Renal FailureECHOpedNCT06603324
Analysis of Paediatric Treatments With multiFiltratePRO
A study testing CVVHD treatment in paediatric mode with multiFiltratePRO in people with Renal Failure and CVVHD, run by Fresenius Medical Care Deutschland GmbH at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Renal Failure, CVVHD
- What is being tested?
- CVVHD treatment in paediatric mode with multiFiltratePRO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Oct 2025to Dec 2027
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
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- Estimated life expectancy greater than 3 days
- Children under 18 years
- Body weight ≥8kg and <40kg
- Patients with clinical indication for CVVHD
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Czechia1 site, 1 recruiting
- Recruiting
Fakultní nemocnice Ostrava
Ostrava-Poruba, 708 52
Tomáš Zaoral, Dr. med., tomas.zaoral@fno.cz
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Frankfurt
Frankfurt, 60590
Michael Merker, Dr. med., michael.merker@med.uni-frankfurt.de
About this study
Official title: Efficacy and Safety of Paediatric CVVHD Treatment With MultiFiltratePRO: A Prospective Multicenter Study
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.
- Conditions
- Renal Failure, CVVHD
- Being tested
- CVVHD treatment in paediatric mode with multiFiltratePRO
- Keywords
- Acute Kidney Injury, Renal Replacement Therapy, Haemodiafiltration, Contintious kidney replacement therapy, Paediatric
- Medical subject headings
- Renal Insufficiency, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVVHD treatment in paediatric mode with multiFiltratePRODevice
Treatment of acute kidney injury paediatric patients with continuous veno-venous haemodiafiltration (CVVHD) in paediatric mode with multiFiltratePRO
| Study group | Role | What they receive |
|---|---|---|
| CVVHD treatment in paediatric mode with multiFiltratePRO | Experimental | Treatment of acute kidney injury paediatric patients with continuous veno-venous haemodiafiltration (CVVHD) in paediatric mode with multiFiltratePRO Receives: Device: CVVHD treatment in paediatric mode with multiFiltratePRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 hours and 72 hours after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Oct 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Treatment of acute kidney injury paediatric patients with continuous veno-venous haemodiafiltration (CVVHD) in paediatric mode with multiFiltratePRO
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alcedis GmbH
- Responsible party
- Sponsor
- Investigators
- Michael Merker, Dr. med., Principal investigator, Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603324
- Sponsor's protocol ID
- CVVHD-PED-01-EU
- Acronym
- ECHOped
- Status last verified
- Sep 2026
- First submitted
- 22 Feb 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Paediatric CVVHD Treatment With MultiFiltratePRO: A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT06603324
- Acronym / sponsor ID
- ECHOped / CVVHD-PED-01-EU
- Conditions
- Renal Failure, CVVHD
- Keywords
- Acute Kidney Injury, Renal Replacement Therapy, Haemodiafiltration, Contintious kidney replacement therapy, Paediatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Alcedis GmbH
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Sep 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment of acute kidney injury paediatric patients with continuous veno-venous haemodiafiltration (CVVHD) in paediatric mode with multiFiltratePRO
| Arm | Type | Receives |
|---|---|---|
| CVVHD treatment in paediatric mode with multiFiltratePRO | Experimental | Device: CVVHD treatment in paediatric mode with multiFiltratePROTreatment of acute kidney injury paediatric patients with continuous veno-venous haemodiafiltration (CVVHD) in paediatric mode with multiFiltratePRO |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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.
- Estimated life expectancy greater than 3 days
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| CVVHD treatment in paediatric mode with multiFiltratePROTreatment 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 |
Primary outcome
Effluent dose
Time frame: 0 hours and 72 hours after start of treatment
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
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 4 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Michael Merker, Dr. med. principal investigator
Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CVVHD treatment in paediatric mode with multiFiltratePRO in people with Renal Failure and CVVHD, run by Fresenius Medical Care Deutschland GmbH at 2 sites in 2 countries.
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 10 inclusion and 11 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 4 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 Czechia, Germany. 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 Jana Schmitt (+49 6172 268 6305, Jana.Schmitt@freseniusmedicalcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effluent dose (time frame: 0 hours and 72 hours after start of treatment). 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 4 Sep 2026.