Acute Kidney InjuryCKRT-AKINCT06236984
Retrospective Data Analysis of CKRT (Continuous Kidney Replacement Therapy) Treatments in Adult Mode With multiFiltratePRO
An observational study of Acute Kidney Injury and Renal Failure, run by Fresenius Medical Care Deutschland GmbH at 3 sites in Germany.
Trial summary
The multiFiltratePRO is a device for extracorporeal blood purification treatments. In this retrospective analysis, the treatments of patients who received at least one treatment with the investigational device as mentioned between January 2015 and January 2024 will be documented in a chronological order. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Renal Failure
- What is being tested?
- multiFiltratePRO with all CKRT treatment modes
- How many people
- 80 participants
- Where
- 3 sitesGermany
- Study dates
- 1 May 2024to 21 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with an indication for the extracorporeal blood treatment suffering from AKI who received CKRT adult mode treatment
Who may be able to join
- All patients with an indication for the extracorporeal blood treatment suffering from AKI who received CKRT adult mode treatment for at least once with: Heparin-Continuous veno-venous hemofiltration Hep-CVVH (Pre CVVH, Post CVVH and Pre-Post CVVH), Heparin-Continuous veno-venous hemodialysis Hep-CVVHD, Heparin-Continuous veno-venous hemodiafiltration Hep-CVVHDF (Pre-CVVHDF and Post-CVVHDF), Citrate-Calcium(Ci-Ca)-CVVHD, Citrate-Calcium(Ci-Ca) CVVHDF, between January 2015 and January 2024, with the investigational device, have to be included in the study in chronological order.
- No age restriction for heparin modes
- Age ≥ 18 years for Ci-Ca modes at treatment start
- Patient´s body weight ≥ 40kg irrespective of age
- Acute Kidney Injury (AKI) OR chronic dialysis patients with clinical indication for CKRT
Who cannot join
- Participation in an interventional clinical study during the retrospectively collected CKRT treatment data
- Previous participation in the same study
- No study-specific exclusion criteria based on contraindications due to the retrospective character of the study
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Evangelisches Klinikum Bethel gGmbH Universitätsklinikum OWL der Universität Bielefeld
Bielefeld, North Rhine-Westphalia, 33617
Klinikum Leverkusen gGmbH
Leverkusen, North Rhine-Westphalia, 51375
Klinikum Ludwigshafen
Ludwigshafen am Rhein, Rhineland-Palatinate, 67063
About this study
Official title: Retrospective Data Analysis of CKRT Treatments in Adult Mode With multiFiltratePRO
The multiFiltratePRO is a device for extracorporeal blood purification treatments.
In this retrospective analysis, the treatments of patients who received at least one treatment with the investigational device as mentioned between January 2015 and January 2024 will be documented in a chronological order. No further control treatments will be investigated in this one-arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the multiFiltratePRO system.
- Conditions
- Acute Kidney Injury, Renal Failure
- Being tested
- multiFiltratePRO with all CKRT treatment modes
- Keywords
- Continuous kidney replacement therapy
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiFiltratePRO with all CKRT treatment modesOther
Retrospective Data Analysis of CKRT treatments in adult mode with multiFiltratePRO
| Study group | Role | What they receive |
|---|---|---|
| AKI patients | Patients with an indication for the extracorporeal blood treatment suffering from AKI who received CKRT adult mode treatment Receives: Other: multiFiltratePRO with all CKRT treatment modes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of treatments with multiFiltratePRO
Performance data of defined multiFiltratePRO CKRT treatments in adult mode with regard to fluid balance (effluent dose) are analysed
Measured: documentation of max.7 treatment days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 May 2024
- Primary completion21 Feb 2025
- Study completion21 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Metronomia Clinical Research GMBH
- Responsible party
- Sponsor
- Investigators
- Rainer Borgstedt, Dr. med., Principal investigator, Evangelisches Klinikum Bethel gGmbH Universitätsklinikum OWL der Universität Bielefeld
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236984
- Sponsor's protocol ID
- CKRT-AKI-01-EU
- Acronym
- CKRT-AKI
- Status last verified
- Jun 2025
- First submitted
- 5 Jan 2024
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Data Analysis of CKRT Treatments in Adult Mode With multiFiltratePRO
- ClinicalTrials.gov ID
- NCT06236984
- Acronym / sponsor ID
- CKRT-AKI / CKRT-AKI-01-EU
- Conditions
- Acute Kidney Injury, Renal Failure
- Keywords
- Continuous kidney replacement therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Metronomia Clinical Research GMBH
- Study start
- 1 May 2024 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- 21 Feb 2025 (actual)
- First posted
- 1 Feb 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.
The multiFiltratePRO is a device for extracorporeal blood purification treatments.
In this retrospective analysis, the treatments of patients who received at least one treatment with the investigational device as mentioned between January 2015 and January 2024 will be documented in a chronological order. No further control treatments will be investigated in this one-arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the multiFiltratePRO system.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AKI patients | – | Other: multiFiltratePRO with all CKRT treatment modesPatients with an indication for the extracorporeal blood treatment suffering from AKI who received CKRT adult mode treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with an indication for the extracorporeal blood treatment suffering from AKI who received CKRT adult mode treatment
Key inclusion criteria (5 listed)
- All patients with an indication for the extracorporeal blood treatment suffering from AKI who received CKRT adult mode treatment for at least once with: Heparin-Continuous veno-venous hemofiltration Hep-CVVH (Pre CVVH, Post CVVH and Pre-Post CVVH), Heparin-Continuous veno-venous hemodialysis Hep-CVVHD, Heparin-Continuous veno-venous hemodiafiltration Hep-CVVHDF (Pre-CVVHDF and Post-CVVHDF), Citrate-Calcium(Ci-Ca)-CVVHD, Citrate-Calcium(Ci-Ca) CVVHDF, between January 2015 and January 2024, with the investigational device, have to be included in the study in chronological order.
- No age restriction for heparin modes
- Age ≥ 18 years for Ci-Ca modes at treatment start
- Patient´s body weight ≥ 40kg irrespective of age
- Acute Kidney Injury (AKI) OR chronic dialysis patients with clinical indication for CKRT
Key exclusion criteria (3 listed)
- Participation in an interventional clinical study during the retrospectively collected CKRT treatment data
- Previous participation in the same study
- No study-specific exclusion criteria based on contraindications due to the retrospective character of the 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 |
|---|---|---|
| multiFiltratePRO with all CKRT treatment modesRetrospective Data Analysis of CKRT treatments in adult mode with multiFiltratePRO | Other | AKI patients |
Primary outcome
Analysis of treatments with multiFiltratePRO
Time frame: documentation of max.7 treatment days
Performance data of defined multiFiltratePRO CKRT treatments in adult mode with regard to fluid balance (effluent dose) are analysed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- 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. This study is not recruiting at the moment.
Rainer Borgstedt, Dr. med. principal investigator
Evangelisches Klinikum Bethel gGmbH Universitätsklinikum OWL der Universität Bielefeld
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Renal Failure, run by Fresenius Medical Care Deutschland GmbH at 3 sites in Germany.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of treatments with multiFiltratePRO (time frame: documentation of max.7 treatment days). 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 10 Jun 2025.