
Oct 20, 2025
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06603324
Lead sponsor
Fresenius Medical Care Deutschland GmbH
Collaborators
Alcedis GmbH
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Oct 20, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 4, 2026

Study contacts

Jana Schmitt
Contact
Jana.Schmitt@freseniusmedicalcare.com
+49 6172 268 6305
Lena Wachter
Contact
lena.wachter@freseniusmedicalcare.com
+49 6172 2686464
Michael Merker, Dr. med.
principal investigator · Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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